NCT00005038Unknown2 期
A Randomized Phase II Study to Evaluate the Efficacy of Combined Immunotherapy With Subcutaneous Interleukin-2 and Maxamine in Patients With Metastatic Renal Cell Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. Histamine dihydrochloride may prolong survival and improve quality of life in patients with metastatic kidney cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of interleukin-2 with or without histamine dihydrochloride in treating patients who have metastatic kidney cancer.
详细描述
OBJECTIVES:
- Determine the clinical efficacy and safety of subcutaneous (SC) histamine dihydrochloride given in conjunction with SC recombinant human interleukin-2 in patients with stage IV renal cell carcinoma in terms of survival at 1 year, objective tumor response rate, duration of response, and median survival.
OUTLINE: This is a randomized, open label study. Patients are randomized to receive interleukin-2 (IL-2) with or without histamine dihydrochloride.
- Arm I: Patients receive IL-2 subcutaneously (SC) once daily and histamine dihydrochloride SC twice daily on days 1-5 of weeks 1-3 followed by 2 weeks of rest.
- Arm II: Patients receive IL-2 as in arm I. Treatment continues for a minimum of 2 courses in both arms in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic renal cell carcinoma
- •Bidimensionally measurable disease
- •No clinical evidence of CNS metastases
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Hemoglobin greater than 10.0 g/dL
- •WBC greater than 3,000/mm3
- •Platelet count greater than 100,000/mm3
- •PTT normal
- •Bilirubin less than 1.25 times upper limit of normal (ULN)
- •Creatinine less than 1.5 times ULN
- •Cardiovascular:
- •No abnormal cardiac function by resting ECG
- •FEV and FVC at least 70% predicted
- •SaO2 at least 90% by pulse oximetry
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No clinically significant acute viral, bacterial, or fungal infection requiring specific therapy
- •No pheochromocytoma
- •No glaucoma
- •No other concurrent ongoing active malignancy except carcinoma in situ of the cervix or localized squamous or basal cell carcinoma of the skin
- •No serious recent nonmalignant medical complication that would preclude study therapy
- •No organ grafts except skin grafts, blood transfusions, or bone marrow or stem cell transplantation
- •No prior documented asthma or systemic allergic reaction within past 5 years
- •No history of seizures, CNS disorders, or psychiatric disability that would preclude study compliance
- •No medical, sociologic, or psychological impediment that would preclude study compliance
- •No active peptic or esophageal ulcer disease
- •No prior peptic or esophageal ulcer disease with history of bleeding
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior immunotherapy
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin)
- •No concurrent chemotherapy
- •Endocrine therapy:
- •At least 24 hours since prior steroids
- •No concurrent steroids including steroid therapy for documented adrenal failure or septic shock
- •Concurrent noncorticosteroid hormones for nonmalignancy conditions allowed
- •Radiotherapy:
- •At least 4 weeks since prior extensive radiotherapy
- •No concurrent radiotherapy to measurable malignant masses
- •Not specified
- •At least 24 hours since prior beta blockers or clonidine
- 另有 6 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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