Rituximab, Prednisone, Cyclophosphamide, Doxorubicin, Vincristine, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Previously Untreated Mantle Cell Lymphoma

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as prednisone, cyclophosphamide, doxorubicin, and vincristine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab and combination chemotherapy together with yttrium Y 90 ibritumomab tiuxetan works in treating patients with previously untreated mantle cell lymphoma.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Antibodies, Monoclonal; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Prednisone; Rituximab; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed mantle cell lymphoma with expression of bcl-1 and CD20

• Stage II-IV disease

• Measurable or evaluable disease

• Measurable disease defined as at least 1 bidimensionally measurable lesion at least 2 cm by imaging scan

• A spleen at least 17 cm or having discrete filling defects by CT scan will constitute evaluable disease provided that no explanation other than lymphomatous involvement (e.g., portal hypertension or other liver disease) is likely

• No known CNS lymphoma

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 6 months

Hematopoietic

• WBC greater than 2,500/mm^3*

• Platelet count greater than 100,000/mm^3* NOTE: *Unless due to disease in bone marrow

Hepatic

• Bilirubin less than 1.5 mg/dL (1.5-3.0 mg/dL if due to liver involvement by lymphoma)

• ALT and AST no greater than 2.5 times upper limit of normal (unless due to liver involvement by lymphoma)

Renal

• Creatinine less than 2.0 mg/dL

• Calcium no greater than 11.5 mg/dL

Cardiovascular

• LVEF greater than 45%

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 1 year after study participation

• HIV negative

• No other malignancy except treated carcinoma in situ of the cervix or squamous cell or basal cell skin cancer or any other surgically cured malignancy from which the patient has been disease-free for at least 3 years

• No other concurrent serious medical condition or active infection that would preclude ability to deliver standard prednisone, cyclophosphamide, doxorubicin, and vincristine (CHOP) chemotherapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior immunotherapy

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Prior corticosteroids allowed provided the course was no more than 2 weeks in duration

Radiotherapy

• No prior radiotherapy

Surgery

• Not specified