NCT00006347Unknown1 期
Phase I Non-Myeloablative Trial With 90Y-Humanized MN-14 (Anti-CEA) Antibody for Relapsed or Refractory Small Cell Lung Cancer (SCLC)
Garden State Cancer Center at the Center for Molecular Medicine and Immunology2 个研究点 分布在 1 个国家开始时间: 2000年8月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 试验地点
- 2
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 relapsed or refractory small cell lung cancer.
详细描述
OBJECTIVES:
- Determine the dose limiting toxicity and maximum tolerated dose of yttrium Y 90 anti-CEA monoclonal antibody MN-14 in patients with relapsed or refractory small cell lung cancer.
- Determine the dosimetric and pharmacokinetic properties of this treatment regimen in the blood, normal organs, and tumors of these patients.
- Determine the stability and complexation with circulating carcinoembryonic antigen of this radioantibody in the plasma of these patients.
- Determine the antibody response of these patients treated with this regimen.
- Determine the antitumor effects of this treatment regimen in these patients.
OUTLINE: This is a dose escalation study of yttrium Y 90 anti-CEA monoclonal antibody MN-14 (90Y-hMN-14). Patients are stratified according to prior radiotherapy (yes vs no).
Patients undergo pretherapy imaging with indium In 111 anti-CEA monoclonal antibody MN-14 IV over 30-40 minutes on day -7 or -6 followed by external scintigraphy on days -7 or -6 to 0.
Patients who show positive localization of at least one documented tumor site receive 90Y-hMN-14 IV over 30-40 minutes on day 0.
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 or cytologically confirmed small cell lung cancer (SCLC)
- •Must have received at least one prior course of standard chemotherapy and, if indicated, up to 6,900 cGy of thoracic radiotherapy
- •Patients who received prior radiotherapy must show evidence of progressive disease
- •Patients who received no prior radiotherapy to the primary tumor must show evidence of stable or progressive disease
- •Measurable disease
- •Must have evidence of carcinoembryonic antigen (CEA) production or expression documented by one of the following:
- •Serum CEA at least 10 ng/mL
- •Positive immunohistology of either the primary tumor or a metastasis with CEA specific monoclonal antibody
- •Must have unilateral bone marrow biopsy with less than 25% tumor involvement
- •No known, active brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 2 mg/dL
- •AST no greater than 2 times upper limit of normal (ULN)
- •No hepatitis B or C
- •No other serious liver abnormality
- •Creatinine no greater than 1.5 times ULN
- •No urinary incontinence
- •Cardiovascular:
- •Ejection fraction at least 50%
- •FEV_1 and FVC at least 60%
- •DLCO at least 50% predicted
- •No severe anorexia, nausea, or vomiting
- •No other significant medical problems
- •No prisoners
- •No reactivity to humanized MN-14 (in patients with prior exposure to chimeric or humanized antibody)
- •HIV negative
- •No active HIV-related disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 3 months following study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Chemotherapy
- •No concurrent growth factors (e.g., filgrastim [G-CSF])
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy
- •No prior high dose chemotherapy with stem cell transplantation
- •Endocrine therapy:
- •Not specified
- 另有 5 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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