NCT00052403撤回1 期
Phase I Study of Monoclonal Antibody Anti-Anb3 Integrin in Patients With Advanced Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
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 solid tumors.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose and recommended phase II dose of monoclonal antibody anti-anb3 integrin in patients with advanced solid tumors.
- Determine the toxic effects of this drug in these patients.
- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
- Determine the potential anti-tumor activity of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive monoclonal antibody anti-anb3 integrin IV over 30 minutes weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody anti-anb3 integrin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated as above at that dose level.
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
- 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 solid tumor that is unresponsive to currently available therapies or for which no known effective treatment exists
- •Measurable or evaluable disease
- •Must have clinical or radiological evidence of disease
- •Disease must be accessible to biopsy and imaging studies
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Eastern Cooperative Oncology Group (ECOG) 0-2
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Absolute neutrophil count at least 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •No prior bleeding disorder
- •Bilirubin no greater than 1.2 mg/dL
- •alanine aminotransferase test (ALT) and Aspartate Aminotransferase (AST) no greater than 2.5 times upper limit of normal (ULN)
- •Prothrombin time (PT)/ partial thromboplastin time (PTT) no greater than ULN
- •Creatinine less than 1.5 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after study
- •Willing to be premedicated for delayed contrast-enhanced MRI
- •No prior claustrophobia
- •No dementia or altered mental status that would preclude informed consent
- •No other uncontrolled concurrent illness
- •No ongoing or active infection
- •No psychiatric illness or social situations that would preclude study compliance
- •No immunodeficiency
- •HIV negative
- •Must be willing to receive blood products
- •No thyroid disease
- •Thyroxine and thyroid-stimulating hormone no greater than ULN
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 4 weeks since prior immunotherapy
排除标准
- •Chemotherapy
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •Prior taxanes allowed
- •No concurrent chemotherapy
- •Endocrine therapy
- •No concurrent hormonal therapy except:
- •Concurrent hormonal replacement therapy
- •Concurrent medication for maintaining castrate status in patients with progressive hormone refractory prostate cancer
- •Radiotherapy
- •At least 4 weeks since prior radiotherapy and recovered
- •No prior radiotherapy to more than 25% of the bone marrow
- •No concurrent radiotherapy
- •More than 4 weeks since prior surgery
- •No other concurrent investigational or commercial agents or therapies for the malignancy
- •No other concurrent antitumor therapy
研究者
Patricia LoRusso
Principal Investigator
Barbara Ann Karmanos Cancer Institute
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