We want to vaccine HLA-A2 patients who had a cutaneous melanoma at the following AJCC stage T3b-T4 N0 M0, Tx N1-3 M0, Tx Nx M0. Disease-free after surgery. With no previous immunizations with the same peptides is allowed if a CTL response was observed. And the patients must be met all the inclusion criteria.
Conditions
Interventions
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: MAGE-1.A2
Current Sponsor code: AC0511
Other descriptive name: KVLEYVIKV
Concentration unit: µg microgram(s)
Concentration t
Sponsors
Cliniques Universitaires Saint-Luc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. histologically proven cutaneous melanoma 2. Patient's melanoma must be in one of the following AJCC stages: only primary tumor (T3b-T4N0M0), regional lymph node metastatsis and/or in-transit metastasis, no distant metastasis (any T N1-N3M0) that has been removed; any distant metastatsis that has been removed (M1). 3. HLA-A2 positive. 4. Patients with previous regional metastatic disease must have one of their resected lesions analyzed by RT-PCR to determine expression of genes MAGE-1, MAGE-3, MAGE-4, MAGE-10, MAGE-C2, NA17, Tyrosinase or NY-ESO-1. However, expression of these genes by the tumor is not required. 5. Absence of detectable melanoma lesions. 6. WHO/ECOG performance status of 1 or less 7. Laboratory results with certain values. 8. Age more than 18 years 9. Able to give written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Clinically significant heart disease (NYHA Class III or IV) 2. Other serious illnesses, e.g. serious infections requiring antibiotics, bleeding disorders, a second active malignancy, except basal cell carcinoma or in situ carcinoma of the uterine cervix. 3. Active immunodeficiency disease or autoimmune disease. 4. Prositive serology for HIV or HCV. Serum hepatitis B antigen (HbS Ag) must be negative. 5. More than on line of previous chemotherapy, or immunotherapy for the melanoma. 6. Previous vaccination with one of the antigen present in the vaccine. 7. Treatment with steroids or major immunosuppressive drugs within 4 weeks before study entry. Topical or inhalated steroids are permitted. 8. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment. 9. Pregnancy or lactation. 10. Women of childbearing potential not using a medically acceptable means of contraception. 11. Psychiatric or addictive disorders that may compromise the ability to give informed consent. 12. Lack of availability of the patient for immunological and clinical follow-up assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To determine whether immunizaton with 8 HLA-A2 peptides alone or associated with different adjuvants (Montanide ISA 51VG or with IMP321 or the combination of these ywo), results in a detectable cytolytic T lymphocyte response in melanoma patients without detectable tumor. 2. Toxicity will be reported according to the Common Toxicity Criteria (CTC) Scale of the National Cancer Institute, version 3.0 (December 12th, 2003).;Secondary Objective: 1. If such a CTL response is dectected to analyze its kinetics. 2. If there is any improvement in disease-free survival. ;Primary end point(s): Assay of cellular immunity against the MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2, NA17.A2, Tyrosinase.A2 or NY-ESO-1.A2 antigens, by in vitro restimulation with the appropriate peptide, staining of responder lymphocytes with HLA/peptide tetramer, and analysis of positively stained CTL clones. Study the toxicity of vaccination of MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2, NA17.A2, Tyrosinase.A2 or NY-ESO-1.A2 peptides associated with the adjuvant IMP321 alone and with Montanide ISA 51VG. | — |
Countries
Belgium
Outcome results
None listed