LymphomaNCT00416377
Radiation Therapy or Combination Chemotherapy in Treating Young Patients With Hodgkin's Lymphoma
A study testing bleomycin sulfate, chlorambucil and dacarbazine in people with Lymphoma, run by Children's Cancer and Leukaemia Group.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphoma
- What is being tested?
- bleomycin sulfate, chlorambucil and dacarbazine
- Type of treatment
- Surgery or procedure
- How many people
- 353 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed childhood Hodgkin's lymphoma by lymph node biopsy
- Any stage disease
- Patients with bilateral upper cervical disease with no evidence of supraclavicular, thoracic inlet, or Waldeyers ring involvement are treated as having stage I disease
PATIENT CHARACTERISTICS:
- Platelet count > 100,000/mm^3
- Absolute neutrophil count > 1,000/mm^3
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Hodgkin's Disease Study
RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This clinical trial is studying how well radiation therapy or combination chemotherapy work in treating young patients with Hodgkin's lymphoma.
Read the detailed description
OBJECTIVES:
- Maintain the present satisfactory results of patients treated on protocol UKCCSG-HD-8201 in pediatric patients with stage I-III Hodgkin's lymphoma treated with radiotherapy or combination chemotherapy comprising chlorambucil, procarbazine hydrochloride, prednisolone, vinblastine followed by doxorubicin hydrochloride, bleomycin, vincristine, and dacarbazine.
- Determine, by comparison with UKCCSG-HD-8201, if mediastinal irradiation can be safely omitted from the management of pediatric patients with Hodgkin's lymphoma and bulky mediastinal disease.
- Determine if gallium scanning of the mediastinum after chemotherapy will identify patients with residual active mediastinal disease.
- Improve disease control in patients with stage IV Hodgkin's lymphoma and slow responders by intensifying treatment to patients who fail to achieve complete remission after 4 courses of chlorambucil, vinblastine, procarbazine hydrochloride, and prednisone.
OUTLINE: This is a multicenter study. Patients are stratified according to stage of disease (I vs II-IV).
- Stage I: Patients undergo involved-field radiotherapy.
- Stage II-IV:
- CHLVPP chemotherapy: Patients receive CHLVPP chemotherapy comprising oral chlorambucil, oral procarbazine hydrochloride, and oral prednisolone on days 1-14 and vinblastine IV on days 1-8. Treatment repeats every 28 days for 2 courses. Patients achieving complete resolution (CR) of measurable disease receive an additional 4 courses of CHLVPP. Patients with no response or progressive disease proceed to ABVD chemotherapy. Patients with shrinkage of measurable disease to < 50% original dimensions (GPR) receive 2 additional courses of CHLVPP. Patients achieving CR or GPR after completion of 2 additional courses of CHLVPP receive 4 more courses of CHLVPP. Patients achieving shrinkage of measurable disease to ≥ 50% of original dimension (PR) after 2 additional courses of CHLVPP OR patients not achieving CR after a total of 8 courses of CHLVPP proceed to ABVD chemotherapy.
- ABVD chemotherapy: Patients receive ABVD chemotherapy comprising doxorubicin hydrochloride IV over 4 hours and bleomycin IV, vincristine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
- Mediastinal mass: Patients receive chemotherapy as per stages II-IV. Patients presenting with airway or superior vena cava obstruction may also undergo radiotherapy. Patients achieving CR after completion of chemotherapy receive no further treatment. Patients achieving GPR or PR after completion of chemotherapy undergo gallium scan and CT scan of thorax with or without biopsy at the investigator's discretion.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 353 patients were accrued for this study.
