Breast Cancer
Conditions
Keywords
stage IV breast cancer, recurrent breast cancer
Brief 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.
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.
Interventions
DRUGbryostatin 1
Sponsors
National Cancer Institute (NCI)
University of Colorado, Denver
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed