NCT00003205已完成2 期
A Phase II Trial of Bryostatin-1 for the Treatment of Stage IV Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
- •Bilirubin no greater than 1.2 mg/dL
- •Transaminases no greater than 3 times normal
- •Creatinine no greater than 1.6 mg/dL OR
- •Creatinine clearance at least 70 mL/min
- •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
- •Not specified
- •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
- 另有 2 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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