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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 22, 2014