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

February 4, 2013 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas - MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Jorge E. Romaguera, MD, M.D. Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1996

Primary Completion (Actual)

April 1, 2000

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

June 22, 2004

First Posted (Estimate)

June 23, 2004

Study Record Updates

Last Update Posted (Estimate)

February 5, 2013

Last Update Submitted That Met QC Criteria

February 4, 2013

Last Verified

October 1, 2000

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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