EUCTR2015-000556-14-IT进行中（未招募）1 期
Vaccination with dendritic cells pulsed with autologous tumor homogenate in combination with HD-IL2 and immunomodulating radiotherapy in metastatic RCC: a phase II trial (RENALVax-2) - RENALVax-2
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS0 个研究点目标入组 37 人开始时间: 2017年12月15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
- 入组人数
- 37
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
- •1. Signed Written Informed Consent: patients must be willing and able to give written informed consent, that has to be given before starting of screening procedures.
- •2. Availability of autologous tumor tissue fulfilling acceptance criteria prescribed by the Product Specification File”.
- •3. Patients must have histologically or cytologically confirmed RCC (all histology types except for urothelial cancer);
- •4. Patients must have stage IV disease in progression after at least 1 TKI and/or antiangiogenetic and/or mTOR inhibitors therapy
- •(patients must have finished prior treatments at least 4 weeks before the first IL2 dose)
- •5. Patients must have at least one measurable lesion, according to the irRC response criteria (see section 8 ), after asportation of tumor tissue for vaccine preparation. The tumor lesions that will be irradiated are excluded for response evaluation.
- •6. Life expectancy of greater than 3 months.
- •7. ECOG performance status 0-1
- •8. Patients must have organ and marrow function as defined below:
- •-leukocytes >4000/L
- •-absolute neutrophil count>1,500/L
- •-platelets >100,000/L
- •-total bilirubin within normal institutional limits (nil)
- •- AST(SGOT)/ALT(SGPT)<2.5 X institutional upper limit of normal
- •-creatinine< 1.5 mg/dl
- •- haemoglobin >8.0 gm/dl
- •- hematocrit <30%
- •9. ECG and echocardiography within normal institutional limits
- •10. Pulmonary function tests within normal institutional limits
- •11. No contraindication for the use of vasopressor agents
- •12. Negative screening tests for HIV, HBV HCV and syphilis not older than 30 days before performing any of the GMP-regulated activities required
- •13. Men and women aged > 18 years.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1.Patients who have positive tests to HCV, HBV, HIV, or syphilis (specific blood testing must be performed within 30 days before
- •any GMP-regulated activity).
- •2.Patients who did not have prior lines of systemic therapy for advanced disease.
- •3.Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- •4.Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure,
- •unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study
- •requirements (on physician’s judgment).
- •5.Other known malignant neoplastic diseases in the patient’s medical history with a disease-free interval of less than 3 years
- •(except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix);
- •6.Patients who have had chemotherapy or radiotherapy or immunotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin
- •C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4
- •weeks earlier.
- •7.Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because
- •they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- •8.History of allergic reactions attributed to compounds of similar chemical or biologic composition to IL-2 or other agents used in
- •9.Any autoimmune disease which could be exacerbated by IL-2
- •10.A medical illness requiring chronic treatments with corticosteroids or other immunosuppressive agents
- •11.A history of significant cardiovascular disease, including myocardial infarction, congestive heart failure, primary cardiac
- •arrhythmias, angina pectoris or cerebrovascular accident
- •12.HIV-positivity, whether or not symptomatic
- •13.Any contraindication to undergo leukapheresis as evaluated by transfusionist (e.g. severe anemia, piastrinopenia, oral
- •anticoagulant therapy) or to undergo surgery.
研究者
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