Phase I/II study of peptide vaccination associated with tumoral immunomodulation with proinflammatory cytokines and imiquimod in patients with advanced metastatic melanoma

Centre du Cancer0 个研究点目标入组 3 人开始时间: 2010年6月9日最近更新: 2022年3月28日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 3

研究概览入排标准研究者记录与标识符相似试验

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 with histologically proven cutaneous melanoma at one of the following AJCC stages (see appendix A) :
•- Regional metastatic disease (any T; N2c or N3; M0).
•- Distant metastatic disease (any T; any N; M1a, M1b or M1c*).
•*except except uncontrolled and brain metastasis.
•HLA-A1 or HLA-A2 (by serology or molecular biology).
•MAGE-3 gene expression by the tumour if patient is HLA-A1 and/or NA17 gene expression by the tumour if patient is HLA-A2 (determined by RT-PCR analysis).
•Patients must have at least two metastases at study entry, including one cutaneous metastasis (equal to or greater than 5 mm in its longest diameter), and one measurable metastasis, as defined by RECIST (see Appendix H and section 3.1 for RECIST v1.1 guidelines, and related deviations).
•Age = 18 years.
•Karnosky Performance status (KPS) =70 or WHO performance status of 0 or 1 (see Appendix B).
•Expected survival of at least 6 months.
•Normal laboratory values :
•Platelet count =100x103/µL
•Leucocyte count = 3x103/µL
•Hemoglobin = 9 g/dL
•ASAT and ALAT = 2xUNL
•Serum creatinine =1.5xUNL
•Total bilirubin = 1.5xUNL
•LDH = 1.5xUNL
•Viral serology : negative antibodies for HCV & HIV; negative antigens for HBV.
•Patient should agree to perform biopsies and blood collections for translational research.
•Signed informed consent from the patient or legal representative must be obtained.
•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

•Uncontrolled brain or central nervous system metastases.
•Previous treatment for the melanoma within 6 weeks from inclusion, with any reagent known to modulate the immune system such as a cancer vaccine, interferon-alpha, interleukins or anti-CTLA-4 antibodies.
•Previous chemotherapy, radiotherapy, corticotherapy, or other immune suppressive therapy within 4 weeks from inclusion.
•Clinically significant cardiovascular disease (including cardiac insufficiency NYHA grade III and IV, unstable angina, arrythmia, myocardial infarction, symptomatic congestive heart failure) in the past 12 months before enrollment.
•Other serious acute or chronic illnesses, e.g. active infections requiring antibiotics, bleeding disorders or other conditions requiring concurrent medications not allowed during this study.
•Other malignancy within 3 years prior to entry in the study, except for treated non-melanoma skin cancer and in situ cervical carcinoma.
•Active immunodeficiency disease or autoimmune disease (Vitiligo is not an exclusion criterion).
•Lack of availability for immunological and clinical follow-up assessments.
•Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
•Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment.
•Subject (male or female) not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months after the end of treatment.

研究者

发起方

Centre du Cancer

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