Bryostatin 1 in Treating Patients With Stage IV Breast Cancer

University of Colorado, Denver

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Breast Cancer

Interventions

bryostatin 1DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Colorado Cancer Center

Denver, Colorado, United States

Data from ClinicalTrials.gov

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