NCT00006009已完成1 期
A Phase I, Multiple Dose Escalation Trial of Intravenous Humanized Anti-CD3 Antibody (HuM291) in Patients With CD3+ T-cell Lymphomas
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced or recurrent lymphoma.
详细描述
OBJECTIVES:
- Determine the safety and tolerability of monoclonal antibody HuM291 in patients with advanced or recurrent CD3+ T-cell lymphomas.
- Evaluate the pharmacokinetics and pharmacodynamics of this treatment regimen in this patient population.
- Determine the response in these patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive monoclonal antibody HuM291 IV over 3 hours on days 1-4 in the absence of unacceptable toxicity. Patients achieving a partial response, complete response with recurrence, or stable disease may receive further therapy.
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody HuM291 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity.
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 CD3+ T-cell lymphoma for which no standard curative therapy exists
- •Peripheral T-cell lymphoma
- •Recurrent and/or progressive disease after at least 1 prior therapy
- •Mycosis fungoides
- •Stage IB/IIA
- •Recurrent and/or progressive disease after at least 2 prior therapies
- •Stage IIB-IVB
- •Recurrent and/or progressive disease after at least 1 prior therapy
- •All other T-cell lymphomas
- •Recurrent and/or progressive disease after at least 1 prior therapy
- •Evaluable disease
- •Any nodal site or mass lesion at least 1.5 cm in longest axis on physical exam or CT scan
- •Skin lesions at least 1 cm in longest axis for cutaneous lymphoma
- •High numbers of circulating T-cells allowed
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 50-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 2,000/mm^3*
- •Absolute neutrophil count at least 1,000/mm^3*
- •Platelet count at least 75,000/mm^3* NOTE: * Unless due to lymphoma
- •Bilirubin no greater than 2.0 times normal*
- •AST/ALT no greater than 2.5 times upper limit of normal*
- •Hepatitis B and C negative NOTE: * Unless due to lymphoma
- •Not specified
- •Cardiovascular:
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No other uncontrolled illness
- •No ongoing or active infection
- •No other active malignancies except basal cell skin cancer or carcinoma in situ of the cervix
- •HIV-1 negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Biologic therapy:
- •At least 60 days since prior humanized or chimeric antibody therapy
- •Chemotherapy:
- •At least 3 weeks since prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 3 weeks since prior radiotherapy
- 另有 2 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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