Rituximab and Liposomal Doxorubicin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with liposomal doxorubicin may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects of giving rituximab together with liposomal doxorubicin and to see how well they work in treating patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborator: Ortho Biotech, Inc.
• Treatments: Doxorubicin; Liposomal doxorubicin; Rituximab

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following indolent or aggressive B-cell non-Hodgkin's lymphoma (NHL) subtypes:

• Grade 1-3 follicular lymphoma

• Mantle cell lymphoma

• Small lymphocytic lymphoma

• Diffuse large B-cell lymphoma

• Diffuse mixed cell lymphoma

• Marginal zone lymphoma

• Relapsed or refractory CD20-positive disease

• Measurable disease

• Must have received ≥ 1 but < 4 prior standard chemotherapy regimens

• No Burkitt's lymphoma or precursor B-lymphoblastic lymphoma

• No CNS lymphoma

PATIENT CHARACTERISTICS:

Performance status

• Karnofsky 60-100%

Life expectancy

• At least 6 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 75,000/mm^3

• Hemoglobin > 7 g/dL

Hepatic

• AST or ALT < 2 times upper limit of normal (unless due to primary disease)

• Bilirubin ≤ 2 mg/dL

Renal

• Creatinine ≤ 2.0 mg/dL

Cardiovascular

• LVEF ≥ 50% by MUGA and/or 2-D echocardiogram

• No history of New York Heart Association class II-IV cardiac disease

• No congestive heart failure

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No known HIV positivity

• No uncontrolled active bacterial, viral, or fungal infection

• No other serious disease that would preclude study participation

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Recovered from prior immunotherapy

• Prior immunotherapy, including rituximab or other monoclonal antibody, allowed

Chemotherapy

• See Disease Characteristics

• More than 4 weeks since prior chemotherapy and recovered

• No prior doxorubicin (or equivalent anthracycline) at a cumulative dose > 400 mg/m^2

• No other concurrent chemotherapy

Endocrine therapy

• Nonsteroidal hormones for nonlymphoma-related conditions (e.g., insulin for diabetes) allowed

• No concurrent corticosteroids except for a transient inflammatory reaction (i.e., skin rash or hives)

Radiotherapy

• Recovered from prior radiotherapy

• No concurrent radiotherapy

Surgery

• More than 4 weeks since prior major surgery (other than diagnostic surgery) and recovered

Other

• No other concurrent antitumor agents

• No other concurrent investigational agents