S0213 Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma

• Status: Completed
• Trial end date: 2011-06-01
• 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. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining rituximab with chemotherapy may kill more cancer cells.

PURPOSE: Phase II pilot study to study the effectiveness of combining chemotherapy with rituximab in treating patients who have newly diagnosed mantle cell lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: BB 1101; Cyclophosphamide; Cytarabine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Lenograstim; Leucovorin; Levoleucovorin; Liposomal doxorubicin; Methotrexate; Rituximab; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven stage III/IV or bulky stage II mantle cell lymphoma of one of the following histologic subtypes:

• Nodular

• Diffuse

• Mantle zone

• Blastic

• Newly diagnosed and previously untreated disease

• Bidimensionally measurable disease

PATIENT CHARACTERISTICS:

Age:

• 18 to 69

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,000/mm^3

• Platelet count at least 100,000/mm^3 (50,000/mm^3 if marrow involvement present)

Hepatic:

• Bilirubin no greater than 1.5 mg/dL (5.0 mg/dL if hepatic involvement present)

Renal:

• Creatinine no greater than 2.0 mg/dL

• Creatinine clearance greater than 50 mL/min

Cardiovascular:

• Ejection fraction at least 50% by MUGA or 2-D echocardiogram

• No significant abnormalities by EKG

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• Willing to receive blood product transfusions

• No known sensitivity to E. coli-derived proteins

• No known AIDS syndrome or HIV-associated complex

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior monoclonal antibody therapy

Chemotherapy:

• No prior chemotherapy for lymphoma

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy for lymphoma

Surgery:

• Not specified