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


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Andrew S. Kraft, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Federal Government

Study ID:

97-0751.cc

NCT ID:

NCT00003205

Start Date:

April 1998

Completion Date:

April 2004

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

University of Colorado Cancer CenterDenver, Colorado  80262