Overview

This trial is active, not recruiting.

Condition malignant pleural mesothelioma
Treatments wt-1-vaccine montanide + gm-csf, montanide adjuvant + gm-csf (this arm is closed)
Phase phase 2
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator United States Department of Defense
Start date December 2010
End date December 2016
Trial size 31 participants
Trial identifier NCT01265433, 10-134

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.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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
The study will be a randomized phase II trial to determine the 1-year progression free survival after treatment with WT-1 analog peptide vaccine in patients with MPM after completion of combined modality therapy.
wt-1-vaccine montanide + gm-csf
Patients will receive 6 injections over 12 weeks. Treatment will be administered on weeks 0, 2, 4, 6, 8, and 10. All patients will receive Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 and -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) on day -2 if they have been appropriately instructed on SQ injection administration. Patients will be informed of the expected reactions such as irritation at the injection site. Patients will keep a logbook noting the time and placement of the injection. Patients will also receive 1.0 ml of emulsion with Montanide alone or with WT-1 peptides plus Montanide. It will be administered by a nurse (it may not be self administered) subcutaneously to the same anatomical site as the GM-CSF. This site will be marked by the patient or treating healthcare professional by a permanent marker pen.
(Active Comparator)
The study will be a randomized phase II trial to determine the 1-year progression free survival after treatment with WT-1 analog peptide vaccine in patients with MPM after completion of combined modality therapy.
montanide adjuvant + gm-csf (this arm is closed)
Patients will receive 6 injections over 12 weeks. Treatment will be administered on weeks 0, 2, 4, 6, 8, and 10. All patients will receive Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 and -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) on day -2 if they have been appropriately instructed on SQ injection administration. Patients will be informed of the expected reactions such as irritation at the injection site. Patients will keep a logbook noting the time and placement of the injection. Patients will also receive 1.0 ml of emulsion with Montanide alone or with WT-1 peptides plus Montanide. It will be administered by a nurse (it may not be self-administered)subcutaneously to the same anatomical site as the GM-CSF. This site will be marked by the patient or treating healthcare professional by a permanent marker pen.

Primary Outcomes

Measure
To assess the 1-year progression free survival in patients
time frame: 1 year

Secondary Outcomes

Measure
To confirm the immunogenicity of the WT-1 analog peptide vaccine
time frame: 1 year
To assess the utility of using the serum marker
time frame: 1 year
overall survival
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official 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
Principal investigator Marjorie Zauderer, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.
Location data was received from the National Cancer Institute and was last updated in September 2016.