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

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Lymphoma

Treatments: Drug: bryostatin 1; Drug: chemotherapy

Study type: Interventional

Funder types: NIH

Identifiers

NCT00002725

MDA-DM-95061

CDR0000064591 (Registry Identifier)

NCI-2012-02239

NCI-T95-0035D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Arm I

Experimental group

Description:

Single-Agent Chemotherapy/Differentiation Therapy. Bryostatin 1, BRYO, NSC-339555.

Treatment:

Drug: bryostatin 1

Drug: chemotherapy