Phase II Study of Antineoplastons A10 and AS2-1 Capsules in Patients With Adenocarcinoma of the Colon
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 patients with colon cancer.
详细描述
OBJECTIVES:
- Determine the antitumor activity of antineoplastons A10 and AS2-1 in patients with adenocarcinoma of the colon by determining the proportion of patients 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 gradually escalating doses of oral antineoplaston A10 and oral antineoplaston AS2-1 6-7 times a day. If the patient has not achieved a partial or complete response after 3-4 months of treatment, the investigator may discontinue treatment. Patients with stable disease may continue to receive treatment until disease progression or unacceptable toxicity is observed.
Tumors are measured every 4 months during the first 2 years, then every 6 months during years 3 and 4, and yearly during years 5 and 6.
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 adenocarcinoma of the colon that is unlikely to respond to existing therapy and for which no curative therapy exists
- •Measurable disease by MRI or CT scan
- •Metastatic or unresectable disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •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 serious lung disease, such as chronic obstructive pulmonary disease
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for 4 weeks after study participation
- •No active infection
- •No serious malabsorption syndromes
- •No other serious concurrent disease
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior immunotherapy and recovered
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- •Endocrine therapy:
- •Concurrent corticosteroids allowed
- •Radiotherapy:
- •At least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors may be admitted earlier)
- •No prior extensive stomach or intestinal surgery
- •Prior cytodifferentiating agent allowed
- •No prior antineoplaston therapy
- •No other concurrent anticancer therapy
排除标准
- 未提供