Hodgkin's LymphomaPhase 2NCT00352027
Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma
A Phase 2 study testing Adriamycin®, Vinblastine and Nitrogen Mustard in people with Hodgkin's Lymphoma, run by St. Jude Children's Research Hospital at 6 sites in United States.
Trial summary
The main purpose of this protocol is to estimate the percentage of patients with intermediate risk Hodgkin lymphoma who will survive free of disease (Event-free survival) for three years after treatment with multi-agent chemotherapy (Stanford V) and low-dose, tailored-field radiation therapy. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Hodgkin's Lymphoma
- What is being tested?
- Adriamycin®, Vinblastine and Nitrogen Mustard
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 6 sitesUnited States
- Study dates
- 20 Jul 2006to 15 Nov 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient is less than or equal to 21 years of age
- Patient has a confirmed diagnosis of previously untreated Hodgkin lymphoma
- Has Ann Arbor stage IB, IIIA, or IA/IIA with extranodal extension, multiple nodal involvement (3 or more sites), or bulky mediastinal adenopathy.
Who cannot join
- Patients with favorable risk features
- Patients with unfavorable risk features
- Patients who have received prior therapy for Hodgkin lymphoma.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Stanford University Medical Center
Palo Alto, California, 94304
Maine Children's Medical Center
Portland, Maine, 04102-3175
Rady Children's Hospital San Diego
San Diego, California, 92123
About this study
Official title: Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma
The main purpose of this protocol is to estimate the percentage of patients with intermediate risk Hodgkin lymphoma who will survive free of disease (Event-free survival) for three years after treatment with multi-agent chemotherapy (Stanford V) and low-dose, tailored-field radiation therapy. The hypothesis being studied is that this treatment will result in more than 80% of patients being alive and free of disease three years after starting treatment.
Read the detailed description
Treatment Plan Description:
Adriamycin 25 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11
Vinblastine 6 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11
Nitrogen Mustard 6mg/m2 IV on Day 1 of weeks 1, 5, and 9
Cyclophosphamide 650 mg/m2 IV Day 1 of weeks 1, 5, 9(when Nitrogen Mustard was not available due to national shortage)
Vincristine 1.4 mg/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12
Bleomycin 5 units/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12
Etoposide 60 mg/m2 IV Days 1,2 of weeks 3, 7, 11
Prednisone* 40 mg/m2/day divided in 3 doses PO Every other day of weeks 1-12
G-CSF (only as needed in case of severe myelo-suppression requiring treatment delay) 5 mcg/kg SC Days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)
- Prednisone taper is foreseen for the last 2 weeks of therapy. Patients will be treated with 12 weeks of Stanford V chemotherapy in the schedule outlined above. Patients will then receive radiation therapy after completion of 12 weeks of chemotherapy. The radiation dose to individual nodal sites will be based on response after 8 weeks of chemotherapy: 15 Gy for areas achieving a complete response and 25.5 Gy achieving less than a complete response, or patients with bulky mediastinal mass.
- Conditions
- Hodgkin's Lymphoma
- Being tested
- Adriamycin®, Vinblastine, Nitrogen Mustard, Cyclophosphamide, Vincristine
- Keywords
- Hodgkin's Disease
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adriamycin®Drug
Also called Doxorubicin
Given IV on Day 1 of weeks 1, 3, 5, 7, 9 and 11.
VinblastineDrug
Also called Velban®
Given IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11.
Nitrogen MustardDrug
Also called Mustargen®, Mechlorethamine Hydrochloride
Given IV, Day 1 of weeks 1, 5 and 9. Cyclophosphamide may be substituted if nitrogen mustard is unavailable.
CyclophosphamideDrug
Also called Nitrogen Mustard Derivative
May be substituted if nitrogen mustard is unavailable. Given on Day 1 of weeks 1, 5 and 9.
VincristineDrug
Also called Velban®
Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.
BleomycinDrug
Also called Blenoxane®
Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.
EtoposideDrug
Also called VP-16, Vepesid®
Given IV on Days 1 and 2 of weeks 1-10.
PrednisoneDrug
Also called Synthetic congener of hydrocortisone
Given PO every other day of weeks 1-12.
G-CSFBiological
Also called Filgrastim, Neupogen®
Given subcutaneously days 3-13, 16-26, 29-39, 42-52, 55-65, and 68-78 (as clinically indicated).
RadiotherapyProcedure or surgery
Also called Radiation therapy
Participants receive radiotherapy after completion of 12 weeks of Stanford V chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | Participants receive 12 weeks of Stanford V chemotherapy which includes Adriamycin®, Vinblastine, Nitrogen Mustard (or Cyclophosphamide), Vincristine, Bleomycin, Etoposide, Prednisone, and G-CSF. After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy. Receives: Drug: Adriamycin®; Drug: Vinblastine; Drug: Nitrogen Mustard; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Bleomycin; Drug: Etoposide; Drug: Prednisone; Biological: G-CSF; Procedure: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year Event-Free Survival Probability
The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame.
