Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin's Lymphoma

• Status: Active, not recruiting
• 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. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating stage III or stage IV Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have stage III or stage IV Hodgkin's lymphoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Collaborators: Australasian Leukaemia and Lymphoma Group; Grup per l'Estudi dels Limfomes de Catalunya i Balears; Lymphoma Study Association; Lymphoma Trials Office; NCIC Clinical Trials Group; Nordic Lymphoma Group
• Treatments: Bleomycin; Cyclophosphamide; Dacarbazine; Doxorubicin; Etoposide; Liposomal doxorubicin; Prednisone; Procarbazine; Vinblastine; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed Hodgkin's lymphoma

• No lymphocyte predominant, nodular type (nodular paragranuloma)

• Clinical stage III or IV disease

• At least 1 bidimensionally measurable target lesion or extranodal lesion

• International Prognostic Score of at least 3

PATIENT CHARACTERISTICS:

Age

• 16 to 60

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC greater than 2,000/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic

• No prior uncontrolled hepatitis B viral infection

• Bilirubin no greater than 2.5 times normal (unless due to Hodgkin's lymphoma)

Renal

• Creatinine no greater than 2.0 mg/dL (unless due to Hodgkin's lymphoma)

Cardiovascular

• No severe cardiac disease that would limit normal life expectancy or preclude study

• LVEF at least 50%

Pulmonary

• No severe pulmonary disease that would limit normal life expectancy or preclude study

• Respiratory function at least 30%

Other

• HIV negative

• HTLV1 negative

• No severe active infection

• No severe neurological or metabolic disease that would limit normal life expectancy or preclude study

• No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix

• No psychological, familial, sociological, or geographical condition that would preclude study

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• No concurrent radiotherapy

Surgery

• Not specified

Other

• No prior therapy for Hodgkin's lymphoma