drugset / Trial / NCT00145158
Immunization With 8 Peptides Mixed With CpG 7909 or Montanide ISA51 in Patients With Metastatic Cutaneous Melanoma
Non-randomizedSequentialOpen-labelTreatment
Summary
The purposes of this study are to describe the immune response to individual peptides after immunization with a combination of 8 peptides and CpG 7909 or Montanide ISA51; to determine the safety of the vaccines and; to document the tumor response in patients receiving the vaccines.
Timeline
- Start
- 2005-01
- Primary completion
- 2007-11-30
- Completion
- 2009-03-12
Publications
- Background Marchand M, van Baren N, Weynants P, Brichard V, Dreno B, Tessier MH, Rankin E, Parmiani G, Arienti F, Humblet Y, Bourlond A, Vanwijck R, Lienard D, Beauduin M, Dietrich PY, Russo V, Kerger J, Masucci G, Jager E, De Greve J, Atzpodien J, Brasseur F, Coulie PG, van der Bruggen P, Boon T. Tumor regressions observed in patients with metastatic melanoma treated with an antigenic peptide encoded by gene MAGE-3 and presented by HLA-A1. Int J Cancer. 1999 Jan 18;80(2):219-30. doi: 10.1002/(sici)1097-0215(19990118)80:23.0.co;2-s.
- Background Germeau C, Ma W, Schiavetti F, Lurquin C, Henry E, Vigneron N, Brasseur F, Lethe B, De Plaen E, Velu T, Boon T, Coulie PG. High frequency of antitumor T cells in the blood of melanoma patients before and after vaccination with tumor antigens. J Exp Med. 2005 Jan 17;201(2):241-8. doi: 10.1084/jem.20041379.
- Background Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MAGE-1.A2 | Peptide | 300 ug | — |
| Subject | MAGE-10.A2 | Peptide | 150 ug | — |
| Subject | MAGE-3.A2 | Peptide | 300 ug | — |
| Subject | MAGE-4.A2 | Peptide | 300 ug | — |
| Subject | MAGE-C2.A2 | Peptide | 300 ug | — |
| Subject | NA17.A2 | Peptide | 300 ug | Intramuscular |
| Subject | NY-ESO-1.A2 | Unknown | 300 ug | Subcutaneous |
| Subject | Tyrosinase.A2 | Peptide | 300 ug | Subcutaneous |
| Subject | agatolimod | Oligonucleotide (other) | 4 mg | — |
| Subject | incomplete Freund's adjuvant | Other / unclassified | 0.5 ml | — |