NCT00045279已完成2 期
Phase II Trial of PEG-Intron in Patients With Advanced Renal Cell Carcinoma
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: PEG-interferon alfa-2b may stop the growth of kidney cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating patients who have metastatic kidney cancer.
详细描述
OBJECTIVES:
- Determine the efficacy of PEG-interferon alfa-2b in patients with metastatic renal cell carcinoma.
- Determine the time to disease progression in patients treated with this drug.
- Determine the safety of this drug in these patients.
- Determine the quality of life of patients treated with this drug.
- Determine the effect of this drug on biological surrogates of antitumor activity (basic fibroblast growth factor, vascular endothelial growth factor, and interleukin-6 serum levels) in these patients.
OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at 2 weeks and at 2, 4, 8, and 12 months after initiation of study therapy, and then at completion of study therapy.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 15 months.
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 confirmed renal cell carcinoma
- •Metastatic disease
- •No prior therapy for advanced disease
- •Tumor sample available for molecular analysis with prior registration on MSKCC IRB # 89-076
- •Bidimensionally measurable disease
- •No brain metastases unless completely resected and without evidence of recurrence for at least six months
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC at least 3,000/mm3
- •Platelet count at least 100,000/mm3
- •Bilirubin no greater than 1.5 mg/dL
- •SGOT no greater than 2.5 times upper limit of normal (unless due to hepatic metastases)
- •Hepatitis B surface antigen negative
- •Hepatitis C negative
- •Creatinine no greater than 2 mg/dL
- •Cardiovascular
- •No severe cardiac disease
- •No New York Heart Association class III or IV cardiac disease
- •No myocardial infarction within the past 12 months
- •No ventricular tachyarrhythmias requiring ongoing treatment
- •No unstable angina
- •No severe asthma requiring chronic systemic steroids
- •HIV negative
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No malignancy within the past 2 years except basal cell or squamous cell skin cancer, superficial bladder cancer, or localized prostate cancer
- •Patients who have undergone potentially curative therapy and have been deemed to be at low risk for recurrence are eligible
- •No medically significant psychiatric disease (e.g., endogenous depression, psychosis, or bipolar disease) requiring hospitalization
- •No prior or active autoimmune disease
- •Medically controlled diabetes or thyroid dysfunction allowed
- •No clinically significant acute viral or bacterial infection that requires specific therapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior interleukin-2
- •No prior interferon alfa
- •No concurrent cytokines or biological response modifiers except epoetin alfa in the case of hematologic compromise
- •No concurrent tumor vaccines
- •No concurrent monoclonal antibodies
- •No concurrent bone marrow/stem cell transplantation
- •Chemotherapy
- •No concurrent cytotoxic agents
- •Endocrine therapy
- •No concurrent high-dose systemic steroids
- •Concurrent low-dose corticosteroids (e.g., asthma inhalers, topical creams, or intra-articular injections) allowed
- 另有 10 项未显示
排除标准
- 未提供
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
PEG-Interferon Alfa-2b in Treating Patients With Stage IV MelanomaMelanoma (Skin)NCT00049530Eastern Cooperative Oncology Group32
终止
不适用
Study of Pegylated Interferon-Alfa 2b in Combination With PUVA Therapy In CTCLLymphomaNCT00724061Northwestern University7
已完成
2 期
Tretinoin Plus Interferon Alfa in Treating Patients With Metastatic Kidney CancerKidney CancerNCT00003656Weill Medical College of Cornell University26
已完成
2 期
Interferon Alfa (IFN-Alpha-1b) in Renal Cancer With Metastatic Kidney CancerKidney CancerNCT00278174Case Comprehensive Cancer Center7
已完成
2 期
SU5416 and Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Kidney CancerKidney CancerNCT00006384City of Hope Medical Center