NCT00003455撤回2 期
Phase II Study of Oral Antineoplastons A10 and AS2-1 in Women With Advanced Breast Cancer
Burzynski Research Institute2 个研究点 分布在 1 个国家开始时间: 2003年1月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.
PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating women with stage IV breast cancer that has not responded to standard therapy.
详细描述
OBJECTIVES:
- Determine the antitumor activity of antineoplastons A10 and AS2-1 capsules in patients with advanced breast cancer by determining the proportion of women who experience an objective tumor response.
- Evaluate the adverse effects of and tolerance to this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive oral antineoplaston A10 and antineoplaston AS2-1 6 to 7 times per day.
Treatment continues for at least 6 weeks. Patients achieving complete or partial response may continue on therapy until disease progression or toxic effects occur.
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:
- •Histologically confirmed stage IV breast cancer that is unlikely to respond to existing therapy and for which no curative therapy exists
- •Failed prior standard therapy
- •Measurable disease by MRI or CT scan
- •Tumor must be at least 2 cm in the lymph nodes in the head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm in other locations
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal Status:
- •Not specified
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •At least 2 months
- •Hematopoietic:
- •WBC at least 2,000/mm^3
- •Platelet count at least 50,000/mm^3
- •Bilirubin no greater than 2.5 mg/dL
- •SGOT/SGPT no greater than 5 times upper limit of normal
- •No hepatic failure
- •Creatinine no greater than 2.5 mg/dL
- •No renal failure
- •Cardiovascular:
- •No chronic heart failure
- •No uncontrolled hypertension
- •No severe lung disease
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for 4 weeks after study participation
- •No serious medical or psychiatric disorders
- •No active infections
- •No other serious concurrent disease
- •No serious malabsorption syndromes
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Recovered from prior immunotherapy
- •At least 4 weeks since prior immunotherapy, except in patients with disease progression during or after initial therapy
- •Chemotherapy:
- •Recovered from prior chemotherapy
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas), except in patients with disease progression during or after initial therapy
- •Endocrine therapy:
- •Recovered from prior hormonal therapy
- •At least 12 weeks since prior hormonal therapy, except in patients with disease progression during and after initial therapy
- •Concurrent corticosteroids for peritumoral edema allowed
- •Radiotherapy:
- •At least 8 weeks since prior radiotherapy and recovered
- •Patients with multiple tumors who have received radiotherapy to some, but not all, tumors may be admitted earlier than 8 weeks
- •Recovered from any prior surgery
- •No prior extensive stomach or intestinal surgery
- •Prior cytodifferentiating agents allowed
- 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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