drugset / Trial / NCT00365937

Immunization of Disease-Free Melanoma Patients With Different HLA-A2 Peptides

NCT00365937

RandomizedParallel-groupOpen-labelTreatment

Summary

Open-label single center study. Patients will be divided in four groups of 7. Group 1: 8 melanoma-specific peptides in saline; Group 2: same mix of peptides + Montanide ISA51; Group 3: same mix of peptides + IMP321 500 µg; Group 4: same mix of peptides + IMP321 500 µg + Montanide ISA51. These vaccines will be administered every 3 weeks on 5 occasions by intradermal and superficial subcutaneous injections.

Timeline

Start
2006-08
Primary completion
2013-12-13
Completion
2013-12-13

Drugs

EvaluationDrugModalityDoseRoute
Subject IMP321 Protein / enzyme biologic 500 ug Intrathecal
Subject MAGE-1.A2 Peptide 300 ug Intravenous
Subject MAGE-10.A2 Peptide 300 ug Intravenous
Subject MAGE-3.A2 Peptide 300 ug Intravenous
Subject MAGE-4.A2 Peptide 300 ug Intravenous
Subject MAGE-C2.A2 Peptide 300 ug Intravenous
Subject NA17.A2 (GnTV) Peptide 300 ug Intravenous
Subject NY-ESO-1b.A2 Peptide 300 ug Intravenous
Subject Tyrosinase.A2 Peptide 300 ug Intravenous
Subject incomplete Freund's adjuvant Other / unclassified 1 ml Intrathecal

Indications