Bryostatin 1 in Treating Patients With Stage IV Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003205
Recruitment Status : Completed
First Posted : April 23, 2003
Last Update Posted : May 30, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: bryostatin 1 Phase 2

Detailed Description:


  • 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  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Bryostatin-1 for the Treatment of Stage IV Breast Cancer
Study Start Date : April 1998
Actual Primary Completion Date : April 2004
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Menopausal status:

  • Not specified

Performance status:

  • SWOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy:

  • At least 18 weeks


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


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


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


  • 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


Biologic therapy:

  • No concurrent immunotherapy


  • 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


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


  • Not specified


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003205

United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
Sponsors and Collaborators
University of Colorado, Denver
National Cancer Institute (NCI)
Study Chair: Andrew S. Kraft, MD University of Colorado, Denver

Responsible Party: University of Colorado, Denver Identifier: NCT00003205     History of Changes
Other Study ID Numbers:
First Posted: April 23, 2003    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: December 2002

Keywords provided by University of Colorado, Denver:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Bryostatin 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents