Epirubicin and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy such as epirubicin 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 epirubicin with rituximab may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining epirubicin with rituximab in treating patients who have relapsed or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

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

Details

• Lead Sponsor: Fox Chase Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Epirubicin; Rituximab

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed B-cell non-Hodgkin's lymphoma (any grade) or chronic lymphocytic leukemia meeting 1 of the following criteria:

• Primary refractory disease

• Disease progression after at least 1 but no more than 4 prior cytotoxic chemotherapy regimens

• Rituximab administered alone is not considered 1 prior regimen

• High-dose chemotherapy with stem cell support is considered 1 prior regimen

• Bidimensionally measurable or evaluable disease outside prior irradiation port

• No clinical evidence of CNS involvement

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Neutrophil count at least 2,000/mm^3*

• Platelet count at least 100,000/mm^3* NOTE: *Unless due to bone marrow involvement

Hepatic

• Bilirubin no greater than 1.5 mg/dL

• SGOT and SGPT no greater than 2 times upper limit of normal (ULN)

Renal

• Creatinine no greater than 2 times ULN

Cardiovascular

• No unstable angina

• No uncontrolled congestive heart failure

• LVEF at least 45%

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after study treatment

• HIV negative

• No other concurrent primary malignancy except basal cell or squamous cell skin cancer, carcinoma in situ, or localized solid tumors cured more than 5 years ago

• No acute infection requiring systemic therapy

• No confusion, disorientation, or major psychiatric illness that would preclude understanding of informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

• At least 4 weeks since prior biologic therapy

Chemotherapy

• See Disease Characteristics

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

• Prior cumulative doxorubicin dose no greater than 6 courses at 50 mg/m^2

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

• No prior radiotherapy to the entire pelvis

• At least 4 weeks since prior radiotherapy

Surgery

• Not specified

Other

• More than 7 days since prior cimetidine

• No concurrent cimetidine