Phase II Study of Adjuvant WT-1 Analog Peptide Vaccine in MPM Patients After MSK10-134
Conditions
Malignant Pleural Mesothelioma
Conditions: official terms
Mesothelioma
Conditions: Keywords
WT-1-vaccine Montanide, GM-CSF, Wilms Tumor-1 vaccine, immunotherapy, Montanide, Sargramostim, Granulocyte Macrophage Colony Stimulating Factor, Malignant Pleural Mesothelioma, MPM, soluble mesothelin related protein, SMRP
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention
Name: WT-1-vaccine Montanide + GM-CSF Type: Biological
Name: Montanide adjuvant + GM-CSF Type: Biological
Overall Status
Recruiting
Summary
The goal of this clinical research study is to learn if the Wilms Tumor-1 (WT1) vaccine, when given in combination with montanide and GM-CSF, can help to prevent or delay mesothelioma from coming back after surgery and treatment. The safety of this vaccine will also be tested.

Montanide and GM-CSF are designed to cause white blood cells to grow, which may help to increase the immune response.

WT1 is a protein in cancer cells that regulates gene expression and causes cell growth. Mesothelioma tumors usually have high levels of WT1. The WT1 vaccine is designed to cause the increased immune response created by other drug combinations (like montanide and GM-CSF) to be directed at mesothelioma.
Detailed Description
Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group:

- If you are in Group 1 you will receive montanide and GM-CSF.

- If you are in Group 2 you will receive montanide, GM-CSF, and the WT-1 vaccine. Neither you nor your doctor will know which group you are in. However, if needed for your safety, the study staff will be able to find out what you are receiving.

Study Drug Administration:

You will receive montanide through an injection under the skin every 2 weeks for up to 12 weeks (6 doses). If you are in Group 2, 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 78 patients will take part in this multicenter study. Up to 39 will be enrolled at MD Anderson.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
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 or another active cancer.

4. Patients taking systemic corticosteroids.

5. Patients with a known pre-existing immunodeficiency syndrome.
Locations
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Start Date
April 2013
Sponsors
M.D. Anderson Cancer Center
Source
M.D. Anderson Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page