Bryostatin 1 in Treating Patients With Stage IV Breast Cancer

May 28, 2013 updated by: University of Colorado, Denver

A Phase II Trial of Bryostatin-1 for the Treatment of Stage IV Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients with stage IV breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the clinical response of patients with stage IV breast cancer to bryostatin 1.
  • Determine the efficacy of this regimen in these patients.
  • Estimate the pharmacokinetic parameters of bryostatin 1 when given as 24 hour infusion.
  • Determine the ability of this regimen to regulate lymphocyte function in these patients.
  • Determine the effect of this regimen on platelet function and protein kinase C activity in these patients.

OUTLINE: Patients receive bryostatin 1 IV over 24 hours. Treatment continues weekly in the absence of disease progression or unacceptable toxicity.

Patients are followed every 4-8 weeks for tumor response.

PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.

Study Type

Interventional

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

  • United States
    • Colorado
      • Denver, Colorado, United States, 80010
        • University of Colorado 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Unequivocal diagnosis of metastatic breast cancer
  • Bidimensionally measurable disease
  • No uncontrolled CNS metastases
  • No disease that is evaluable only, including blastic bone disease, malignant ascites, and malignant pleural effusion

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Menopausal status:

  • Not specified

Performance status:

  • SWOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy:

  • At least 18 weeks

Hematopoietic:

  • Platelet count at least 50,000/mm^3
  • PT and PTT within normal limits
  • Neutrophil count at least 2,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.2 mg/dL
  • Transaminases no greater than 3 times normal

Renal:

  • Creatinine no greater than 1.6 mg/dL OR
  • Creatinine clearance at least 70 mL/min

Other:

  • No active infections requiring antibiotics
  • No viral hepatitis allowed
  • Seronegative for hepatitis B or C
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 2 months following study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunotherapy

Chemotherapy:

  • 2 prior chemotherapy regimens for metastatic disease allowed as adjuvant therapy or for advanced disease (may include high dose chemotherapy with stem cell support)
  • At least 4 weeks since prior chemotherapy
  • At least 6 weeks since prior nitrosourea or mitomycin therapy
  • No other concurrent chemotherapy

Endocrine therapy:

  • 2 prior hormonal therapy regimens for metastatic disease as adjuvant therapy or for advanced diseases allowed
  • At least 2 weeks since prior hormonal therapy (at least 4 weeks in case of disease progression while receiving hormonal therapy after initial response)
  • No concurrent hormonal therapy except oral contraceptives
  • No concurrent use of steroids except for management of severe or life- threatening toxic effects arising from bryostatin 1

Radiotherapy:

  • At least 2 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • No concurrent use of drugs known to interfere with platelet function, such as aspirin or NSAIDs (including ibuprofen)
  • No concurrent use of anticoagulants
  • At least 2 weeks since prior use of aspirin
  • At least 2 days since prior use of NSAIDS
  • Concurrent use of acetaminophen to control pain is allowed
  • If acetaminophen inadequate for pain control, concurrent use of oral narcotics such as codeine or oxycodone is allowed

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

Collaborators and Investigators

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

Sponsor

University of Colorado, Denver

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Andrew S. Kraft, MD, University of Colorado, Denver

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

April 1, 1998

Primary Completion (Actual)

April 1, 2004

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

April 22, 2003

First Posted (Estimate)

April 23, 2003

Study Record Updates

Last Update Posted (Estimate)

May 30, 2013

Last Update Submitted That Met QC Criteria

May 28, 2013

Last Verified

December 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 97-0751.cc
  • UCHSC-97751
  • NCI-T97-0063

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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