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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

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Sloan-Kettering Institute for Cancer Research New York United States

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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, double-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.

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Technical Report,15 Aug 2014,14 Aug 2015




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Approved For Public Release;

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