Trial record 10 of 25 for:    pleural plaque OR pleural effusion OR asbestosis OR mesothelioma | Open Studies | NIH, U.S. Fed

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborators:
U.S. Army Medical Research and Materiel Command
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01890980
First received: June 27, 2013
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Malignant Pleural Mesothelioma
Biological: WT-1-vaccine Montanide + GM-CSF
Biological: Montanide adjuvant + GM-CSF
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 1-Year Progression Free Survival [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 39
Study Start Date: April 2013
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 or another active cancer.
  4. Patients taking systemic corticosteroids.
  5. Patients with a known pre-existing immunodeficiency syndrome.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01890980

Contacts
Contact: Anne S. Tsao, MD 713-792-6363

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Anne S. Tsao, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
U.S. Army Medical Research and Materiel Command
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Anne S. Tsao, MD Univeristy of Texas MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

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, NCI-2010-02375
Study First Received: June 27, 2013
Last Updated: June 2, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial

ClinicalTrials.gov processed this record on July 28, 2014