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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002725

Enrollment

Registered

2004-06-23

Start date

1996-08-31

Completion date

Unknown

Last updated

2013-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

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

Brief summary

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

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.

Interventions

DRUGbryostatin 1

DRUGchemotherapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026