Overview
Combination Chemotherapy and Peripheral Stem Cell Transplant in Treating Patients With Relapsed Hodgkin's Lymphoma
Status:
Unknown status
Unknown status
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplant may allow the doctors to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which combination chemotherapy regimen given before peripheral stem cell transplant is more effective in treating relapsed Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is comparing different regimens of combination chemotherapy followed by peripheral stem cell transplant to see how well they work in treating patients with relapsed Hodgkin's lymphoma.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
German Hodgkin's Lymphoma Study GroupCollaborators:
EBMT Solid Tumors Working Party
European Organisation for Research and Treatment of Cancer - EORTCTreatments:
Carmustine
Cyclophosphamide
Cytarabine
Dexamethasone
Etoposide
Melphalan
Methotrexate
Vincristine
Criteria
DISEASE CHARACTERISTICS:- Histologically confirmed Hodgkin's lymphoma
- Early or late first relapse
- Complete or partial remission for at least 3 months after completion of prior
COPP/ABVD, COPP/ABV/IMEP, MOPP/ABV, ABVD, BEACOPP, or other polychemotherapy
regimen with or without radiotherapy
- No prior salvage therapy OR
- Second relapse
- Any prior salvage therapy
- No prior high-dose chemotherapy
PATIENT CHARACTERISTICS:
Age:
- 18 to 60
Performance status:
- Karnofsky 70-100% OR
- ECOG 0-2
Life expectancy:
- More than 3 months with treatment
Hematopoietic:
- Absolute neutrophil count at least 2,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Not specified
Renal:
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No uncontrolled hypertension (diastolic blood pressure greater than 115 mm Hg)
- No unstable angina
- No New York Heart Association class III or IV heart disease (congestive heart failure)
- No myocardial infarction within the past 6 months
- No uncontrolled atrial or ventricular cardiac arrhythmias
Pulmonary:
- No chronic pulmonary disease
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- No active infection
- No poorly controlled diabetes
- No cerebral disorder
- No other concurrent malignancy except adequately treated basal cell skin cancer or
cervical intraepithelial neoplasia
- No significant non-malignant disease
- No psychiatric, addictive, or other disorder that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No other concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
Surgery:
- Not specified
Other:
- At least 6 months since prior coronary angioplasty
- No other concurrent investigational drugs
- No concurrent non-steroidal anti-inflammatory drugs, salicylate, sulfonamide,
trimethoprim, allopurinol, aminoglycoside, amoxicillin, or probenecid during high-dose
methotrexate administration