NCT00059995已完成1 期
Phase I/II Open Label, Dose-Escalating Study of MDX-060 Administered Weekly for 4 Weeks in Patients With Refractory/Relapsed CD30 Lymphoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 5
研究概览
简要总结
RATIONALE: Monoclonal antibodies such as MDX-060 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase I/II trial to study the effectiveness of MDX-060 monoclonal antibody in treating patients who have refractory or relapsed lymphoma.
详细描述
OBJECTIVES:
- Determine the safety and tolerability of MDX-060 monoclonal antibody in patients with refractory or relapsed CD30-positive lymphoma.
- Determine the maximum tolerated dose and dose-limiting toxicity of this drug in these patients.
- Determine the pharmacokinetic profile of this drug in these patients.
- Determine, preliminarily, the efficacy (antilymphoma activity) of this drug in these patients.
OUTLINE: This is an open-label, multicenter, dose-escalation study.
Patients receive MDX-060 monoclonal antibody IV over 90 minutes once weekly for 4 weeks.
Cohorts of 3-6 patients receive escalating doses of MDX-060 monoclonal antibody until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 16 patients are accrued and receive MDX-060 monoclonal antibody at the MTD.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed B-cell or T-cell lymphoma
- •Hodgkin's lymphoma and anaplastic large cell lymphoma eligible
- •No HIV-associated lymphoma
- •CD30-positive disease by biopsy, flow cytometry, or immunohistochemistry
- •At least 50% of malignant cells (specifically Reed-Sternberg cells for Hodgkin's lymphoma) must express CD30
- •Must meet one of the following criteria for relapsed/refractory disease:
- •Relapsed after prior chemotherapy or radiotherapy and autologous or allogeneic bone marrow transplantation (if appropriate)
- •Relapsed disease must be within the prior irradiated field
- •Disease that is refractory to prior chemotherapy or radiotherapy with no other curative treatment option
- •Disease progression must be within the prior irradiated field
- •Progressive and evaluable disease (measurable disease required for patients accrued on study after the maximum tolerated dose is determined)
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •WBC at least 1,500/mm^3*
- •Neutrophil count at least 1,000/mm^3*
- •Platelet count at least 75,000/mm^3*
- •Hemoglobin at least 8.0 g/dL* NOTE: *Laboratory abnormalities attributable to organ involvement by lymphoma are allowed
- •AST no greater than 2 times upper limit of normal (ULN)*
- •Bilirubin no greater than 2.0 mg/dL (unless due to Gilbert's syndrome)*
- •Hepatitis B surface antigen negative
- •Hepatitis C antibody negative NOTE: *Laboratory abnormalities attributable to organ involvement by lymphoma are allowed
- •Creatinine no greater than 2 times ULN* NOTE: *Laboratory abnormalities attributable to organ involvement by lymphoma are allowed
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception during and for 9 months after study participation
- •HIV negative
- •No other active malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •No active significant infection
- •No apparent opportunistic infection, as indicated by any of the following:
- •Purified protein derivative recently determined to be positive
- •Infectious infiltrate by chest x-ray
- •Recent changes in fever/chill patterns
- •New, unexplained neurological symptoms
- •No underlying medical condition that would preclude receiving study therapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •No prior anti-CD30 antibody therapy
- •No other concurrent biologic therapy
- •Chemotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy
- •No concurrent systemic steroidal therapy (excluding physiologic doses)
- •Radiotherapy
- 另有 5 项未显示
排除标准
- 未提供
研究者
研究点 (5)
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