Rituximab, Cyclophosphamide, and G-CSF Followed By Combination Chemotherapy in Treating Patients Who Are Undergoing Autologous Stem Cell Transplant Followed By Rituximab and GM-CSF for Refractory Diffuse Large B-Cell Lymphoma

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving colony-stimulating factors, such as G-CSF, monoclonal antibodies, such as rituximab, and chemotherapy, such as cyclophosphamide, helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for peripheral stem cell transplant. Giving chemotherapy, such as carmustine, etoposide, and cyclophosphamide, before transplant stops the growth of cancer cells by stopping them from dividing or killing them. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. More rituximab is given after transplant to kill any remaining cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with cyclophosphamide and G-CSF followed by combination chemotherapy works in treating patients undergoing an autologous stem cell transplant followed by rituximab and GM-CSF for refractory diffuse large B-cell lymphoma.

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

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carmustine; Cyclophosphamide; Etoposide; Rituximab; Sargramostim

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of diffuse large B-cell lymphoma, meeting 1 of the following criteria:

• Failed to achieve at least partial remission

• Failed to respond to prior primary therapy or salvage chemotherapy

• Disease progression within 6 weeks after achieving remission

• CD20 expression at diagnosis or relapse

• No more than 4 prior regimens using chemotherapy, radiotherapy, or immunotherapy

• The addition of radiotherapy or a monoclonal antibody to chemotherapy is considered 1 treatment regimen provided the addition was part of the initial treatment plan

• The addition of these therapies due to lack of response or poor response is considered an additional treatment regimen whether given in the front line or salvage setting

PATIENT CHARACTERISTICS:

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,000/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• Direct bilirubin ≤ 2 mg/dL

• AST or ALT < 3 times upper limit of normal

Renal

• Creatinine ≤ 2.0 mg/dL

Cardiovascular

• Ejection fraction ≥ 40%

Pulmonary

• DLCO ≥ 60% of predicted

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• No active infection requiring oral or IV antibiotics

• HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

• See Radiotherapy

Chemotherapy

• See Disease Characteristics

Radiotherapy

• See Disease Characteristics

• No prior radioimmunotherapy