NCT00145145

Immunization With the MAGE-3.A1 Peptide Mixed With the Adjuvant CpG 7909 in Patients With Metastatic Melanoma

Phase I/II Study of Immunization With the MAGE-3.A1 Peptide Mixed With the Immunological Adjuvant CpG 7909 in Patients With Metastatic Melanoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Ludwig Institute for Cancer Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purposes of this study are to determine whether immunization with the MAGE-3.A1 peptide mixed with CpG 7909 results in a detectable immune response; to determine the safety of this vaccine and to document the tumor response to the vaccine.

Detailed description

Patients will be vaccinated every two weeks on six occasions. On each vaccination day, the MAGE-3.A1 peptide (300 µg) mixed with CpG 7909 (5 mg) will be administered twice intradermally (10% of the dose each) and twice subcutaneously (40% of the dose each) in the arms and thighs. Tumor staging will be performed before inclusion and at week 13. PBL collections will be performed before starting the treatment, and at weeks 3, 7 and 13. They will provide the T lymphocytes for the immunological analysis. Additional cycles of immunization will be proposed to patients without tumor progression requiring another treatment. A second cycle of 3 injections at 6-week intervals will be started at week 17 with the same vaccine, followed by a third cycle of 12 injections at 3-month intervals starting at month 11. At any time, progression of the disease necessitating any treatment not allowed during the study, will result in study withdrawal.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	MAGE-3.A1 peptide and CpG 7909

Timeline

• Start date: 2005-01-12
• Primary completion: 2005-04-07
• Completion: 2008-04-28
• First posted: 2005-09-05
• Last updated: 2022-10-07
• Results posted: 2021-07-21

Locations

2 sites across 1 country: Belgium