EUCTR2010-021885-31-NL进行中（未招募）1 期
Randomized Phase II Study Using a Non-myeloablative Lymphocyte Depleting Regimen of Chemotherapy Followed by Infusion of Tumor Infiltrating Lymphocytes and Interleukin-2 in Metastatic Melanoma’ - Lymphodepletion, TIL and Interleukin 2
KI-AV0 个研究点开始时间: 2010年12月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients must have metastatic melanoma with a resectable metastatic lesion of sufficient size (= 3 cm) and must be willing to undergo such a resection for experimental purposes.
- •Patients must be = 18 years of age and must have measurable metastatic melanoma (in addition to the resected lesion).
- •Patients must have a clinical performance status of ECOG 0 or 1.
- •Patients of both genders must be willing to practice a highly effective method of birth control during treatment and for four months after receiving the preparative regimen.
- •Patients must be able to understand and sign the Informed Consent document.
- •Laboratory Parameters (Note: patients may undergo resection with lab values outside of the parameters listed below if it is anticipated that the resection will correct the abnormality).
- •Hematology:
- •Absolute neutrophil count greater than 1.5 x 109/L without support of filgrastim.
- •Platelet count greater than 100 x 109/L.
- •Hemoglobin greater than 5 mmol/L.
- •Serum ALAT/ASAT less than 3 times the upper limit of normal, unless patients have liver metastases (< 5 times ULN).
- •Serum creatinine clearance 50 ml/min or higher.
- •Total bilirubin less than or equal to 20 micromol/L, except in patients with Gilbert’s Syndrome who must have a total bilirubin less than 50 micromol/L.
- •Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.)
- •Seronegative for hepatitis B antigen, and hepatitis C antibody.
- •Seronegative for lues.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Life expectancy of less than three months.
- •Patients with metastatic ocular or mucosal melanoma.
- •Requirement for systemic steroid therapy.
- •Patients who have a history of more than two CNS metastases.
- •Patients who have any CNS lesion that is symptomatic, greater than 1 cm in diameter or shows significant surrounding edema on MRI scan will not be eligible until they have been treated and demonstrated no clinical or radiologic CNS progression for at least 2 months.
- •Any immunosuppressive chemotherapy or systemic steroid therapy within the last 3 weeks.
- •The following patients will be excluded because of inability to receive high dose interleukin-2:
- •History of coronary revascularization
- •Documented LVEF of less than 45% in patients with:
- •Clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, 2° or 3° heart block
- •Documented FEV1 less than or equal to 60% predicted for patients with:
- •A prolonged history of cigarette smoking (greater than 20 pack/year within the past 2 years)
- •Symptoms of respiratory distress
- •All patients’ toxicities due to prior non-systemic treatment must have recovered to a grade 1 or less. Patients may have undergone minor surgical procedures or focal palliative radiotherapy (to non-target lesions) within the past 4 weeks, as long as all toxicities have recovered to grade 1 or less.
- •Women who are pregnant or breastfeeding, because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
- •Any active systemic infections, coagulation disorders or other active major medical illnesses, such as active autoimmune disease requiring anti-TNF treatment.
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