Phase I Study of in Vivo Expansion of Melan-A/MART-1 Antigen-Specific CD8 T Lymphocytes Following Transient Immunosuppression in Patients With Advanced Melanoma
Patients who have previously been vaccinated with Melan-A/MART-1 peptide are eligible. Whole
PBMC's containing Melan-A specific CD8+ lymphocytes are collected via lymphocytapheresis and
freezed. Lymphodepleting chemotherapy consists of 2 days of Busulfan 2mg/kg at days -7,-6,
followed by Fludarabine 30mg/m2 at days -5,-4,-3. At day 0, whole untreated PBMC's are
reinfused to the patient and vaccination with Melan-A analog peptide is restarted and
repeated every 4 weeks. Immunomonitoring with detailed FACS analysis using tetramers is
performed at day 0,8,15,30, and then monthly. The aim is to boost Melan-A specific CD8 T
cells in vivo during homeostatic proliferation after lymphodepletion and antigen driven
proliferation due to peptide vaccination.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity and feasibility
Verena Voelter, MD
Principal Investigator
Multidisciplinary Oncology Center, University of Lausanne Hospitals
Switzerland: Swissmedic
CePO-ITA-01
NCT00160992
July 2004
August 2005
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