Expired Study
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Denver, Colorado 80010


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.


Study summary:

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.


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


NCT ID:

NCT00003205


Primary Contact:

Study Chair
Andrew S. Kraft, MD
University of Colorado, Denver


Backup Contact:

N/A


Location Contact:

Denver, Colorado 80010
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2017

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