- Conditions
- Lymphoma
- Being tested
- bleomycin sulfate, chlorambucil, dacarbazine, doxorubicin hydrochloride, prednisolone
- Keywords
- stage I childhood Hodgkin lymphoma, stage II childhood Hodgkin lymphoma, stage III childhood Hodgkin lymphoma, stage IV childhood Hodgkin lymphoma, recurrent/refractory childhood Hodgkin lymphoma
- Medical subject headings
- Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bleomycin sulfateBiological
chlorambucilDrug
dacarbazineDrug
prednisoloneDrug
procarbazine hydrochlorideDrug
vinblastine sulfateDrug
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 353 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Cancer and Leukaemia Group
- Sponsor type
- University, hospital or other
- Investigators
- Ann Barrett, Study chair, University of GlasgowJudith E. Kingston, MD, St. Bartholomew's HospitalJohn Martin, MD, Royal Liverpool Children's Hospital, Alder Hey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416377
- Sponsor's protocol ID
- CCLG-HD-9201
- Other IDs
- CDR0000454741, EU-20586
- Status last verified
- Dec 2006
- First submitted
- 27 Dec 2006
- Last updated
- 2 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hodgkin's Disease Study
- ClinicalTrials.gov ID
- NCT00416377
- Acronym / sponsor ID
- CCLG-HD-9201
- Conditions
- Lymphoma
- Keywords
- stage I childhood Hodgkin lymphoma, stage II childhood Hodgkin lymphoma, stage III childhood Hodgkin lymphoma, stage IV childhood Hodgkin lymphoma, recurrent/refractory childhood Hodgkin lymphoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 353 participants (estimated)
- Lead sponsor
- Children's Cancer and Leukaemia GroupUniversity, hospital or other
- First posted
- 28 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This clinical trial is studying how well radiation therapy or combination chemotherapy work in treating young patients with Hodgkin's lymphoma.
Detailed description
OBJECTIVES:
- Maintain the present satisfactory results of patients treated on protocol UKCCSG-HD-8201 in pediatric patients with stage I-III Hodgkin's lymphoma treated with radiotherapy or combination chemotherapy comprising chlorambucil, procarbazine hydrochloride, prednisolone, vinblastine followed by doxorubicin hydrochloride, bleomycin, vincristine, and dacarbazine.
- Determine, by comparison with UKCCSG-HD-8201, if mediastinal irradiation can be safely omitted from the management of pediatric patients with Hodgkin's lymphoma and bulky mediastinal disease.
- Determine if gallium scanning of the mediastinum after chemotherapy will identify patients with residual active mediastinal disease.
- Improve disease control in patients with stage IV Hodgkin's lymphoma and slow responders by intensifying treatment to patients who fail to achieve complete remission after 4 courses of chlorambucil, vinblastine, procarbazine hydrochloride, and prednisone.
OUTLINE: This is a multicenter study. Patients are stratified according to stage of disease (I vs II-IV).
- Stage I: Patients undergo involved-field radiotherapy.
- Stage II-IV:
- CHLVPP chemotherapy: Patients receive CHLVPP chemotherapy comprising oral chlorambucil, oral procarbazine hydrochloride, and oral prednisolone on days 1-14 and vinblastine IV on days 1-8. Treatment repeats every 28 days for 2 courses. Patients achieving complete resolution (CR) of measurable disease receive an additional 4 courses of CHLVPP. Patients with no response or progressive disease proceed to ABVD chemotherapy. Patients with shrinkage of measurable disease to < 50% original dimensions (GPR) receive 2 additional courses of CHLVPP. Patients achieving CR or GPR after completion of 2 additional courses of CHLVPP receive 4 more courses of CHLVPP. Patients achieving shrinkage of measurable disease to ≥ 50% of original dimension (PR) after 2 additional courses of CHLVPP OR patients not achieving CR after a total of 8 courses of CHLVPP proceed to ABVD chemotherapy.
- ABVD chemotherapy: Patients receive ABVD chemotherapy comprising doxorubicin hydrochloride IV over 4 hours and bleomycin IV, vincristine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
- Mediastinal mass: Patients receive chemotherapy as per stages II-IV. Patients presenting with airway or superior vena cava obstruction may also undergo radiotherapy. Patients achieving CR after completion of chemotherapy receive no further treatment. Patients achieving GPR or PR after completion of chemotherapy undergo gallium scan and CT scan of thorax with or without biopsy at the investigator's discretion.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 353 patients were accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| bleomycin sulfate | Biological | – |
| chlorambucil | Drug | – |
| dacarbazine | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| prednisolone | Drug | – |
| procarbazine hydrochloride | Drug | – |
| vinblastine sulfate | Drug | – |
| vincristine sulfate | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
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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.
Ann Barrett study chair
University of Glasgow
Judith E. Kingston, MD
St. Bartholomew's Hospital
John Martin, MD
Royal Liverpool Children's Hospital, Alder Hey
Questions about this trial
What is this clinical trial studying?
A study testing bleomycin sulfate, chlorambucil and dacarbazine in people with Lymphoma, run by Children's Cancer and Leukaemia Group.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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.
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 2 Aug 2013.