SNPMiner Trials (Home Page)
Report for Clinical Trial NCT00559026
Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene
This phase I/II study is directed at evaluating safety and immunogenicity of a melanoma
peptide vaccine in combination or not with Dacarbazine administration in melanoma patients
Description: i.d. injections of Melan-A: 26-35 (A27L) and gp100: 209-217 (210M) peptides (250 µg each) formulated in Montanide ISA-51 plus s.c. injection of 3MU IFN-α, as an adjuvant on day 1 and 8 every 21 days for a total of 5 courses
Name: Melan-A plus Dacarbazine
Description: Dacarbazine plus vaccine: the vaccination schedule as in arm 1 was combined with DTIC (800 mg/mq i.v.) administered one day before each vaccine administration according to the standard treatment.
Primary Outcomes Measure: Assessment of safety by evaluating local and systemic adverse reactions during the trial. Assessment of the vaccine-specific cellular immune responses Time: one year
Secondary Outcomes Measure: Assessment of relapse-free survival and overall survival calculated from the time of the first chemotherapy/vaccine injection. Evaluation by microarray analysis of the gene expression profiles of patients PBMC 24 h after DTIC administration. Time: two years
Single Group Assignment
There is one SNP
injections of Melan-A: 26-35 (A27L) and gp100:
209-217 (210M) peptides (250 µg each) formulated in Montanide ISA-51 plus s.c. --- A27L ---