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

Primary Purpose

Malignant Pleural Mesothelioma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
WT-1-vaccine Montanide + GM-CSF
Montanide adjuvant + GM-CSF (This arm is closed)
Sponsored by
Sellas Life Sciences Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Pleural Mesothelioma focused on measuring GM-CSF, MONTANIDE ISA 51, WT1 PEPTIDE SPECIFIC T CELLS, Vaccine, 10-134

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

WT-1-vaccine Montanide + GM-CSF

Montanide adjuvant + GM-CSF (This arm is closed)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

To assess the 1-year progression free survival in patients
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

To confirm the immunogenicity of the WT-1 analog peptide vaccine
in patients with MPM after completion of combined modality therapy.
To assess the utility of using the serum marker
(soluble mesothelin related protein (SMRP) in monitoring patients with MPM for disease progression.
overall survival
of patients treated with WT-1 analog peptide vaccine + GM-CSF or Montanide + GM-CSF after completion of combined modality therapy for MPM.

Full Information

First Posted
December 21, 2010
Last Updated
November 1, 2018
Sponsor
Sellas Life Sciences Group
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT01265433
Brief Title
WT-1 Analog Peptide Vaccine in Malignant Pleural Mesothelioma After Combined Modality Therapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 21, 2010 (Actual)
Primary Completion Date
July 25, 2017 (Actual)
Study Completion Date
July 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sellas Life Sciences Group
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Mesothelioma
Keywords
GM-CSF, MONTANIDE ISA 51, WT1 PEPTIDE SPECIFIC T CELLS, Vaccine, 10-134

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WT-1-vaccine Montanide + GM-CSF
Arm Type
Experimental
Arm Description
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.
Arm Title
Montanide adjuvant + GM-CSF (This arm is closed)
Arm Type
Active Comparator
Arm Description
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 Type
Biological
Intervention Name(s)
WT-1-vaccine Montanide + GM-CSF
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Montanide adjuvant + GM-CSF (This arm is closed)
Intervention Description
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 Outcome Measure Information:
Title
To assess the 1-year progression free survival in patients
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To confirm the immunogenicity of the WT-1 analog peptide vaccine
Description
in patients with MPM after completion of combined modality therapy.
Time Frame
1 year
Title
To assess the utility of using the serum marker
Description
(soluble mesothelin related protein (SMRP) in monitoring patients with MPM for disease progression.
Time Frame
1 year
Title
overall survival
Description
of patients treated with WT-1 analog peptide vaccine + GM-CSF or Montanide + GM-CSF after completion of combined modality therapy for MPM.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjorie Zauderer, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

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

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