Combination Chemotherapy in Treating Patients With Lymphoma

• Status: Completed
• Trial end date: 2004-02-04
• 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 chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating patients who have intermediate-grade or immunoblastic lymphoma.

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

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bleomycin; Carmustine; Cisplatin; Cyclophosphamide; Cytarabine; Etoposide; Etoposide phosphate; Idarubicin; Ifosfamide; Interferon-alpha; Interferons; Isophosphamide mustard; Lenograstim; Leucovorin; Levoleucovorin; Melphalan; Methotrexate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Mitoxantrone; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of previously untreated intermediate-grade or immunoblastic lymphoma

• Tumor score of 3 or greater, defined by the presence of 3 or more of the following criteria :

• Ann Arbor stage III or IV disease

• B symptoms (fever, sweats, and weight loss greater than 10%)

• At least 1 tumor mass greater than 7 cm or mediastinal mass visible on plain chest x-ray

• Beta-2 microglobulin at least 3.0

• Lactic dehydrogenase at least 1.1 times the upper limit of normal

• T- and B-cell lymphomas allowed if intermediate grade or immunoblastic

• Divergent histologies, including bone marrow involvement, allowed

• CNS involvement allowed NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

• 15 to 59

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin less than 2.0 mg/dL (unless elevation due to lymphoma)

Renal:

• Creatinine no greater than 1.5 mg/dL (unless elevation due to lymphoma)

Cardiovascular:

• LVEF greater than 50% by echocardiogram if over age 45

• No congestive heart failure, angina, history of myocardial infarction, or arrhythmia unless cleared by principal investigator after cardiology consultation

Pulmonary:

• No history of chronic obstructive or restrictive lung disease

• Pulmonary consultation required for smokers or patients with questionable lung function

Other:

• HIV negative

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No prior malignancy with poor prognosis (less than 90% probability of surviving for 5 years)

• No geographic, economic, emotional, or social condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior biologic therapy

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• No prior endocrine therapy

Radiotherapy

• No prior radiotherapy

Surgery

• Not specified