NCT00276835已完成1 期
A Pilot Study of the Effect of Genistein in Combination With High-Dose Interleukin-2 on Cell Expansion and Gene Expression in Patients With Metastatic Melanoma or Renal Cell Carcinoma
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Differences in peak and duration of the expansion of circulating CD4+, CD8+, and CD4+, CD25+, and CD56+ cells (dim and bright)
研究概览
简要总结
RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Interleukin-2 may stimulate the white blood cells, including natural killer cells, to kill melanoma or kidney cancer cells. Giving genistein together with interleukin-2 may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving genistein together with interleukin-2 works in treating patients with metastatic melanoma or kidney cancer.
详细描述
OBJECTIVES:
Primary
- Measure the differences in peak and duration of the expansion of circulating CD4-positive, CD8-positive, and CD4-, CD25-, and CD56-positive cells (dim and bright) at different time points during therapy with interleukin-2 (IL-2) alone and plus genistein in patients with metastatic malignant melanoma or renal clear cell carcinoma.
Secondary
- Evaluate the differences in peripheral blood mononuclear cell gene expression following high-dose IL-2 with and without genistein and compare to baseline.
- Determine the overall response rate (partial and complete) in patients treated with these regimens.
- Determine the safety and toxic effects of these regimens in these patients.
- Determine the time to progression in patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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:
- •Documented histologically confirmed malignant melanoma or renal clear cell carcinoma
- •Metastatic disease
- •At least 1 measurable lesion that can be accurately measured in at least one dimension with longest diameter > 20 mm using conventional techniques OR > 10 mm with spiral CT scan
- •If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology
- •Clinical lesions will only be considered measurable when they are superficial (e.g., skin nodules or palpable lymph nodes)
- •The following are considered non-measurable lesions:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural/pericardial effusion
- •Inflammatory breast disease
- •Lymphangitis cutis/pulmonis
- •Cystic lesions
- •Abdominal masses that are not confirmed and followed by imaging techniques
- •No CNS metastases by CT scan or MRI
- •PATIENT CHARACTERISTICS:
- •ECOG performance status < 2
- •Life expectancy ≥ 4 months
- •Serum creatinine < 2.0 mg/dL OR creatinine clearance > 50 mL/min
- •Bilirubin normal
- •Platelets > 100,000/mm³
- •WBC > 3,500/mm³
- •No evidence of congestive heart failure
- •No symptom of coronary artery disease
- •No serious cardiac arrhythmias
- •A pretreatment cardiac stress test must be performed within 42 days of IL-2 treatment if any cardiac symptoms present (patients with documented ischemia on the pretreatment cardiac stress test will be excluded from the study)
- •Adequate pulmonary reserve
- •FEV_1 > 75% of predicted
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •Negative pregnancy test
- •No known HIV-positive patients
- •No evidence of active infection requiring antibiotic therapy
- •No contraindication to treatment with pressor agents
- •No significant medical disease which, in the opinion of the investigator, may interfere with completion of the study
- •No history of another malignancy other than basal cell skin cancer within 5 years
- •PRIOR CONCURRENT THERAPY:
- •Recovered from all toxic effects of prior therapy
- •No radiotherapy, chemotherapy, or immunotherapy in the 4 weeks prior to the first dose of the study treatment
- •No systemic corticosteroids in the 4 weeks prior to treatment
- •No previous investigational agent within 4 weeks prior to the start of the study
- •No prior interleukin-2 therapy
- •No organ allografts allowed
- •No concurrent radiotherapy, chemotherapy, or immunotherapy
- •No concurrent corticosteroids
- •No concurrent chronic medication for asthma
排除标准
- 未提供
研究组 & 干预措施
Genistein and Interleukin-2
Experimental
干预措施: High-dose interleukin-2 (Biological)
Genistein and Interleukin-2
Experimental
干预措施: genistein (Dietary Supplement)
结局指标
主要结局
Differences in peak and duration of the expansion of circulating CD4+, CD8+, and CD4+, CD25+, and CD56+ cells (dim and bright)
时间窗: Days 1, 8, 10, 15, 22, and 24 of treatment
次要结局
- Circulating plasma levels of TGF-beta(Prior to and at end of treatment)
研究者
Timothy Kuzel
Timothy Kuzel, MD
Northwestern University
研究点 (1)
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