Phase II Study of Adjuvant WT-1 Analog Peptide Vaccine in MPM Patients After MSK10-134

Study Drug Administration:

When this study opened, it had 2 groups. In 1 of the groups, participants only received
montanide and GM-CSF. This group has stopped enrolling participants. All participants will
now receive montanide, GM-CSF, and the WT1 vaccine.

You will receive montanide through an injection under the skin every 2 weeks for up to 12
weeks (6 doses). You will receive the WT-1 vaccine at the same time that you receive
montanide.

You will also receive GM-CSF through an injection under the skin on the day you receive
montanide and 2 days before you receive montanide each time (12 doses of GM-CSF total). If
the doctor thinks it is in your best interest, you might be taught how to inject the GM-CSF
yourself.

Study Visits:

On Week 2, Week 6, and Week 12, you will have a physical exam, including measurement of your
weight and vital signs. You will also be asked about any drugs you may be taking and any side
effects you may be having.

At Weeks 6 and 12, the following tests and procedures will also be performed:

- Your performance status will be recorded.

- Blood (about 4 teaspoons) will be drawn for routine tests.

- Blood (about 2 tablespoons) will be drawn to check your level of SMRP.

- Blood (about 7 tablespoons) will be drawn to check your immune response to the study
drug(s) (Week 12 only).

At Week 12 or earlier if the doctor thinks it is needed, you will have a chest x-ray and CT
scan of the chest to check the status of the disease.

Length of Study:

You will receive the study drugs for up to 12 weeks. You will be taken off study if the study
doctor thinks it is in your best interest or you have intolerable side effects.

Your participation in the study will be over after the follow-up visits.

Follow-Up:

Within 30 days after you stop receiving the study drugs, you will have a physical exam,
including measurement of your weight and vital signs. You will also be asked about any drugs
you may be taking and any side effects you may be having.

Every 3 months for up to 2 years after you stop receiving the study drugs, the following
tests and procedures will be performed:

- Your medical history will be recorded

- You will have a physical exam, including measurement of your weight and vital signs.

- You will be asked about any drugs you may be taking and any side effects you may be
having.

- Blood (about 2 tablespoons) will be drawn for routine tests and to measure your levels
of SMRP.

- You will have a CT scan of the chest to check the status of the disease

This is an investigational study. GM-CSF is FDA approved for helping the immune system in
patients with acute myelogenous leukemia. Montanide and Wilms Tumor-1 (WT1) are not FDA
approved or commercially available. They are currently being used for research purposes only.

The combination of WT-1 vaccine with montanide and GM-CSF is not FDA approved or commercially
available. It is currently being used for research purposes only.

Up to 60 patients will take part in this multicenter study. Up to 20 will be enrolled at MD
Anderson.

Inclusion Criteria:

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

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

3. 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 sites
of residual disease is treated post-operatively with radiotherapy.

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

5. Age >/= 18 years.

6. Karnofsky performance status >/= 70%

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

8. Biochemical parameters: Total bilirubin limits of normal, Creatinine
9. Women of childbearing potential must agree to use adequate contraception (hormonal or
barrier method of birth control; abstinence) prior to study entry and for the duration
of study participation. Childbearing potential will be defined as a female that is
able to have children that has not been surgically sterilized or amenorrheic for 12
consecutive months. The patient, if a man, agrees to use effective contraception or
abstinence.

Exclusion Criteria:

1. The patient is pregnant (confirmed by urine or serum Beta-HCG if applicable) or is
breastfeeding.

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

3. Patients with a serious unstable medical illness that would prevent compliance with
the protocol or another active cancer.

4. Patients taking systemic corticosteroids.

5. Patients with a known pre-existing immunodeficiency syndrome.