A Phase 3 interventional study of bleomycin sulfate and carmustine in Lymphoma, sponsored by SWOG Cancer Research Network. Terminated at 47 sites in United States. Open to participants aged 15 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-01-24.
Sponsored by SWOG Cancer Research Network · Phase 3, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without peripheral stem cell transplantation in treating Hodgkin's Disease.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without peripheral stem cell transplantation in treating men who have stage III or stage IV Hodgkin's disease.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of poor prognostic factors (3 vs 4 vs 5) and stage of disease (III vs IV).
Patients receive induction chemotherapy consisting of doxorubicin IV over 5 minutes, bleomycin IV over 10 minutes, vinblastine IV over 5 minutes, and dacarbazine IV over 15-30 minutes on days 1 and 15. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients who show at least partial response after the fifth course of induction chemotherapy and whose blood counts have recovered are randomized to 1 of 2 treatment arms.
Patients are followed at 60 days, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 460 patients will be accrued for this study within 4 years.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 11 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →SWOG Cancer Research Network is the lead sponsor of 328 studies on the registry; 37 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed stage III or IV Hodgkin's disease with at least 3 of the following characteristics:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Patients receive 5 28-day cycles of ABVD (doxorubicin 25 mg/m\^2, bleomycin 10 U/m\^2, vinblastine 6 mg/m\^2, dacarbazine 375 mg/m\^2 all on days 1 and 15). Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
Biological: bleomycin sulfate · Drug: dacarbazine · Drug: doxorubicin hydrochloride · Drug: vinblastine
Patients receive 5 28-day cycles of ABVD (doxorubicin 25 mg/m\^2, bleomycin 10 U/m\^2, vinblastine 6 mg/m\^2, dacarbazine 375 mg/m\^2 all on days 1 and 15). Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant. Patients randomized to the transplant arm have 2 x 10\^6 CD34+ blood mononuclear cells/kg of actual body weight collected at day -7. High dose therapy consists of BCNU 150/m\^2 on days -6 to -4, etoposide 60 mg/kg on day -4, and cyclophosphamide 100 mg/kg on day -2. Peripheral blood stem cells are infused on day 0.
Biological: bleomycin sulfate · Drug: carmustine · Drug: cyclophosphamide · Drug: dacarbazine · Drug: doxorubicin hydrochloride · Drug: etoposide · Drug: vinblastine · Procedure: peripheral blood stem cell transplantation
10 U/m\^2 given on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
150/m\^2 on days -6 to -4 (4-6 days before transplant).
Also known as: BCNU
100 mg/kg on day -2 (2 days before transplant).
375 mg/m\^2 on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
25 mg/m\^2 on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
60 mg/kg on day -4 (4 days before transplant).
6 mg/m\^2 on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
2 x 10\^6 CD34+ blood mononuclear cells/kg of actual body weight
Progression-free survival
Time frame: every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter
overall survival
Time frame: every 3 months while on treatment, then every 6 months thereafter
This study is terminated, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
SWOG Cancer Research Network