Phase I/II Study of Subcutaneous Administration of Pegylated-Interferon Alpha-2A (RO 25-8310) in Previously Untreated Patients With Locally Advanced or Metastatic Renal Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 4
研究概览
简要总结
RATIONALE: Interferon alfa may interfere with the growth of cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of interferon alfa in treating patients with advanced kidney cancer.
详细描述
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of pegylated-interferon alfa-2a in patients with advanced or metastatic renal cell carcinoma. II. Evaluate the safety profile of the MTD in this patient population. III. Determine the objective response rate, time to response, duration of response, time to progression, and survival rate in this patient population.
OUTLINE: This is a dose escalation, open label, multicenter study. Patients receive pegylated-interferon alfa-2a (PEG-IFN) subcutaneously once a week for 24 weeks. Dose escalation of PEG-IFN continues 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. After the MTD of PEG-IFN is determined, additional patients are treated at this dose level. These patients may continue treatment after the first 24 weeks for up to 1 year, in the absence of disease progression. Patients are followed for 4 weeks.
PROJECTED ACCRUAL: A total of 46-58 patients will be accrued for this study within 9 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 advanced or metastatic renal cell carcinoma Bidimensionally measurable lesions that have not been irradiated Minimum indicator lesion size: Liver, soft tissue, or other masses - one diameter at least 20 mm (evaluable only radiographically) Lung - one diameter at least 10 mm by x-ray or CT scan Skin lesions and lymph nodes - one diameter at least 10 mm by clinical measurement No clinical or radiologic evidence of CNS metastases
- •PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: WBC at least 3000/mm3 Neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL (red cell transfusions allowed) Hepatic: Bilirubin no greater than 1.5 times the upper limit of normal (ULN) (except for patients with Gilbert's syndrome) ALT and/or AST no greater than 2.5 times ULN (no greater than 4 times ULN with liver metastases) Alkaline phosphatase no greater than 2.5 times ULN (no greater than 4 times ULN with liver metastases) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No history of severe cardiac disease: New York Heart Association class II (if not due to cancer), III, or IV Myocardial infarction within the past 6 months Ventricular tachyarrhythmias requiring ongoing treatment Unstable angina Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior or concurrent malignancy except basal cell carcinoma of the skin, carcinoma in situ of the cervix, or any other malignancy from which the patient has been disease free for at least 2 years No history of medically significant psychiatric disease, especially depression No history or evidence of retinopathy No seizure disorders
- •PRIOR CONCURRENT THERAPY: Biologic therapy: No prior or concurrent immunotherapy, biologic response modifiers, cytokines, monoclonal antibodies, antitumor vaccines, or any other systemic therapy Chemotherapy: No prior or concurrent chemotherapy Endocrine therapy: No prior or concurrent hormone therapy Hormone replacement after adrenalectomy is allowed Radiotherapy: Prior radiotherapy allowed No concurrent radiotherapy Surgery: Prior nephrectomy allowed Other: No other concurrent investigational drugs No concurrent anticonvulsant therapy
排除标准
- 未提供