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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

Tracking Information
First Submitted Date  ICMJE December 21, 2010
First Posted Date  ICMJE December 23, 2010
Last Update Posted Date November 5, 2018
Actual Study Start Date  ICMJE December 21, 2010
Actual Primary Completion Date July 25, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 22, 2010)
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).
Change History Complete list of historical versions of study NCT01265433 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2011)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2010)
  • 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.
  • To assess the utility of using serum markers [ Time Frame: 1 year ]
    (soluble mesothelin related protein (SMRP) and osteopontin) in monitoring patients with MPM for disease progression.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE WT-1 Analog Peptide Vaccine in Malignant Pleural Mesothelioma After Combined Modality Therapy
Official Title  ICMJE Randomized Phase II Study of Adjuvant WT-1 Analog Peptide Vaccine in Patients With Malignant Pleural Mesothelioma (MPM) After Completion of Combined Modality Therapy
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Malignant Pleural Mesothelioma
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Biological: WT-1-vaccine Montanide + GM-CSF
  • 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.
    Intervention: Biological: Montanide adjuvant + GM-CSF (This arm is closed)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2016)
31
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2010)
78
Actual Study Completion Date  ICMJE July 25, 2017
Actual Primary Completion Date July 25, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01265433
Other Study ID Numbers  ICMJE 10-134
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sellas Life Sciences Group
Study Sponsor  ICMJE Sellas Life Sciences Group
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Principal Investigator: Marjorie Zauderer, MD Memorial Sloan Kettering Cancer Center
PRS Account Sellas Life Sciences Group
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP