Bryostatin + Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia or Relapsed Indolent Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2006-08-01
• 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. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus fludarabine in treating patients who have chronic lymphocytic leukemia or relapsed, indolent non-Hodgkin's lymphoma.

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

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bryostatin 1; Fludarabine; Fludarabine phosphate; Vidarabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed chronic lymphocytic leukemia

• Stage I (symptomatic or with bulky lymphadenopathy)

• Stage II, III, or IV

• Prior chemotherapy allowed, including fludarabine or other purine nucleoside analog therapy OR

• Histologically confirmed indolent non-Hodgkin's lymphoma

• Progressive or relapsed following chemotherapy

• Includes the following histologies:

• B-cell chronic lymphocytic leukemia/prolymphocytic leukemia/lymphomas

• Lymphoplasmacytoid lymphoma (Waldenstrom's)/immunocytoma

• Mantle cell lymphoma

• Follicular lymphoma

• Small cell

• Mixed small and large cell

• Diffuse (predominately small cell type)

• Marginal zone B-cell lymphoma

• Extranodal (MALT-type with or without monocytoid B-cells)

• Provisional subtype: nodal (with or without monocytoid B-cells)

• Provisional entity: splenic marginal zone lymphoma (with or without villous lymphocytes)

• Hairy cell leukemia

• Peripheral T-cell and NK-cell neoplasms

• T-cell chronic lymphocytic leukemia/polylymphocytic leukemia

• Large granular lymphocyte leukemia

• T-cell type

• NK-cell type

• Mycosis fungoides/Sezary's syndrome (cutaneous T-cell lymphoma)

• No CNS disease

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,000/mm3

• Platelet count at least 75,000/mm3

• Hemoglobin at least 8 g/dL

• Coombs negative

Hepatic:

• AST/ALT no greater than 2.5 times upper limit of normal

• Bilirubin no greater than 2 mg/mL

Renal:

• Creatinine clearance at least 40 mL/min

Other:

• No concurrent neurologic condition

• No other concurrent medical condition that would preclude study

• Not pregnant or nursing

• Fertile patients must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent systemic immunoglobulin therapy

• No prior bone marrow or peripheral stem cell transplantation

Chemotherapy:

• See Disease Characteristics

• At least 3 weeks since prior systemic chemotherapy

Endocrine therapy:

• No concurrent systemic glucocorticoid therapy

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No other concurrent anticancer therapy