Bryostatin 1 and Rituximab in Treating Patients With B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as bryostatin 1, work in 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. Bryostatin 1 may help rituximab kill more cancer cells by making them more sensitive to the drug.

PURPOSE: This phase II trial is studying how well giving bryostatin 1 together with rituximab works in treating patients with B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia that has not responded to previous treatment with rituximab.

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

Details

• Lead Sponsor: National Institute on Aging (NIA)
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bryostatin 1; Rituximab

Criteria

DISEASE CHARACTERISTICS:

• One of the following histologically or cytologically confirmed diseases:

• Indolent B-cell non-Hodgkin's lymphoma (NHL)

• Stage II-IV disease

• Chronic lymphocytic leukemia (CLL) meeting 1 of the following risk criteria:

• Intermediate-risk with progressive disease

• High-risk, modified Rai stage disease

• CD20-positive by flow cytometry or immunohistochemistry

• Measurable disease

• Rituximab-refractory disease, defined as failure to achieve a response to the last course of prior treatment with rituximab alone or in combination with other therapeutic modalities

• No known neoplastic leptomeningeal involvement and/or brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2 OR

• Karnofsky 60-100%

Life expectancy

• More than 3 months

Hematopoietic

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

• Platelet count ≥ 50,000/mm^3

• WBC ≥ 3,000/mm^3

Hepatic

• AST and ALT ≤ 2.5 times upper limit of normal

• Bilirubin normal (unless due to Gilbert's disease or organ involvement by NHL or CLL)

Renal

• Creatinine normal OR

• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No history of anaphylaxis or immunoglobulin (Ig) E-mediated hypersensitivity to murine protein

• Prior infusion reactions to rituximab without an IgE component allowed

• No active or ongoing infection

• No psychiatric illness or social situation that would preclude study compliance

• No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

• See Radiotherapy

• At least 12 weeks since prior rituximab

• More than 4 weeks since prior immunotherapy and recovered

Chemotherapy

• No more than 3 prior chemotherapy regimens

• More than 4 weeks since prior chemotherapy and recovered

Endocrine therapy

• No concurrent glucocorticoids

Radiotherapy

• At least 12 weeks since prior radioimmunotherapy

• More than 4 weeks since prior radiotherapy and recovered

Surgery

• Not specified

Other

• At least 4 weeks since prior therapy for the malignancy

• No other concurrent anticancer therapy

• No other concurrent investigational agents