drugset / Trial / NCT00365937
Immunization of Disease-Free Melanoma Patients With Different HLA-A2 Peptides
Phase 1/2
Terminated
19 enrolled
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Immutep S.A.S. · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |