Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Aggressive Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining peripheral stem cell transplantation with more than one drug regimen may kill more tumor cells. It is not known whether receiving standard combination chemotherapy alone is more effective than receiving multiple combination chemotherapy plus peripheral stem cell transplantation for aggressive non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is comparing giving different combination chemotherapy regimens together with peripheral stem cell transplantation to see how well they work in treating patients with newly diagnosed aggressive non-Hodgkin's lymphoma.

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

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Treatments: Cortisol succinate; Cyclophosphamide; Cytarabine; Doxorubicin; Etoposide; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Leucovorin; Levoleucovorin; Liposomal doxorubicin; Melphalan; Methotrexate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Mitoxantrone; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL)

• Diffuse large B-cell lymphoma

• Primary mediastinal large B-cell lymphoma

• Anaplastic large cell lymphoma (B-cell, T-cell, or null-cell type)

• At least two of the following risk factors:

• Stage III or IV

• LDH greater than upper limit of normal (ULN)

• ECOG 2, 3, or 4

• No CNS involvement

PATIENT CHARACTERISTICS:

Age:

• 18 to 60

Performance status:

• See Disease Characteristics

• ECOG 0-4

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• No hepatitis B or C

• AST or ALT no greater than 2 times ULN*

• Bilirubin no greater than 2.34 mg/dL* NOTE: *Unless due to tumor involvement

Renal:

• Creatinine clearance at least 60 mL/min (unless due to tumor involvement)

Cardiovascular:

• No significant heart failure

• LVEF normal

• No active angina pectoris

• No myocardial infarction within the past 6 months

• No major ventricular arrhythmia

Pulmonary:

• No significant lung disorder

Other:

• HIV negative

• No severe active acute or chronic infection

• No severe psychoses

• No prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or nonmelanomatous skin cancer

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for NHL (except emergency therapy, but no more than 1 course of standard chemotherapy)

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy for NHL (except emergency therapy of no greater than 600 cGy radiation)

• No concurrent prophylactic radiotherapy to the brain

Surgery:

• Not specified