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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002725
• Other study ID #: NCI-2012-02239
• Secondary ID: MDA-DM-95061NCI-
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: February 4, 2013
• Start date: August 1996

Study information

• Verified date: October 2000
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. primary completion date: April 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• bryostatin 1

• chemotherapy

Locations

Country	Name	City	State
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,