- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01265433
WT-1 Analog Peptide Vaccine in Malignant Pleural Mesothelioma After Combined Modality Therapy
November 1, 2018 updated by: Sellas Life Sciences Group
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 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
31
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
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.
|
1 year
|
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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Marjorie Zauderer, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 21, 2010
Primary Completion (Actual)
July 25, 2017
Study Completion (Actual)
July 25, 2017
Study Registration Dates
First Submitted
December 21, 2010
First Submitted That Met QC Criteria
December 22, 2010
First Posted (Estimate)
December 23, 2010
Study Record Updates
Last Update Posted (Actual)
November 5, 2018
Last Update Submitted That Met QC Criteria
November 1, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Mesothelioma
- Mesothelioma, Malignant
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Sargramostim
- Monatide (IMS 3015)
- Molgramostim
Other Study ID Numbers
- 10-134
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Malignant Pleural Mesothelioma
-
NRG OncologyNational Cancer Institute (NCI)TerminatedPleural Biphasic Mesothelioma | Pleural Epithelioid Mesothelioma | Stage I Pleural Malignant Mesothelioma AJCC v8 | Stage IA Pleural Malignant Mesothelioma AJCC v8 | Stage IB Pleural Malignant Mesothelioma AJCC v8 | Stage II Pleural Malignant Mesothelioma AJCC v8 | Stage IIIA Pleural Malignant...United States, Canada
-
University of ChicagoNational Cancer Institute (NCI)Active, not recruitingBiphasic Mesothelioma | Epithelioid Mesothelioma | Peritoneal Malignant Mesothelioma | Pleural Biphasic Mesothelioma | Pleural Epithelioid Mesothelioma | Pleural Malignant Mesothelioma | Pleural Sarcomatoid Mesothelioma | Recurrent Peritoneal Malignant Mesothelioma | Recurrent Pleural Malignant Mesothelioma and other conditionsUnited States
-
National Cancer Institute (NCI)Active, not recruitingBiphasic Mesothelioma | Epithelioid Mesothelioma | Stage III Pleural Malignant Mesothelioma AJCC v7 | Stage I Pleural Malignant Mesothelioma AJCC v7 | Stage IA Pleural Malignant Mesothelioma AJCC v7 | Stage IB Pleural Malignant Mesothelioma AJCC v7 | Stage II Pleural Malignant Mesothelioma AJCC...United States
-
RS Oncology LLCRecruitingMesothelioma | Malignant Pleural Mesothelioma | Pleural Effusion, Malignant | Mesotheliomas Pleural | Malignant Pleural Effusion | Mesothelioma; LungUnited Kingdom
-
Health Pharma Professional ResearchWithdrawnMalignant Pleural Mesothelioma, Advanced | Malignant Pleural Mesothelioma, UnresectableMexico
-
National Cancer Institute (NCI)TerminatedEpithelioid Mesothelioma | Sarcomatoid Mesothelioma | Stage IV Pleural Mesothelioma | Recurrent Malignant Mesothelioma | Stage II Pleural Mesothelioma | Stage III Pleural MesotheliomaUnited States
-
National Cancer Institute (NCI)WithdrawnMalignant Pleural Mesotheliomas (Mpm) | Malignant Pleural Effusions (Mpe) | Epithelial Tumors, Malignant | Pleural Effusions, Malignant | Mesothelin (Msln)United States
-
Royal Marsden NHS Foundation TrustMerck Sharp & Dohme LLCTerminatedAdvanced Malignant Pleural MesotheliomaUnited Kingdom
-
Abramson Cancer Center at Penn MedicineRecruitingEpitheliod Malignant Pleural MesotheliomaUnited States
-
Swiss Group for Clinical Cancer ResearchCompletedMalignant Pleural Mesothelioma, AdvancedSwitzerland, Italy
Clinical Trials on WT-1-vaccine Montanide + GM-CSF
-
H. Lee Moffitt Cancer Center and Research InstituteInnovive PharmaceuticalsCompletedLeukemiaUnited States
-
San Antonio Military Medical CenterNuGenerex Immuno-Oncology; Norwell, Inc.CompletedBreast CancerUnited States, Germany, Greece
-
COL George Peoples, MD, FACSCompletedOvarian Cancer | Endometrial Cancer | Peritoneal Cancer | Fallopian CancerUnited States
-
COL George Peoples, MD, FACSUniformed Services University of the Health SciencesCompletedBreast CancerUnited States
-
COL George Peoples, MD, FACSUniformed Services University of the Health SciencesCompleted
-
University of VirginiaCompleted
-
Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI); Alliance for Cancer Gene TherapyTerminatedMyelodysplastic SyndromesUnited States
-
Dana-Farber Cancer InstituteBrigham and Women's HospitalCompletedRefractory Acute Myeloid Leukemia | Myelodysplastic Syndrome RAEB-I or RAEB-II | Refractory CML Myeloid Blast CrisisUnited States
-
National Cancer Institute (NCI)CompletedLymphoma | Follicular Lymphoma | B Cell LymphomaUnited States
-
National Cancer Institute (NCI)CompletedVaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic CancerOvarian Endometrioid Adenocarcinoma | Adenocarcinoma of the Pancreas | Recurrent Pancreatic Cancer | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Recurrent Breast Cancer | Stage IV Colon Cancer | Stage IV Rectal Cancer and other conditionsUnited States