bryostatin 1 in treating patients with stage iv breast cancer

Conditions: Breast Cancer

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.

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.

Eligibility 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

Keywords: stage iv breast cancer recurrent breast cancer