Status:
COMPLETED
Treatment of Metastatic Melanoma With Autologous Melan-A/MART-1 Specific CTL Clones
Lead Sponsor:
Nantes University Hospital
Conditions:
Immunotherapy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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), ou...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00720031
Start Date
November 1 2000
End Date
May 1 2008
Last Update
July 24 2008
Active Locations (1)
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1
Nantes University Hopspital
Nantes, Pays de la Loire Region, France, 44093