NCT00011973已完成2 期
A Phase Two Study Of Fenretinide In Renal Cell Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 8
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of fenretinide in treating patients who have advanced kidney cancer.
详细描述
OBJECTIVES:
- Determine the response rate of patients with advanced renal cell carcinoma treated with fenretinide.
- Determine progression-free and overall survival of this patient population treated with this drug.
- Determine the quantitative and qualitative toxic effects of this drug in these patients.
OUTLINE: Patients receive oral fenretinide twice a day for 7 days. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
PROJECTED ACCRUAL: Approximately 18-35 patients will be accrued for this study within 9-21 months.
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 locally advanced unresectable, locally recurrent, or metastatic renal cell carcinoma
- •Measurable disease
- •At least 20 mm with conventional techniques OR
- •At least 10 mm with spiral CT scan
- •No nonmeasurable disease only including:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural/pericardial effusion
- •Lymphangitis cutis/pulmonis
- •Abdominal masses not confirmed and followed by imaging techniques
- •Cystic lesions
- •No known brain metastases
- •History of brain metastases that have been resected and/or irradiated with subsequent normal brain CT scan allowed
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy:
- •More than 12 weeks
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •Bilirubin no greater than 1.5 mg/dL
- •AST no greater than 2.5 times upper limit of normal
- •Creatinine no greater than 2 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other prior malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of any site
- •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to fenretinide
- •No other concurrent uncontrolled illness (e.g., ongoing or active infection)
- •No concurrent psychiatric illness or social situation that would preclude study
- •History of HIV allowed if no active infection or history of retinitis
- •No history of retinal disease, night blindness, or difficulty seeing in the dark
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Prior biologic therapy allowed
- •Chemotherapy:
- •No more than 1 prior chemotherapy regimen
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy
- •See Disease Characteristics
- •Recovered from prior therapy
- 另有 3 项未显示
排除标准
- 未提供
研究者
研究点 (8)
Loading locations...
相似试验
已完成
2 期
Fenretinide in Treating Patients With Recurrent or Metastatic Head and Neck CancerHead and Neck CancerNCT00006471M.D. Anderson Cancer Center11
已完成
1 期
Fenretinide in Treating Patients With Solid TumorsUnspecified Adult Solid Tumor, Protocol SpecificNCT00003250Barbara Ann Karmanos Cancer Institute31
已完成
2 期
Fenretinide in Treating Patients With Recurrent Malignant GliomaBrain and Central Nervous System TumorsNCT00006080Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
已完成
1 期
Combination Chemotherapy in Treating Patients With Advanced Solid TumorsUnspecified Adult Solid Tumor, Protocol SpecificNCT00005819Case Comprehensive Cancer Center21
已完成
2 期
Fenretinide In Treating Patients With Advanced or Metastatic Hormone-Refractory Prostate CancerProstate CancerNCT00077402Cancer Therapeutics Research Group50