Randomized Study of Adjuvant WT-1 Analog Peptide Vaccine in Patients With Malignant Pleural Mesothelioma (MPM) After Completion of Combined Modality Therapy
Conditions
Malignant Pleural Mesothelioma
Conditions: official terms
Mesothelioma
Conditions: Keywords
GM-CSF, MONTANIDE ISA 51, WT1 PEPTIDE SPECIFIC T CELLS, Vaccine, 10-134
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 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. The patient will be assigned to one of two treatment groups. One group will receive non-specific immunotherapy with medications called Montanide and Sargramostim (Granulocyte Macrophage Colony Stimulating Factor, GM-CSF). The other group will receive 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. The patient will have a 50% chance of being in each group. Neither the patient nor the doctor will be aware of which group they are in.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Location
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Lee Krug, MD - 646-888-4201
Start Date
December 2010
Completion Date
December 2016
Sponsors
Memorial Sloan Kettering Cancer Center
Source
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page