Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplant in Treating Patients With Lymphoma

• Status: Completed
• Trial end date: 2010-01-01
• 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 chemotherapy with monoclonal antibody therapy, total-body irradiation, and peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving chemotherapy with rituximab followed by combination chemotherapy with or without rituximab, total-body irradiation, and peripheral stem cell transplant works in treating patients with lymphoma.

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

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Bristol-Myers Squibb; Genentech, Inc.; National Cancer Institute (NCI)
• Treatments: Carboplatin; Cyclophosphamide; Doxorubicin; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard; Liposomal doxorubicin; Prednisone; Rituximab; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed aggressive diffuse large B-cell lymphoma

• CD20-positive disease

• Age-adjusted International Prognostic Index II or III defined by the presence of at least 1 of the following:

• Karnofsky performance status 10-70%

• Lactate dehydrogenase greater than 200 U/L

• Stage III or IV disease

• Positron emission tomography avid measurable disease

• No CNS involvement

PATIENT CHARACTERISTICS:

Age:

• 18 to 64

Performance status:

• See Disease Characteristics

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count greater than 1,000/mm^3

• Platelet count greater than 50,000/mm^3

Hepatic:

• Bilirubin less than 2.0 mg/dL unless history of Gilbert's disease or pattern consistent with Gilbert's disease

• Hepatitis B surface antigen and hepatitis C antibody negative

• No chronic, active, or persistent hepatitis

Renal:

• Creatinine no greater than 1.5 mg/dL OR

• Creatinine clearance greater than 60 mL/min

• No chronic renal insufficiency

Cardiovascular:

• Ejection fraction at least 50% by echocardiogram or MUGA scan

• No myocardial infarction within the past 6 months

• No unstable angina

• No cardiac arrhythmias except chronic atrial fibrillation

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception

• HIV negative

• No other medical illness that would preclude study

• No uncontrolled infection

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior biologic therapy for malignancy

Chemotherapy:

• No prior chemotherapy for malignancy

Endocrine therapy:

• Prior steroids allowed if received no more than 1 week of therapy

Radiotherapy:

• No prior radiotherapy for malignancy

Surgery:

• No prior surgery for malignancy

Other:

• No other prior therapy for malignancy