Bryostatin 1 in Treating Patients With Stage IV Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00003205
First received: November 1, 1999
Last updated: May 28, 2013
Last verified: December 2002
  Purpose

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 Intervention Phase
Breast Cancer
Drug: bryostatin 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Trial of Bryostatin-1 for the Treatment of Stage IV Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Study Start Date: April 1998
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003205

Locations
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Study Chair: Andrew S. Kraft, MD University of Colorado, Denver
  More Information

Additional Information:
No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00003205     History of Changes
Other Study ID Numbers: 97-0751.cc, UCHSC-97751, NCI-T97-0063
Study First Received: November 1, 1999
Last Updated: May 28, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on April 22, 2014