High-Dose Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer or Melanoma
Treatment of Metastatic Renal Cell Carcinoma and Melanoma With Subsequential High-Dose Subcutaneous Interferon Alfa-2b and High-Dose Bolus and Continuous Intravenous Interleukin-2
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer or melanoma cells.
PURPOSE: Phase II trial to study the effectiveness of high-dose interferon alfa and interleukin-2 in treating patients with metastatic kidney cancer or melanoma.
研究概览
详细说明
OBJECTIVES: I. Determine the safety, efficacy, and antitumor activity of high dose interferon alfa-2b and interleukin-2 in patients with metastatic renal cell carcinoma or melanoma. II. Determine the toxic effects of interferon alfa-2b and interleukin-2 in these patients.
OUTLINE: This is an open label study. Patients receive subcutaneous interferon alfa-2b on days 1-4. Patients are hospitalized and receive bolus infusions of interleukin-2 (IL-2) followed by a continuous infusion on days 5-7. Patients are observed at least 12 hours following IL-2 treatment. Treatment is repeated every 4 weeks until disease progression or up to a maximum of six cycles. Patients are followed every 2 months for one year, then for survival.
PROJECTED ACCRUAL: If at least 1 response is seen in the first 14 patients in each group, a maximum of 40 patients per group will be accrued.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
California
-
Newport Beach、California、美国、92658
- Hoag Memorial Hospital Presbyterian
-
-
Indiana
-
Bloomington、Indiana、美国、47402
- Bloomington Hospital
-
-
Tennessee
-
Knoxville、Tennessee、美国、37901
- Baptist Regional Cancer Center - Knoxville
-
-
Texas
-
Bryan、Texas、美国、77802
- St. Joseph Regional Cancer Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS: Histologically proven metastatic renal cell carcinoma or melanoma Measurable or evaluable disease No active brain metastases Previously treated CNS metastases responding to therapy are eligible, but CNS cannot be the site of evaluable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: ECOG 0-2 Life Expectancy: Not specified Hematopoietic: Hematocrit at least 25 WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 PT and PTT within normal limits Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No myocardial infarction within 6 months No medication for congestive heart failure or cardiac arrhythmias No hypertension (unless blood pressure is stable off medication) Pulmonary: Must have reasonable respiratory reserves and not require supplemental oxygen No dyspnea at rest Oxygen saturation must be greater than 90% for patients with risk of respiratory symptoms Other: Not HIV positive Not positive for hepatitis B antigen No chronic underlying immunodeficiency No concurrent active infection requiring antibiotic therapy Not pregnant or nursing No concurrent serious illness No family history of malignant hyperthermia No hypersensitivity to interferon alfa-2b and interleukin-2
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior interleukin-2 and interferon alfa-2b in combination therapy Chemotherapy: No prior systemic chemotherapy within 4 weeks of study and recovered Endocrine therapy: No concurrent corticosteroid therapy Radiotherapy: No prior radiotherapy within 4 weeks of interleukin-2 therapy No prior stereotactic radiosurgery or gamma knife therapy within 1 week of interleukin-2 therapy Surgery: No prior organ allograft transplantation Must be recovered from prior surgery Other: No concurrent cyclosporin therapy No concurrent treatment with other anticancer agents
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
合作者和调查者
调查人员
- 学习椅:Robert O. Dillman, MD, FACP、Cancer Biotherapy Research Group
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.