A Phase II Study of WT-1 Analog Peptide Vaccine in Patients with Malignant Pleural Mesothelioma

Full Title

Randomized Phase II Study of Adjuvant WT-1 Analog Peptide Vaccine in Patients with Malignant Pleural Mesothelioma (MPM) After Completion of Combined Modality Therapy

Purpose

The purpose of this study is to evaluate the effectiveness of a vaccine to delay or prevent recurrence of disease in patients with malignant pleural mesothelioma that has been surgically removed and treated with chemotherapy and radiation therapy. The vaccine is called the Wilms Tumor-1 (WT-1) vaccine. WT-1 is a protein in cancer cells that regulates gene expression and causes cell growth. Mesothelioma tumors generally have high levels of WT-1.

Patients in this study will be randomly assigned to one of two treatment groups. One group will receive non-specific immunotherapy with medications called montanide and GM-CSF. The other group will receive more specific immunotherapy with the WT-1 vaccine plus montanide and GM-CSF.

Both montanide and GM-CSF are commonly given with vaccines because they boost the immune response. Some researchers believe that this general increase in the immune system may have some effect in treating cancer.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have malignant pleural mesothelioma that has been surgically removed and treated with chemotherapy and radiation therapy.
  • Patients’ tumors must be positive for the WT-1 protein.
  • Four to 12 weeks must have passed between completion of prior therapy and entry into the study.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Marjorie Zauderer at 646-888-4656.

Protocol

10-134

Phase

II

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