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

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ClinicalTrials.gov Identifier: NCT01265433
Recruitment Status : Completed
First Posted : December 23, 2010
Last Update Posted : November 5, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Sellas Life Sciences Group

Study Description
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Brief Summary:
Study of 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.

Condition or disease Intervention/treatment Phase
Malignant Pleural Mesothelioma Biological: WT-1-vaccine Montanide + GM-CSF Biological: Montanide adjuvant + GM-CSF (This arm is closed) Phase 2

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 21, 2010
Actual Primary Completion Date : July 25, 2017
Actual Study Completion Date : July 25, 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: WT-1-vaccine Montanide + GM-CSF
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.
 Biological: 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: Montanide adjuvant + GM-CSF (This arm is closed)
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.
 Biological: 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.


Outcome Measures
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Primary Outcome Measures :
  1. To assess the 1-year progression free survival in patients [ Time Frame: 1 year ]
    treated with WT-1 analog peptide vaccine + GM-CSF or Montanide + GM-CSF after completion of combined modality therapy for Malignant Pleural Mesothelioma (MPM). Progression free survival will be calculated from date of randomization to date of progression, death or last follow-up.


Secondary Outcome Measures :
  1. To confirm the immunogenicity of the WT-1 analog peptide vaccine [ Time Frame: 1 year ]
    in patients with MPM after completion of combined modality therapy.

  2. To assess the utility of using the serum marker [ Time Frame: 1 year ]
    (soluble mesothelin related protein (SMRP) in monitoring patients with MPM for disease progression.

  3. overall survival [ Time Frame: 1 year ]
    of patients treated with WT-1 analog peptide vaccine + GM-CSF or Montanide + GM-CSF after completion of combined modality therapy for MPM.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265433


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Sellas Life Sciences Group
United States Department of Defense
Investigators
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Principal Investigator: Marjorie Zauderer, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Sellas Life Sciences Group
ClinicalTrials.gov Identifier: NCT01265433    
Obsolete Identifiers: NCT01890980
Other Study ID Numbers: 10-134
First Posted: December 23, 2010    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Keywords provided by Sellas Life Sciences Group:
GM-CSF
MONTANIDE ISA 51
WT1 PEPTIDE SPECIFIC T CELLS
Vaccine
10-134
Additional relevant MeSH terms:
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Mesothelioma
Mesothelioma, Malignant
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Pleural Neoplasms
Lung Diseases
Respiratory Tract Diseases
Molgramostim
Sargramostim
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents