NCT00492440终止1 期
A Phase I Study of Subcutaneous "CYT 107" (Interleukin-7) in Refractory Metastatic Melanoma or Renal Cell Carcinoma
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Cytheris SA
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Safety of recombinant interleukin-7 (IL-7)
研究概览
简要总结
RATIONALE: Interleukin-7 may stimulate the white blood cells to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 in treating patients with metastatic melanoma or locally advanced or metastatic kidney cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety of recombinant interleukin-7 (IL-7) in patients with metastatic melanoma or locally advanced or metastatic renal cell carcinoma.
- Confirm the previously documented safety profile of non-glycosylated IL-7 in these patients.
- Determine the safety of higher doses of recombinant IL-7 in these patients.
- Determine the maximum tolerated dose of recombinant IL-7 in these patients.
- Determine the biologically active dose of recombinant IL-7 in these patients.
Secondary
- Determine the pharmacokinetics and pharmacodynamics of recombinant IL-7 in these patients.
- Compare the biological and clinical effects of recombinant IL-7 with non-glycosylated IL-7 in these patients.
- Determine the potential antitumor effect of recombinant IL-7 in these patients.
- Determine the dose and administration schedule of recombinant IL-7 in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 diagnosis of 1 of the following:
- •Metastatic disease
- •Renal cell carcinoma
- •Locally advanced and unresectable disease OR metastatic disease
- •Refractory to standard therapy OR ineligible to receive standard therapy
- •Measurable or evaluable disease
- •Previously received high-dose interleukin-2 OR have a contraindication for this treatment
- •No previously untreated or unstable brain metastases
- •No splenic metastasis
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy ≥ 3 months
- •Absolute neutrophil count > 1,000/mm^3
- •Platelet count > 100,000/mm^3
- •PT/PTT ≤ 1.5 times upper limit of normal (ULN)
- •Creatinine < 1.5 times ULN
- •AST and ALT < 2.5 times ULN
- •Conjugated (Direct) bilirubin ≤ 1.25 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •LVEF ≥ 45% by cardiac stress test (e.g., stress thallium, stress MUGA, dobutamine echocardiogram, or other stress test) for patients meeting any of the following criteria:
- •History of ECG abnormalities
- •Symptoms of cardiac ischemia
- •At least 50 years of age and over
- •Familial or personal history of heart failure
- •Previously treated with antimitotic agents susceptible to trigger heart failure
- •FEV_1 > 60% of predicted (for patients with a prolonged smoking history or symptoms of respiratory dysfunction)
- •No concurrent cognitive impairment or likelihood of developing cognitive impairment on study therapy
- •No concurrent splenomegaly or proliferative hematologic disease
- •No documented HIV positivity
- •No acute hepatitis A or hepatitis B or C
- •Positive hepatitis B serology indicative of previous immunization (i.e., HBs Ab positive and HBc Ab negative) allowed
- •Positive hepatitis C serology allowed provided HCV RNA load by PCR is negative
- •Resting blood pressure ≤ 140/90 mm Hg on standard antihypertensive therapy
- •Untreated hypertensive patients who received standard antihypertensive therapy allowed provided hypertension is well controlled
- •No QTc prolongation ≥ 470 msec
- •No prior history of cardiovascular disease, arrhythmias, or significant ECG abnormalities
- •No active infection requiring systemic treatment and/or hospitalization within the past 28 days
- •Patients who have completed therapy or are clinically stable on therapy, in the opinion of the investigator, are eligible
- •No history of autoimmune disease
- •No history of severe asthma
- •No history of medical or psychiatric disease that would preclude study treatment
- •No documented cirrhosis or documented acute hepatitis
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 2 weeks since prior systemic corticosteroid therapy
- •More than 4 weeks since prior and no other concurrent cytotoxic therapy, immunotherapy, biological agents (i.e., cytokines, growth factors, or monoclonal antibodies), or antitumor vaccines
- •More than 7 days since prior hepatotoxic drugs unless medically necessary
- 另有 10 项未显示
排除标准
- 未提供
研究组 & 干预措施
CYT107 (r-hIL-7)
Experimental
干预措施: flow cytometry (Other)
CYT107 (r-hIL-7)
Experimental
干预措施: immunoenzyme technique (Other)
CYT107 (r-hIL-7)
Experimental
干预措施: immunologic technique (Other)
CYT107 (r-hIL-7)
Experimental
干预措施: laboratory biomarker analysis (Other)
CYT107 (r-hIL-7)
Experimental
干预措施: pharmacological study (Other)
CYT107 (r-hIL-7)
Experimental
干预措施: gene expression analysis (Genetic)
CYT107 (r-hIL-7)
Experimental
干预措施: polymerase chain reaction (Genetic)
CYT107 (r-hIL-7)
Experimental
干预措施: protein expression analysis (Genetic)
CYT107 (r-hIL-7)
Experimental
干预措施: recombinant interleukin-7 (Biological)
结局指标
主要结局
Safety of recombinant interleukin-7 (IL-7)
次要结局
- Pharmacokinetics and pharmacodynamics of IL-7
- Comparison of the biological and clinical effects of recombinant IL-7 with non glycosylated IL-7
- Potential antitumor effect of recombinant IL-7
- Dose and administration schedule of recombinant IL-7
研究者
研究点 (1)
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