LymphomaPhase 2NCT00002715
Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma
A Phase 2 study testing Bleomycin sulfate, Stanford V regimen and Doxorubicin hydrochloride in people with Lymphoma, run by Stanford University at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- Bleomycin sulfate, Stanford V regimen and Doxorubicin hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1989to Oct 2015
- Phase
- Phase 2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
DISEASE CHARACTERISTICS:
- Histologically confirmed Hodgkin's lymphoma of any histology
- Unfavorable disease required
- Clinical stage IIIA, IIIB, IV, or IIB (non-bulky)
- Locally extensive stage I or II with either of the following:
- Mediastinal mass greater than 1/3 the maximum intrathoracic diameter
- Two or more extranodal sites
PATIENT CHARACTERISTICS:
Age:
- 18 to 60
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No prior malignancy except nonmelanomatous skin cancer
- No significant concurrent illness that precludes protocol participation
PRIOR CONCURRENT THERAPY:
- No prior treatment for Hodgkin's lymphoma
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: A Phase II Pilot Study of Short Term (12 Week) Combination Chemotherapy (Stanford V) in Unfavorable Hodgkin's Disease
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced Hodgkin's lymphoma.
Read the detailed description
OBJECTIVES:
- Determine the feasibility of short term chemotherapy with the Stanford V regimen (mechlorethamine, doxorubicin, vinblastine, prednisone, vincristine, bleomycin, and etoposide) followed by, as indicated, consolidative radiotherapy in patients with stage IIB, IIIA, IIIB, or IV Hodgkin's lymphoma.
- Determine the initial response to 8 weeks of Stanford V chemotherapy in these patients.
- Assess the complete and partial response rate to 12 weeks of Stanford V chemotherapy in these patients.
- Determine the acute toxicity associated with this treatment.
- Determine the disease free interval and survival following Stanford V chemotherapy with or without consolidative radiotherapy in these patients.
OUTLINE: All patients are treated on Regimen A with the Stanford V Regimen; those with initial bulky, residual, or splenic disease who achieve a CR/PR proceed to Regimen B.
- Regimen A: Patients receive mechlorethamine IV on weeks 1, 5, and 9; doxorubicin and vinblastine IV on weeks 1, 3, 5, 7, 9, and 11; vincristine and bleomycin IV on weeks 2, 4, 6, 8, 10, and 12; etoposide IV over 30-45 minutes for 2 consecutive days on weeks 3, 7, and 11; and prednisone orally every other day on days 1-84. Treatment continues for 8-12 weeks, depending on response, in the absence of disease progression or unacceptable toxicity.
- Regimen B: Patients begin radiotherapy 2-4 weeks after completion of Regimen A. Patients receive radiotherapy to lungs, pleura, and other extralymphatic sites for approximately 5 weeks.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 50 patients will be entered if at least 16 of the first 22 patients respond. As of 03/96, it is expected that a total of 45 patients each with stage III/IV disease and 40 with unfavorable stage II disease will be accrued.
- Conditions
- Lymphoma
- Being tested
- Bleomycin sulfate, Stanford V regimen, Doxorubicin hydrochloride, Etoposide, Mechlorethamine hydrochloride
- Keywords
- Stage I adult Hodgkin lymphoma, Stage II adult Hodgkin lymphoma, Stage III adult Hodgkin lymphoma, Stage IV adult Hodgkin lymphoma, Adult lymphocyte predominant Hodgkin lymphoma, Adult lymphocyte depletion Hodgkin lymphoma, Adult nodular sclerosis Hodgkin lymphoma, Adult mixed cellularity Hodgkin lymphoma
- Medical subject headings
- Lymphoma, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bleomycin sulfateBiological
A component of the Stanford V regimen.
Stanford V regimenDrug
A component of the Stanford V regimen.
EtoposideDrug
A component of the Stanford V regimen.
Mechlorethamine hydrochlorideDrug
A component of the Stanford V regimen.
PrednisoneDrug
A component of the Stanford V regimen.
VinblastineDrug
A component of the Stanford V regimen.
A component of the Stanford V regimen.
| Study group | Role | What they receive |
|---|---|---|
| Combination Chemotherapy (Stanford V) | Experimental | A combination chemotherapy regimen consisting of mechlorethamine, doxorubicin hydrochloride, vinblastine, vincristine, bleomycin, etoposide and prednisone, administered on a compressed schedule Receives: Biological: Bleomycin sulfate; Drug: Stanford V regimen; Drug: Doxorubicin hydrochloride; Drug: Etoposide; Drug: Mechlorethamine hydrochloride; Drug: Prednisone; Drug: Vinblastine; Drug: Vincristine sulfate |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startApr 1989
- Primary completionJan 2007
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sandra J. Horning, MD, Study chair, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002715
- Sponsor's protocol ID
- IRB-13467
- Other IDs
- SUMC-G2/G3, CDR0000064551, SQL 76234, NCI-H96-0806
- Status last verified
- Aug 2020
- First submitted
- 1 Nov 1999
- Last updated
- 12 Aug 2020
- Results posted
- No
Publications
Horning SJ, Rosenberg SA, Hoppe RT. Brief chemotherapy (Stanford V) and adjuvant radiotherapy for bulky or advanced Hodgkin's disease: an update. Ann Oncol. 1996;7 Suppl 4:105-8. doi: 10.1093/annonc/7.suppl_4.s105.
