Phase II Study of Antineoplastons A10 and AS2-1 Capsules With Total Androgen Blockade in Patients With Stage III or IV Adenocarcinoma of the Prostate
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 stage III or stage IV prostate cancer.
详细描述
OBJECTIVES:
- Determine the antitumor activity of antineoplastons A10 and AS2-1 capsules in combination with total androgen blockade in patients with localized, regional or metastatic adenocarcinoma of the prostate 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 antineoplastons A10 and AS2-1 capsules orally 6-7 times daily until the maximum tolerated dose is reached. Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity. Concurrently, patients continue hormonal therapy with flutamide, leuprolide, or bicalutamide at the same dose as before beginning antineoplaston therapy.
Tumors are measured every 4 months for 2 years, every 6 months for 2 years, and then annually for 2 years.
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 proven localized, regional, or metastatic adenocarcinoma of the prostate
- •Progressive disease during prior hormonal therapy (both antiandrogen and gonadotropin-releasing hormone) and must continue hormonal therapy
- •Measurable tumors or tumor markers
- •Bone metastases allowed
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Platelet count at least 100,000/mm^3
- •No hepatic failure
- •Bilirubin no greater than 2.5 mg/dL
- •SGOT no greater than 2 times normal
- •No chronic renal failure
- •BUN less than 60 mg/dL
- •Creatinine no greater than 2.5 mg/dL OR
- •Creatinine clearance greater than 60 mL/min
- •Blood ammonia normal
- •Cardiovascular:
- •No severe heart disease
- •No severe lung disease
- •Fertile patients must use effective contraception during and for 4 weeks after study participation
- •No serious active infections or fever
- •No other prior or concurrent second malignancy within the past 2 years
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior biologic therapy and recovered
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy and recovered
- •Endocrine therapy:
- •See Disease Characteristics
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy and recovered
- •Not specified
- •At least 4 weeks since prior investigational clinical trial
- •No other concurrent treatment for metastatic prostate cancer
排除标准
- 未提供