NCT00003514撤回2 期
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Metastatic or Incurable Neuroendocrine Tumors
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 patients with neuroendocrine tumor that is metastatic or unlikely to respond to surgery or radiation therapy.
详细描述
OBJECTIVES:
- Provide treatment with antineoplastons A10 and AS2-1 for patients with metastatic or incurable neuroendocrine tumors.
- Describe response, tolerance to, and side effects of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of antineoplastons A10 and AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached.
Treatment continues for at least 2 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.
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 incurable neuroendocrine tumor that is unlikely to respond to existing therapy, meeting 1 of the following criteria:
- •Metastatic disease
- •Disease that is not curable with surgery or radiotherapy
- •Measurable disease by MRI or CT scan
- •Tumor must be at least 2 cm
- •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
- •No hepatic insufficiency
- •Bilirubin no greater than 2.5 mg/dL
- •SGOT and SGPT no greater than 5 times upper limit of normal
- •No renal insufficiency
- •Creatinine no greater than 2.5 mg/dL
- •No history of renal conditions that contraindicate high dosages of sodium
- •Cardiovascular:
- •No uncontrolled hypertension
- •No history of congestive heart failure
- •No history of other cardiovascular conditions that contraindicate high dosages of sodium
- •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 concurrent nonmalignant systemic disease
- •Not a high medical or psychiatric risk
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior immunotherapy
- •No concurrent immunomodulating agents
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- •Endocrine therapy:
- •Concurrent corticosteroids allowed
- •Radiotherapy:
- •At least 8 weeks since prior radiotherapy
- •Recovered from prior surgery
- •Prior cytodifferentiating agents allowed
- •No prior antineoplastons
- •No other concurrent antineoplastic agents
排除标准
- 未提供
研究者
研究点 (2)
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