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 2013-14 Aug 2014
SLOAN-KETTERING INST FOR CANCER RESEARCH NEW YORK
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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 pilot trial, and shown to be safe and immunogenic. We are now testing 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 is open at Memorial Sloan-Kettering and MD Anderson Cancer Center and is actively accruing.
- Medicine and Medical Research