Bryostatin 1 in Treating Patients With Stage IV Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003205
• Other study ID #: 97-0751.cc
• Secondary ID: UCHSC-97751NCI-T
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: May 28, 2013
• Start date: April 1998
• Est. completion date: April 2004

Study information

• Verified date: December 2002
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• bryostatin 1

Locations

Country	Name	City	State
United States	University of Colorado Cancer Center	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,