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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00002725

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: bryostatin 1 Drug: chemotherapy	Phase 2

Detailed Description

OBJECTIVES:

Determine the response to bryostatin 1 (BRYO) administered weekly for 3 weeks in patients with relapsed non-Hodgkin's lymphoma.
Assess the toxic effects of this treatment. III. Establish the correlation between PKC isoenzyme activity and BRYO function in lymphoma cells and normal lymphocytes.
Determine the pharmacokinetic profile of BRYO and its relationship to pharmacodynamics.

OUTLINE:

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

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 1996

Actual Primary Completion Date :

Apr 1, 2000

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I Single-Agent Chemotherapy/Differentiation Therapy. Bryostatin 1, BRYO, NSC-339555.	Drug: bryostatin 1 Drug: chemotherapy

Arm

Intervention/Treatment

Experimental: Arm I

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

Drug: bryostatin 1

Drug: chemotherapy

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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