Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Nantes University Hospital
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Treatment of Metastatic Melanoma With Autologous Melan-A/MART-1 Specific CTL Clones
