NCT00003502撤回2 期
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Stage II, III, or IV Mantle Cell Lymphoma
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 stage II, stage III, or stage IV mantle cell lymphoma.
详细描述
OBJECTIVES:
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening stage II, III, or IV mantle cell lymphoma.
- Evaluate the response to, tolerance to, and side effects of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 intravenously 6 times daily until the maximum tolerated dose is reached. Treatment continues in the absence of disease progression or unacceptable toxicity.
Tumors are measured every 8 weeks for 6 months, every 3 months for 2 years, every 6 months for the third and fourth years, and then annually thereafter.
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 stage II, III, or IV mantle cell lymphoma that is not curable by surgery, radiotherapy, and/or chemotherapy
- •Measurable tumor of greater than 2 cm in largest diameter for lymph nodes located in head, neck, axillary, inguinal, and femoral areas (at least 1 cm for other areas)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •At least 2 months
- •Hematopoietic:
- •WBC greater than 2000/mm^3
- •Platelet count greater than 20,000/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
- •Creatinine no greater than 2.5 mg/dL
- •No history of renal conditions that contraindicate high dosages of sodium
- •Cardiovascular:
- •No hypertension
- •No history of congestive heart failure
- •No history of cardiovascular conditions that contraindicate high dosages of sodium
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for 4 weeks after study participation
- •No serious active infections requiring treatment
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior immunotherapy and recovered
- •No concurrent immunomodulatory agent (e.g., interferon or interleukin-2)
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- •No concurrent antineoplastic agent
- •Endocrine therapy:
- •At least 4 weeks since prior corticosteroids (e.g., dexamethasone or prednisone)
- •No concurrent dexamethasone, prednisone, or other corticosteroids
- •Radiotherapy:
- •At least 8 weeks since prior radiotherapy and recovered
- •Not specified
- •No prior antineoplaston therapy
- •No concurrent antibiotics, antifungals, or antivirals
排除标准
- 未提供
研究者
研究点 (2)
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