Treatment of Metastatic Melanoma With Autologous Melan-A/MART-1 Specific CTL Clones
Inclusion Criteria:
- HLA-A2 melanoma patients with :
- either loco-regional or lymph node metastasis
- transit nodules not surgically resectable
- measurable cutaneous or visceral metastasis
- 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:
- Cardio-vascular pathologies, evoluting and uncontrolled, (severe HTA), cardiac
deficiency, severe angor, severe arrhythmia.
- Infectious pathologies evoluting and requiring antibiotherapy.
- Patients HIV+.
- Transplanted patients or patients suffering from severe auto-immune disease.
- Psychiatric troubles that do not allow the protocol follow-up.
- Pregnant or breast-feeding women.
- No contraception.