Bryostatin-1 in Treating Patients With Recurrent Non-Hodgkin's Lymphoma

Study Overview
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Brief Summary
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Phase II trial to study the effectiveness of bryostatin-1 in treating patients with recurrent non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

Detailed Description
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OBJECTIVES: I. Determine the response to bryostatin 1 (BRYO) administered weekly for 3 weeks in patients with relapsed non-Hodgkin's lymphoma. II. Assess the toxic effects of this treatment. III. Establish the correlation between PKC isoenzyme activity and BRYO function in lymphoma cells and normal lymphocytes. IV. Determine the pharmacokinetic profile of BRYO and its relationship to pharmacodynamics. OUTLINE: Single-Agent Chemotherapy/Differentiation Therapy. Bryostatin 1, BRYO, NSC-339555.

Official Title
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PHASE II EVALUATION OF BRYOSTATIN-1 (NSC 339555) IN NON-HODGKIN'S LYMPHOMA

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: bryostatin 1
* Drug: chemotherapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed non-Hodgkin's lymphoma Working formulation low-, intermediate-, and high-grade histologies eligible Mantle cell and marginal zone lymphoma eligible Relapse after at least 1 doxorubicin-containing regimen required No more than 2 prior chemotherapy regimens One prior biologic therapy in addition to the 2 prior chemotherapy regimens allowed No prior bone marrow transplantation Ineligible for treatment on higher priority protocols Patients eligible for bone marrow transplantation may be treated to reduce tumor bulk Bidimensionally measurable disease required No history of primary or metastatic CNS disease PATIENT CHARACTERISTICS: Age: Any age Performance status: Zubrod 0-2 Life expectancy: Greater than 12 weeks Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Bilirubin no greater than 1.8 mg/dL Transaminases no greater than 2.5 times normal Creatinine no greater than 1.5 mg/dL OR creatinine clearance greater than 70 mL/min No HIV antibody No serious intercurrent illness No pregnant or nursing women Effective contraception required of fertile patients throughout study and for 1 year thereafter PRIOR CONCURRENT THERAPY: -At least 4 weeks since prior therapy (6 weeks since mitomycin) and recovered
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Single-Agent Chemotherapy/Differentiation Therapy. Bryostatin 1, BRYO, NSC-339555. | Drug: bryostatin 1<br> <br> Drug: chemotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent small lymphocytic lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma