Treatment of Metastatic Melanoma With Autologous Melan-A/MART-1 Specific CTL Clones
Treatment of Metastatic Melanoma With Autologous Melan-A/MART-1 Specific CTL Clones
Most of HLA-A2 melanomas express Melan-A/MART-1 antigen and are recognized by tumor reactive Melan-A specific T lymphocytes. By using blood samples from HLA-A2 melanoma patients (stage III and IV), our goal is to produce a tumor reactive Melan-A specific T cell clones and to conduct a phase I-II clinical trial, based on the infusion of several millions to several billions of these lymphocytes to the patient, in order to induce passive immunity against this antigen. Production of the clones will be performed in the Unit for Cellular and Gene Therapy from Nantes University Hospital. Therapeutic response, safety treatment but also localization and survival of infused T cell clones will be assessed. This approach is expected to precise the ability of the clones to migrate within the tumor and to transfer specific immunity.
Inclusion Criteria:
HLA-A2 melanoma patients with :
Patients' tumor express Melan-A/MART-1 antigen.
No chemotherapy treatment (except for Deticene used before the first T cell clones infusion) or radiotherapy or immunotherapy in the last 4 weeks before infusion.
No other melanoma treatment during the protocol.
Life expectancy should be greater than 6 months.
General state with Karnowsky greater than 80, ECOG = 0, 1 or 2.
Patient should be negative for HIV and B and C hepatitis.
Biological parameters at the beginning of the study: leucocytes ³ 2000 elements per mm3, hemoglobin ³ 10.5g/dl, platelets ³ 100 000 per mm3, phosphatases alcalines transaminases £ 1 time 1/2 compared to the normal.
Signed informed consent
Exclusion Criteria: