NCT00024232已完成2 期
Pilot Trial of Humanized Monoclonal Antibody J591 in Patients With Progressive Androgen-Independent Prostate Cancer
适应症
试验速览
- 阶段
- 2 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 II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have prostate cancer that has not responded to hormone therapy.
详细描述
OBJECTIVES:
- Determine the antitumor effects of monoclonal antibody huJ591 in patients with progressive androgen-independent prostate cancer.
- Determine the biodistribution and dosimetry of this antibody in these patients.
- Determine the effect on biodistribution of the delivery sequence of unlabeled vs indium In 111-labeled antibody in these patients.
- Determine the HAHA response in patients treated with this regimen.
- Correlate the dose of monoclonal antibody huJ591 with antibody-dependent cellular cytotoxicity in these patients.
OUTLINE: Patients are assigned to one of two treatment groups.
- Group I: Patients receive monoclonal antibody huJ591 IV followed by indium In 111 monoclonal antibody huJ591 on day 1.
- Group II: Patients receive monoclonal antibody huJ591 concurrently with indium In 111 monoclonal antibody huJ591 as in group I.
Treatment in both groups repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable 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
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed prostate cancer
- •Disease progression after prior castration
- •At least 3 rising PSA levels at least 1 week apart OR 2 rising levels at least 4 weeks apart
- •New osseous lesions on bone scan and/or more than 25% increase in bidimensionally measurable soft tissue disease or appearance of new sites of disease by CT scan or MRI
- •Testosterone no greater than 50 ng/mL
- •Medical therapy (e.g., gonadotropin-releasing hormone analogues) to maintain castrate level of testosterone should continue in the absence of surgical orchiectomy
- •Progression of disease after discontinuation of prior anti-androgen therapy
- •No requirement for palliative therapy within the past 12 weeks
- •No active CNS or epidural primary tumor OR active CNS or epidural metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC greater than 3,500/mm3
- •Platelet count greater than 100,000/mm3
- •Bilirubin less than 1.5 mg/dL
- •Gamma-glutamyl-transferase less than upper limit of normal (ULN)
- •AST less than ULN
- •PT less than 14 seconds
- •No prior autoimmune hepatitis
- •Creatinine less than 1.5 mg/dL OR
- •Creatinine clearance greater than 60 mL/min
- •Cardiovascular:
- •No clinically significant cardiac disease (New York Heart Association class III or IV)
- •No severe debilitating pulmonary disease
- •Fertile patients must use effective contraception
- •No active uncontrolled infection or infection requiring IV antibiotics
- •No prior autoimmune disease
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior murine protein for diagnostic or therapeutic purposes
- •No other concurrent anticancer immunotherapy
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy and recovered
- •No concurrent anticancer chemotherapy
- •Endocrine therapy:
- •See Disease Characteristics
- •No concurrent anticancer hormonal therapy
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy and recovered
- •Concurrent radiotherapy to localized sites of disease (e.g., bone) allowed if the site does not contain sole measurable lesion
- •See Disease Characteristics
- •No concurrent surgery
- •Recovered from all prior therapy
- •At least 4 weeks since prior therapeutic investigational anticancer drugs
- •At least 4 weeks since prior participation in therapeutic clinical trial with an experimental drug
- 另有 3 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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