Status and phase
Conditions
Treatments
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Histologically proven cutaneous melanoma, or clear cell sarcoma, which is considered as a subtype of melanoma.
Melanoma must be at one of the following AJCC 2002 stages:
Patients must be HLA-A1.
Melanoma must express the MAGE-3 gene, as determined by RT-PCR.
Presence of at least one measurable or non-measurable tumor lesion, excluding leptomeningeal metastasis.
Expected survival of at least 3 months.
Karnofsky performance scale ≥70 or WHO performance status of 0 or 1.
Within the last 4 weeks prior to study day 1, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which must be within the ranges specified:
Lab Parameter Range
Viral tests:
Age ≥ 18 years.
Able and willing to give valid written informed consent.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
1 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal