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Phase II Study of Adjuvant WT-1 Analog Peptide Vaccine in MPM Patients After MSK10-134

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ClinicalTrials.gov Identifier: NCT01890980
Recruitment Status : Active, not recruiting
First Posted : July 2, 2013
Last Update Posted : March 13, 2018
Sponsor:
Collaborators:
U.S. Army Medical Research and Materiel Command
Memorial Sloan Kettering Cancer Center
Sellas Life Sciences Group
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:

The goal of this clinical research study is to learn if the Wilms Tumor-1 (WT1) vaccine, when given in combination with montanide and GM-CSF, can help to prevent or delay mesothelioma from coming back after surgery and treatment. The safety of this vaccine will also be tested.

Montanide and GM-CSF are designed to cause white blood cells to grow, which may help to increase the immune response.

WT1 is a protein in cancer cells that regulates gene expression and causes cell growth. Mesothelioma tumors usually have high levels of WT1. The WT1 vaccine is designed to cause the increased immune response created by other drug combinations (like montanide and GM-CSF) to be directed at mesothelioma.


Condition or disease Intervention/treatment Phase
Malignant Pleural Mesothelioma Biological: WT-1-vaccine Montanide + GM-CSF Biological: Montanide adjuvant + GM-CSF Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 (MSK10-134)
Actual Study Start Date : April 2013
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

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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
Treatment of 6 injections over 12 weeks, administered on weeks 0, 2, 4, 6, 8, and 10. All receive Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 and -2 of each vaccination and may be self administered with appropriate instruction. Participants keep a logbook noting the time and placement of the injection, and will also receive 1.0 ml of emulsion with Montanide alone or with WT-1 peptides plus Montanide which will be administered by a nurse (not self-administered) subcutaneously to the same anatomical site as the GM-CSF as marked by the patient or treating healthcare professional by a permanent marker pen.

Biological: Montanide adjuvant + GM-CSF
Treatment of 6 injections over 12 weeks, administered on weeks 0, 2, 4, 6, 8, and 10. All receive Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 and -2 of each vaccination and may be self administered with appropriate instruction. Participants keep a logbook noting the time and placement of the injection, and will also receive 1.0 ml of emulsion with Montanide alone or with WT-1 peptides plus Montanide which will be administered by a nurse (not self-administered) subcutaneously to the same anatomical site as the GM-CSF as marked by the patient or treating healthcare professional by a permanent marker pen.
Active Comparator: Montanide adjuvant + 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
Treatment of 6 injections over 12 weeks, administered on weeks 0, 2, 4, 6, 8, and 10. All receive Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 and -2 of each vaccination and may be self administered with appropriate instruction. Participants keep a logbook noting the time and placement of the injection, and will also receive 1.0 ml of emulsion with Montanide alone or with WT-1 peptides plus Montanide which will be administered by a nurse (not self-administered) subcutaneously to the same anatomical site as the GM-CSF as marked by the patient or treating healthcare professional by a permanent marker pen.

Biological: Montanide adjuvant + GM-CSF
Treatment of 6 injections over 12 weeks, administered on weeks 0, 2, 4, 6, 8, and 10. All receive Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 and -2 of each vaccination and may be self administered with appropriate instruction. Participants keep a logbook noting the time and placement of the injection, and will also receive 1.0 ml of emulsion with Montanide alone or with WT-1 peptides plus Montanide which will be administered by a nurse (not self-administered) subcutaneously to the same anatomical site as the GM-CSF as marked by the patient or treating healthcare professional by a permanent marker pen.


Outcome Measures
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Primary Outcome Measures :
  1. 1-Year Progression Free Survival [ Time Frame: 1 Year ]
    Number of participants with 1-year progression free survival following treatment 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 calculated from date of randomization to date of progression, death or last follow-up.


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:

  1. Pathologic diagnosis of malignant pleural mesothelioma (MPM) confirmed at participating institution.
  2. Positive immunohistochemical staining for WT-1 (greater than 10% of cells).
  3. 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 sites of residual disease is treated post-operatively with radiotherapy.
  4. 4-12 weeks since completion of combined modality therapy.
  5. Age >/= 18 years.
  6. Karnofsky performance status >/= 70%
  7. Hematologic parameters: Absolute neutrophil count >/= 1000/mcL, Platelets > 50 K/mcL.
  8. Biochemical parameters: Total bilirubin </= 2.0 mg/dl, AST and ALT </= 2.5 x upper limits of normal, Creatinine </= 2.0 mg/dl.
  9. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Childbearing potential will be defined as a female that is able to have children that has not been surgically sterilized or amenorrheic for 12 consecutive months. The patient, if a man, agrees to use effective contraception or abstinence.

Exclusion Criteria:

  1. The patient is pregnant (confirmed by urine or serum Beta-HCG if applicable) or is breastfeeding.
  2. Patients with active infection requiring systemic antibiotics, antiviral, or antifungal treatments
  3. Patients with a serious unstable medical illness that would prevent compliance with the protocol or another active cancer.
  4. Patients taking systemic corticosteroids.
  5. Patients with a known pre-existing 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): NCT01890980


Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
U.S. Army Medical Research and Materiel Command
Memorial Sloan Kettering Cancer Center
Sellas Life Sciences Group
Investigators
Principal Investigator: Anne S. Tsao, MD Univeristy of Texas MD Anderson Cancer Center
More Information
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Additional Information:
University of Texas MD Anderson Cancer Center Website  This link exits the ClinicalTrials.gov site

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01890980     History of Changes
Other Study ID Numbers: 2011-0289
HRPO Log Number A-15872 ( Other Grant/Funding Number: U.S. Army Medical Research & Material Command (USAMRMC) )
NCI-2010-02375 ( Registry Identifier: NCI CTRP )
W81XWH-10-1-0699 ( Other Grant/Funding Number: Memorial Sloan-Kettering Cancer Center )
First Posted: July 2, 2013    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
WT-1-vaccine Montanide
GM-CSF
Wilms Tumor-1 vaccine
immunotherapy
Montanide
Sargramostim
 Granulocyte Macrophage Colony Stimulating Factor
Malignant Pleural Mesothelioma
MPM
soluble mesothelin related protein
SMRP

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Mesothelial
Vaccines
Immunologic Factors
Physiological Effects of Drugs