NCT01082887终止1 期
A Phase I/II Study of Immunotherapy With TIL (Tumor Infiltrating Lymphocytes) in Combination With Intra-tumoral Injections of Interferon Gamma-adenovirus (Ad-IFNg) in Patients With Stage IIIc or Stage IV Metastatic Melanoma (AJCC)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Clinical and biological toxicity of combined treatment TIL, IL2 et Ad-INFg
研究概览
简要总结
The main objective of this study is to evaluate the clinical and biologic toxicity of cell therapy by adoptive transfer of TIL in combination with intra-tumoral injections of Ad-INFg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥ 18 and ≤ 75 years of age
- •Patients must have signed informed consent
- •A negative pregnancy test for women with childbearing potential
- •Patients with stage IIIc/IV metastatic melanoma (AJCC 6th edition) with nodal relapse, in transit metastasis, unresectable cutaneous metastases, visceral metastases except bone and brain metastases
- •Presence of at least one lesion accessible for intra-tumoral injections of Ad-IFNg
- •A negative brain scan, eliminating any brain metastases
- •ECOG performance status of 0-2
- •Adequate bone-marrow reserve, renal function and hepatic function as assessed by standard laboratory criteria
- •Subjects affiliated to an appropriate social security system
- •Inclusion Criteria:
- •Negative viral serology (HIV ½, p24 Ag, HTLV 1 / 2, B and C hepatitis)
排除标准
- •For female : the patient is pregnant or lactating or not using contraception and proved by a negative pregnancy test
- •Positive viral serology for HIV ½, p24 Ag, HTLV 1 / 2 or B and C hepatitis
- •History or current manifestations of severe progressive heart disease (congestive heart failure, coronary artery disease, uncontrolled arterial hypertension, serious rhythm disorders or ECG signs of previous myocardial infarction)
- •Any serious illness, acute or chronic, e.g. active infection requiring antibiotics, bleeding disorders or any other condition that requires concomitant medications not allowed during this study
- •Presence of a second active cancer except in situ cervical cancer or skin carcinoma
- •Intercurrent disease requiring a corticosteroid treatment or a treatment with interferon-α
- •Any autoimmune disease including active diabetes mellitus or immunodeficiency. Vitiligo in not an exclusion criteria
- •Uncontrolled thyroid dysfunction
- •Concurrently participation in a biomedical research (drug or radiotherapy) within the month preceding inclusion
- •Metastatic lymph node stage alone with an indication of lymphadenectomy
- •Brain or bone metastases discovered by radiological examination during the inclusion assessment
- •Surgically resectable metastases
- •Ocular melanoma
- •More than one line of chemotherapy for treatment of melanoma
- •Chemotherapy, immunotherapy or radiotherapy within 4 weeks before baseline (6 weeks for nitroso-ureas and mitomycin C)
- •Contraindication for the use of vasopressor agents
- •Treatment with molecules in pre-marketing development or whose development is finished less than 4 weeks
结局指标
主要结局
Clinical and biological toxicity of combined treatment TIL, IL2 et Ad-INFg
时间窗: 12 months
The evaluation of clinical and biological toxicity of combined treatment including infusion of TIL associated with subcutaneous injections of low-doses of IL-2 and intra-tumoral injections of Ad-IFNg will be performed according to clinical and biological criteria defined by NCI (Common Toxicity Criteria - version 3.0, August 2006).
次要结局
- Tumoral response(12 months)
- Objective response rate(12 months)
- Overall survival(12 months)
- Immunological response(12 months)
- Progression-free survival(12 months)
研究者
研究点 (2)
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