NCT00007839Unknown1 期
Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With B-Cell Lymphoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Biological therapies such as beta alethine use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase I/II trial to study the effectiveness of beta alethine in treating patients who have low-grade lymphoma.
详细描述
OBJECTIVES:
- Determine the antitumor effects of low-dose beta-alethine in patients with low grade B-cell lymphoma.
- Assess the effects of this regimen on delayed-type hypersensitivity in these patients.
- Assess the safety of this regimen in this patient population.
OUTLINE: This is an multicenter study.
Patients receive low-dose beta-alethine subcutaneously once every 2 weeks for a total of 6 doses in the absence of unacceptable toxicity. Patients with no evidence of tumor progression may receive additional courses of therapy.
Patients are followed for 2 weeks from the last dose or for a minimum of 30 days if they withdraw due to an adverse event.
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 low grade B-cell lymphoma
- •Measurable residual disease after maximal response to prior chemotherapy OR
- •Indolent disease not yet requiring therapy
- •No congenital immunodeficiency associated lymphoma
- •No primary lymphoma of the brain
- •No active brain involvement or leptomeningeal disease NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 50-100%
- •Life expectancy:
- •At least 4 months
- •Hematopoietic:
- •Neutrophil count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •Hemoglobin at least 10 g/dL
- •Bilirubin less than 2.0 mg/dL
- •SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present)
- •Creatinine no greater than 2.0 mg/dL
- •Calculated creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No uncontrolled angina, heart failure, or arrhythmia
- •No acute changes on EKG
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •HIV negative
- •Adequate nutritional status (total protein at least 60.0 g/L)
- •No active bacterial infections (e.g., abscess or with fistula)
- •No nonmalignant disease that would preclude study
- •No history of alcoholism, drug addiction, or psychotic disorders that would preclude study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Prior bone marrow transplantation allowed
- •At least 4 weeks since prior immunotherapy or cytokines
- •Chemotherapy:
- •See Disease Characteristics
- •Prior intensive chemotherapy with stem cell support allowed
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or high dose carboplatin)
- •Endocrine therapy:
- •No concurrent corticosteroids
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy to more than 25% of bone marrow
- •Recovered from prior surgery
- •No prior solid organ transplantation
- •No concurrent antiinflammatory agents including aspirin, or over the counter or prescription nonsteroidal antiinflammatory drugs
- •No concurrent immunosuppressive agents
- •No other concurrent investigational agents
排除标准
- 未提供
研究者
研究点 (1)
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