Measured: 3 years
Secondary outcomes (75)
Disease Failure Rate Within Radiation Fields
Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).
Measured: 3 years
Local and Distant Failure for Children Treated With Tailored-field Radiation
The cumulative incidence of local and distant failure will be estimated. Effect of competing risks will be taken into account. Local failure is defined as in-field, and distant failure is defined as out-of-field.
Measured: from first enrollment date up to 3 years follow-up
Prognostic Factors for Treatment Failure: Age
Age was examined for the association with event-free survival (EFS) which was defined as the interval between date on study and date of relapse/disease progression, second malignant tumor, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance.
Measured: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up
Patient Quality of Life (QoL), PedsQL v.4.0: Total Score
Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Measured: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning
Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Measured: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health
Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Measured: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning
Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Measured: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning
Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Measured: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning
Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Measured: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Total Score
Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt
Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Nausea
Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety
Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety
Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Worry
Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems
Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance
Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Communication
Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), Symptom Distress Scale
The patient's degree of discomfort from specific treatment-related symptoms across multiple time points.
Instrument interpretation: SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Measured: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Measured: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Measured: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Measured: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Measured: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Measured: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Measured: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score
Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Measured: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning
Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Measured: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health
Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Measured: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning
Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Measured: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning
Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Measured: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning
Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Measured: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score
Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt
Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea
Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety
Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety
Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry
Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems
Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance
Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication
Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Measured: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score
Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Measured: 6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning
Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Measured: 6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health
Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Measured: 6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning
Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Measured: 6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning
Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Measured: 6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning
Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Measured: 6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score
Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Measured: 6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt
Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Measured: 6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea
Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Measured: 6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety
Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Measured: 6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety
Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Measured: 6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry
Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Measured: 6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems
Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Measured: 6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance
Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Measured: 6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication
Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Measured: 6 months after the completion of therapy
3-year Event-free Survival (EFS) Probability
Comparison of thee-year EFS probability along with the whole EFS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.
Measured: 3 years
3-year Overall Survival (OS) Probability
Comparison of the 3-year OS probability along with the whole OS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.
Measured: 3-years
3-year Local Failure-free Survival Probability
Comparison of the 3-year local failure-free survival probability along with the whole local failure-free survival distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.
Measured: 3 years
Toxicities With Grade >1
Comparison of the toxicities of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation (current HOD05 protocol) to those patients on HOD99 (NCT00145600). Grading of toxicities for HOD05 and HOD99 used the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Measured: 3 years
Prognostic Factors for Treatment Failure: Gender
Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.
Measured: 3 years follow-up
Prognostic Factors for Treatment Failure: Histology
Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.
Measured: 3 years follow-up
Prognostic Factors for Treatment Failure: Stage
Ann Arbor staging classification was used to stage all patients. Stage was examined (I/II versus III) for the association with event-free survival (EFS), defined as the interval between date on study and of relapse/disease progression, second malignancy, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. Stage <III showed a better outcome but was not statistically significant.
Measured: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)
Echocardiograms will be carried out on the patient at 1, 2, 5, and 10 years after therapy. Outcomes will be categorized.
Measured: 1, 2, 5, and 10 years post therapy
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)
Electrocardiograms (EKGs) will be conducted on the patient at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, determined by the test outcome.
Measured: 1, 2, 5, and 10 years post therapy
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)
Patient pulmonary function will undergo assessment at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, depending on the test results.
Measured: 1, 2, 5, and 10 years post therapy
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)
For patients that received cervical radiation, TSH laboratory testing will be conducted at 1, 2, 5 and 10 years. TSH results will be categorized as Normal, Hypothyroid, Hyperthyroid, or Thyroid Nodule, depending on the test's findings.
Measured: 1, 2, 5, and 10 years post therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2006 (estimated)
- Study start20 Jul 2006
- Primary completionMay 2015
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamie Flerlage, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352027
- Sponsor's protocol ID
- HOD05
- Other IDs
- NCI-2011-01253
- Status last verified
- Sep 2023
- First submitted
- 13 Jul 2006
- Last updated
- 22 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT00352027
- Acronym / sponsor ID
- HOD05
- Conditions
- Hodgkin's Lymphoma
- Keywords
- Hodgkin's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 20 Jul 2006 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 14 Jul 2006 (estimated)
- Results
- Posted 7 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this protocol is to estimate the percentage of patients with intermediate risk Hodgkin lymphoma who will survive free of disease (Event-free survival) for three years after treatment with multi-agent chemotherapy (Stanford V) and low-dose, tailored-field radiation therapy. The hypothesis being studied is that this treatment will result in more than 80% of patients being alive and free of disease three years after starting treatment.
