A Phase 1 interventional study of Melan-A analog peptide in Melanoma, sponsored by University of Lausanne Hospitals. Suspended at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-09-12.
Sponsored by University of Lausanne Hospitals · Phase 1, Interventional, and Treatment
Patients with advanced stage melanoma who underwent vaccination with the Melan-A/MART-1 peptide and who display detectable levels of Melan-A specific CD8+ T cells in peripheral blood are eligible for this trial. After collecting and freezing of these tumor specific T cells via apheresis, patients undergo a single cycle of immunosuppressive chemotherapy. 3 days after, cells are reinfused and peptide vaccination continued. The aim of this immunotherapy protocol is to boost tumor specific T cells during the immune recovery period in order to reinforce the patients' immune response against the tumor.
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 6 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →University of Lausanne Hospitals is the lead sponsor of 118 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Toxicity and feasibility
Immunomonitoring of the immune reconstitution period
This study is suspended, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.
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University of Lausanne Hospitals