Chemotherapy Followed by Radiation Therapy and Peripheral Stem Cell Transplant Compared With Chemotherapy Plus Interferon Alfa in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether giving more than one drug (combination chemotherapy) with radiation therapy and peripheral stem cell transplant is more effective than chemotherapy followed by interferon alfa in treating mantle cell lymphoma.

PURPOSE: This randomized phase III trial compares how well chemotherapy followed by radiation therapy, chemotherapy, and peripheral stem cell transplant works compared to chemotherapy plus interferon alfa in treating patients who have stage III or stage IV mantle cell lymphoma.

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

Details

• Lead Sponsor: German Low Grade Lymphoma Study Group
• Collaborators: European Organisation for Research and Treatment of Cancer - EORTC; Gruppo Italiano Studio Linfomi; Lymphoma Study Association
• Treatments: Carmustine; Cyclophosphamide; Cytarabine; Dexamethasone; Etoposide; Interferon-alpha; Interferons; Melphalan

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage III or IV mantle cell lymphoma

• Previously untreated

• Not qualified for primary potentially curative radiotherapy

PATIENT CHARACTERISTICS:

Age:

• 18 to 65 years

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• No impairment of liver function (unless due to lymphoma)

• Transaminases no greater than 3 times normal

• Bilirubin no greater than 2.0 mg/dL

Renal:

• No renal insufficiency

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• No manifest heart failure or coronary heart disease

• No severe uncontrolled hypertension

Pulmonary:

• No chronic lung disease with hypoxemia

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No severe uncontrolled diabetes mellitus

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior interferon

• No prior organ, bone marrow, or peripheral blood stem cell transplantation

Chemotherapy:

• No prior cytostatic chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• Not specified