NCT00001249已完成1 期
Treatment of Tac-Expressing Cutaneous T-Cell Lymphoma (CTCL) and Adult T-Cell Leukemia (ATL) With Yttrium-90 Radiolabeled Anti-Tac
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
研究概览
简要总结
The study purpose is to evaluate the clinical response to multidose administration of anti-Tac monoclonal antibody conjugated with 10 mCi 90Y in patients with Tac-expressing adult T-cell leukemia (ATL).
详细描述
The study purpose is to evaluate the clinical response to multidose administration of anti-Tac monoclonal antibody conjugated with 10 mCi 90Y in patients with Tac-expressing adult T-cell leukemia (ATL). This study represents an extension of phase I trial (Clinical Project #90-C-0043, FDA IND #3469) which permitted the administration of 5 mCi, 10 mCi, and 15mCi 90Y-anti-Tac to patients with ATL. We propose to administer 90Y-anti-Tac (10 mCi doses) to patients with Tac-expressing ATL who are over 18 years of age and who fill the patient eligibility criteria.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adult T-cell leukemia/lymphoma (ATL) or cutaneous T-cell lymphoma (CTCL).
- •Reactivity of at least 10% of peripheral blood, lymph node, or dermal malignant cells with anti-Tac as determined by immunofluorescent staining or soluble IL-2 receptor level greater than 1,500 U required.
- •All stages of Tac-expressing T-cell leukemia and lymphoma eligible except Stage I CTCL.
- •All forms of ATL eligible, including the "smoldering" type as well as aggressive disease.
- •No symptomatic CNS disease other than tropical spastic paraparesis.
- •Asymptomatic CNS disease with demonstrable malignant cells in the CSF allowed (such patients receive CNS therapy, e.g., intrathecal methotrexate and/or CNS irradiation, as appropriate).
- •PRIOR/CONCURRENT THERAPY:
- •Biologic Therapy: Not specified.
- •Chemotherapy:
- •CTCL must have failed initial chemotherapy.
- •ATL may or may not have had prior chemotherapy.
- •At least 4 weeks since prior cytotoxic chemotherapy.
- •Endocrine Therapy: Not specified.
- •Radiotherapy: At least 4 weeks since prior radiotherapy.
- •Surgery: Not specified.
- •PATIENT CHARACTERISTICS:
- •Age: 18 and over.
- •Performance status: Not specified.
- •Life expectancy: Greater than 1 month.
- •Hematopoietic: WBC at least 3,000, Platelets at least 75,
- •Hepatic: Not specified.
- •Renal: Not specified.
- •No pregnant women.
- •Negative pregnancy test required of fertile women.
排除标准
- 未提供
研究者
研究点 (2)
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