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Randomized Phase II Trial of Adjuvant WT-1 Analog Peptide Vaccine in Patients with Malignant Pleural Mesothelioma after Completion of Multimodality Therapy
Annual rept. 15 Aug 2011-14 Aug 2012
SLOAN-KETTERING INST FOR CANCER RESEARCH NEW YORK
Pagination or Media Count:
The Wilms tumor gene, WT1, encodes transcription factors that regulate cell proliferation, differentiation, and apoptosis. WT1 protein is highly expressed in malignant pleural mesothelioma MPM, and is a rational target for immunotherapy. We have developed a vaccine comprised of four WT1 heteroclitic peptides that are given together with Montanide and GM-CSF as immunologic adjuvants. This WT1 vaccine was previously tested in a small pilot trial, and shown to be safe and immunogenic. We have chosen to test the efficacy of this vaccine in MPM patients who have minimal disease burden after completion of multimodality therapy, but remain at exceedingly high risk for recurrence. The specific aim of this project is to conduct a multicenter, blinded, randomized trial comparing treatment with the WT-1 peptide vaccine MontanideGM-CSF to treatment with MontanideGM-CSF alone in patients with MPM who have completed multimodality therapy. The primary endpoint is progression free survival. The trial has opened at Memorial Sloan-Kettering and is actively enrolling patients.
APPROVED FOR PUBLIC RELEASE