Detailed description
Treatment Plan Description:
Adriamycin 25 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11
Vinblastine 6 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11
Nitrogen Mustard 6mg/m2 IV on Day 1 of weeks 1, 5, and 9
Cyclophosphamide 650 mg/m2 IV Day 1 of weeks 1, 5, 9(when Nitrogen Mustard was not available due to national shortage)
Vincristine 1.4 mg/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12
Bleomycin 5 units/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12
Etoposide 60 mg/m2 IV Days 1,2 of weeks 3, 7, 11
Prednisone* 40 mg/m2/day divided in 3 doses PO Every other day of weeks 1-12
G-CSF (only as needed in case of severe myelo-suppression requiring treatment delay) 5 mcg/kg SC Days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)
- Prednisone taper is foreseen for the last 2 weeks of therapy. Patients will be treated with 12 weeks of Stanford V chemotherapy in the schedule outlined above. Patients will then receive radiation therapy after completion of 12 weeks of chemotherapy. The radiation dose to individual nodal sites will be based on response after 8 weeks of chemotherapy: 15 Gy for areas achieving a complete response and 25.5 Gy achieving less than a complete response, or patients with bulky mediastinal mass.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Drug: Adriamycin®, Drug: Vinblastine, Drug: Nitrogen Mustard, Drug: Cyclophosphamide, Drug: Vincristine, Drug: Bleomycin, Drug: Etoposide, Drug: Prednisone, Biological: G-CSF, Procedure: RadiotherapyParticipants receive 12 weeks of Stanford V chemotherapy which includes Adriamycin®, Vinblastine, Nitrogen Mustard (or Cyclophosphamide), Vincristine, Bleomycin, Etoposide, Prednisone, and G-CSF. After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patient is less than or equal to 21 years of age
- Patient has a confirmed diagnosis of previously untreated Hodgkin lymphoma
- Has Ann Arbor stage IB, IIIA, or IA/IIA with extranodal extension, multiple nodal involvement (3 or more sites), or bulky mediastinal adenopathy.
Key exclusion criteria (3 listed)
- Patients with favorable risk features
- Patients with unfavorable risk features
- Patients who have received prior therapy for Hodgkin lymphoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adriamycin®Also: DoxorubicinGiven IV on Day 1 of weeks 1, 3, 5, 7, 9 and 11. | Drug | All Participants |
| VinblastineAlso: Velban®Given IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11. | Drug | All Participants |
| Nitrogen MustardAlso: Mustargen®, Mechlorethamine HydrochlorideGiven IV, Day 1 of weeks 1, 5 and 9. Cyclophosphamide may be substituted if nitrogen mustard is unavailable. | Drug | All Participants |
| CyclophosphamideAlso: Nitrogen Mustard DerivativeMay be substituted if nitrogen mustard is unavailable. Given on Day 1 of weeks 1, 5 and 9. | Drug | All Participants |
| VincristineAlso: Velban®Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12. | Drug | All Participants |
| BleomycinAlso: Blenoxane®Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12. | Drug | All Participants |
| EtoposideAlso: VP-16, Vepesid®Given IV on Days 1 and 2 of weeks 1-10. | Drug | All Participants |
| PrednisoneAlso: Synthetic congener of hydrocortisoneGiven PO every other day of weeks 1-12. | Drug | All Participants |
| G-CSFAlso: Filgrastim, Neupogen®Given subcutaneously days 3-13, 16-26, 29-39, 42-52, 55-65, and 68-78 (as clinically indicated). | Biological | All Participants |
| RadiotherapyAlso: Radiation therapyParticipants receive radiotherapy after completion of 12 weeks of Stanford V chemotherapy. | Procedure or surgery | All Participants |
Primary outcome
3-year Event-Free Survival Probability
Time frame: 3 years
The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame.
75 secondary outcomes
Disease Failure Rate Within Radiation Fields
Time frame: 3 years
Local and Distant Failure for Children Treated With Tailored-field Radiation
Time frame: from first enrollment date up to 3 years follow-up
Prognostic Factors for Treatment Failure: Age
Time frame: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up
Patient Quality of Life (QoL), PedsQL v.4.0: Total Score
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Total Score
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Nausea
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Worry
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Communication
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), Symptom Distress Scale
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie Flerlage, MD principal investigator
St. Jude Children's Research Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adriamycin®, Vinblastine and Nitrogen Mustard in people with Hodgkin's Lymphoma, run by St. Jude Children's Research Hospital at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year Event-Free Survival Probability (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.