Phase I/II study of peptide vaccination associated with GM-CT-01, a galactomannan oligomer that inhibits galestin-3, in patients with advanced metastatic melanoma - Peptide vaccinations plus GM-CT-01 in melanoma

Centre du Cancer des Cliniques Universitaires Saint-Luc0 个研究点目标入组 6 人开始时间: 2011年9月20日最近更新: 2022年3月28日

适应症

试验速览

暂无简介。

•1. Patients with histologically proven cutaneous melanoma at one of the following AJCC stages:
•- Regional metastatic disease (any T; N2c or N3; M0), not amenable to curative treatment by surgery or isolated limb perfusion.
•- Distant metastatic disease (any T; any N; M1a, M1b or M1c*).
•*except uncontrolled brain metastasis and except LDH >1,5ULN
•2. HLA-A1 or HLA-A2 (by serology or molecular biology).
•3. At least one of the two following conditions:
•MAGE-3 gene expression by the tumor if patient is HLA-A1
•NA17 gene expression by the tumor if patient is HLA-A2 (determined by RT-PCR analysis).
•4. Measurable Disease.
•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 31
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•1. Uncontrolled brain or central nervous system metastasis.
•2. 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.
•3. Previous chemotherapy, radiotherapy, corticotherapy, or other immune suppressive therapy within 4 weeks from inclusion.

发起方

Centre du Cancer des Cliniques Universitaires Saint-Luc