Overview

Combination Chemotherapy and Peripheral Stem Cell Transplant in Treating Patients With Relapsed Hodgkin's Lymphoma

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
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 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
German Hodgkin's Lymphoma Study Group
Collaborators:
EBMT Solid Tumors Working Party
European Organisation for Research and Treatment of Cancer - EORTC
Treatments:
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