Immunization of disease-free melanoma patients with different HLA-A2 peptides.

Cliniques Universitaires Saint-Luc0 sites28 target enrollmentFebruary 22, 2006

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: 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.
Sponsor: Cliniques Universitaires Saint-Luc
Enrollment: 28
Status: Active, not recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

February 22, 2006

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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.