WT-1 Analog Peptide Vaccine in Malignant Pleural Mesothelioma After Combined Modality Therapy

The doctors are testing a Wilms Tumor-1 (WT1) vaccine to see if it delays or prevents the
mesothelioma from growing back after surgery. WT1 is a protein in cancer cells that regulates
gene expression and causes cell growth. Mesothelioma tumors generally have high levels of
WT1.This study was originally designed to have two treatment groups. One group received
non-specific immunotherapy with medications called Montanide and Sargramostim (Granulocyte
Macrophage Colony Stimulating Factor, GM-CSF). Enrollment to this group has stopped The other
group, which continues receives more specific immunotherapy with the WT1 vaccine plus
Montanide and GM-CSF. Both Montanide and GM-CSF are commonly given along with vaccines
because they have a general effect in boosting the immune response. Some researchers believe
that this general increase in the immune system may have some effect in treating cancer. Some
studies using GM-CSF with melanoma vaccines have suggested that it could lessen the effects
of the vaccine. The addition of the WT1 proteins makes this therapy more directed to
mesothelioma. The combination of WT1 vaccine with Montanide and GM-CSF has been tested in a
prior trial including 9 patients with advanced mesothelioma. In that trial, the vaccine was
safe and caused an immune response.

Inclusion Criteria:

- Pathologic diagnosis of malignant pleural mesothelioma (MPM) confirmed at
participating institution.

- Positive immunohistochemical staining for WT-1 (greater than 10% of cells).

- Completion of multimodality therapy. This must include surgical resection by either
pleurectomy/decortication or extrapleural pneumonectomy. The surgery should be
performed with the intent of complete resection, though patients with an R1 resection
will still be eligible. Patients should have also received treatment with chemotherapy
and/or radiation. Patients with an R2 resection are also eligible as long as the site
of residual disease is treated post-operatively with radiotherapy.

- 4-12 weeks since completion of combined modality therapy.

- Age > or = to 18 years

- Karnofsky performance status > or = to 70%

- Hematologic parameters: Absolute neutrophil count > or = to 1000/mcL, Platelets > or =
to 50K/mcL.

- Biochemical parameters: Total bilirubin < or = to 2.0 mg/dl, AST and ALT < or = to 2.5
x upper limits of normal, Creatinine < or = to 2.0 mg/dl.

Exclusion Criteria:

- Pregnant or lactating women.

- Patients with active infection requiring systemic antibiotics, antiviral, or
antifungal treatments.

- Patients with a serious unstable medical illness or another active cancer.

- Patients taking systemic corticosteroids.

- Patients with an immunodeficiency syndrome.