Randomized Phase II Trial of Adjuvant WT-1 Analog Peptide Vaccine in Patients with Malignant Pleural Mesothelioma after Completion of Multimodality Therapy
Abstract
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. This study tested 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. A multicenter, blinded, randomized trial was conducted comparing treatment with the WT-1 peptide vaccine Montanide/GM-CSF to treatment with Montanide/GM-CSF alone in patients with MPM who have completed multimodality therapy. The primary endpoint is progression free survival rate at 1 year. The trial has completed and the results are being published in Clinical Cancer Research.
Document Details
- Document Type
- Technical Report
- Publication Date
- Nov 01, 2017
- Accession Number
- AD1047992
Entities
People
- Majorie G. Zauderer
Organizations
- Sloan-Kettering Institute