PubMed 8836420Bartlett NL, Rosenberg SA, Hoppe RT, Hancock SL, Horning SJ. Brief chemotherapy, Stanford V, and adjuvant radiotherapy for bulky or advanced-stage Hodgkin's disease: a preliminary report. J Clin Oncol. 1995 May;13(5):1080-8. doi: 10.1200/JCO.1995.13.5.1080.
PubMed 7537796
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Pilot Study of Short Term (12 Week) Combination Chemotherapy (Stanford V) in Unfavorable Hodgkin's Disease
- ClinicalTrials.gov ID
- NCT00002715
- Acronym / sponsor ID
- IRB-13467
- Conditions
- Lymphoma
- Keywords
- Stage I adult Hodgkin lymphoma, Stage II adult Hodgkin lymphoma, Stage III adult Hodgkin lymphoma, Stage IV adult Hodgkin lymphoma, Adult lymphocyte predominant Hodgkin lymphoma, Adult lymphocyte depletion Hodgkin lymphoma, Adult nodular sclerosis Hodgkin lymphoma, Adult mixed cellularity Hodgkin lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 1989 (actual)
- Primary completion
- Jan 2007 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 27 Jan 2003 (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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced Hodgkin's lymphoma.
Detailed description
OBJECTIVES:
- Determine the feasibility of short term chemotherapy with the Stanford V regimen (mechlorethamine, doxorubicin, vinblastine, prednisone, vincristine, bleomycin, and etoposide) followed by, as indicated, consolidative radiotherapy in patients with stage IIB, IIIA, IIIB, or IV Hodgkin's lymphoma.
- Determine the initial response to 8 weeks of Stanford V chemotherapy in these patients.
- Assess the complete and partial response rate to 12 weeks of Stanford V chemotherapy in these patients.
- Determine the acute toxicity associated with this treatment.
- Determine the disease free interval and survival following Stanford V chemotherapy with or without consolidative radiotherapy in these patients.
OUTLINE: All patients are treated on Regimen A with the Stanford V Regimen; those with initial bulky, residual, or splenic disease who achieve a CR/PR proceed to Regimen B.
- Regimen A: Patients receive mechlorethamine IV on weeks 1, 5, and 9; doxorubicin and vinblastine IV on weeks 1, 3, 5, 7, 9, and 11; vincristine and bleomycin IV on weeks 2, 4, 6, 8, 10, and 12; etoposide IV over 30-45 minutes for 2 consecutive days on weeks 3, 7, and 11; and prednisone orally every other day on days 1-84. Treatment continues for 8-12 weeks, depending on response, in the absence of disease progression or unacceptable toxicity.
- Regimen B: Patients begin radiotherapy 2-4 weeks after completion of Regimen A. Patients receive radiotherapy to lungs, pleura, and other extralymphatic sites for approximately 5 weeks.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 50 patients will be entered if at least 16 of the first 22 patients respond. As of 03/96, it is expected that a total of 45 patients each with stage III/IV disease and 40 with unfavorable stage II disease will be accrued.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination Chemotherapy (Stanford V) | Experimental | Biological: Bleomycin sulfate, Drug: Stanford V regimen, Drug: Doxorubicin hydrochloride, Drug: Etoposide, Drug: Mechlorethamine hydrochloride, Drug: Prednisone, Drug: Vinblastine, Drug: Vincristine sulfateA combination chemotherapy regimen consisting of mechlorethamine, doxorubicin hydrochloride, vinblastine, vincristine, bleomycin, etoposide and prednisone, administered on a compressed schedule |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 sulfateA component of the Stanford V regimen. | Biological | Combination Chemotherapy (Stanford V) |
| Stanford V regimen | Drug | Combination Chemotherapy (Stanford V) |
| Doxorubicin hydrochlorideA component of the Stanford V regimen. | Drug | Combination Chemotherapy (Stanford V) |
| EtoposideA component of the Stanford V regimen. | Drug | Combination Chemotherapy (Stanford V) |
| Mechlorethamine hydrochlorideA component of the Stanford V regimen. | Drug | Combination Chemotherapy (Stanford V) |
| PrednisoneA component of the Stanford V regimen. | Drug | Combination Chemotherapy (Stanford V) |
| VinblastineA component of the Stanford V regimen. | Drug | Combination Chemotherapy (Stanford V) |
| Vincristine sulfateA component of the Stanford V regimen. | Drug | Combination Chemotherapy (Stanford V) |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Results publication: PubMed 8836420Horning SJ, Rosenberg SA, Hoppe RT. Brief chemotherapy (Stanford V) and adjuvant radiotherapy for bulky or advanced Hodgkin's disease: an update. Ann Oncol. 1996;7 Suppl 4:105-8. doi: 10.1093/annonc/7.suppl_4.s105.
- Results publication: PubMed 7537796Bartlett NL, Rosenberg SA, Hoppe RT, Hancock SL, Horning SJ. Brief chemotherapy, Stanford V, and adjuvant radiotherapy for bulky or advanced-stage Hodgkin's disease: a preliminary report. J Clin Oncol. 1995 May;13(5):1080-8. doi: 10.1200/JCO.1995.13.5.1080.
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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.
Sandra J. Horning, MD study chair
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bleomycin sulfate, Stanford V regimen and Doxorubicin hydrochloride in people with Lymphoma, run by Stanford University at 1 site 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?
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 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
On the ClinicalTrials.gov record for NCT00002715, which also lists 2 linked publications.
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 12 Aug 2020.