Vaccine Therapy in Treating Patients with Malignant Mesothelioma Previously Treated with Combined Modality Therapy

  • Resize font
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest

Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IITreatment18 and over10-134
NCI-2010-02375, NCT01265433

Trial Description

Summary

This randomized phase II trial studies how well vaccine therapy works in treating patients with malignant mesothelioma. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells that express human Wilms tumor 1 (WT-1).

Further Study Information

PRIMARY OBJECTIVES:

I. To assess the 1-year progression free survival in patients treated with WT-1 analog peptide vaccine + GM-CSF (sargramostim) or Montanide (montanide ISA 51 VG) + GM-CSF after completion of combined modality therapy for malignant pleural mesothelioma (MPM).

SECONDARY OBJECTIVES:

I. To confirm the immunogenicity of the WT-1 analog peptide vaccine in patients with MPM after completion of combined modality therapy.

II. To assess the utility of using serum marker, soluble mesothelin related protein (SMRP), in monitoring patients with MPM for disease progression.

III. To assess the 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.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive sargramostim subcutaneously (SC) and montanide ISA 51 VG SC on days -2 and 0 of weeks 0, 2, 4, 6, 8, and 10.

ARM II: Patients receive treatment as in Arm I. Patients also receive WT-1 analog peptide vaccine SC on days -2 and 0 of weeks 0, 2, 4, 6, 8, and 10.

After completion of study treatment, patients are followed up every 3 months for 2 years.

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)

Karnofsky performance status >= 70%

4-12 weeks since completion of combined modality therapy

Absolute neutrophil count >= 1000/mcL

Platelets > 50 K/mcL

Total bilirubin =< 2.0 mg/dl

Creatinine =< 2.0 mg/dl

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limits of normal

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

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

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Memorial Sloan-Kettering Cancer Center

  • National Cancer Institute
Lee M. Krug, Principal Investigator

Trial Sites

U.S.A.

New York
New York

Memorial Sloan-Kettering Cancer Center

Lee M. Krug
Ph: 646-888-4201
Email: krugl@mskcc.org

Lee M. Krug
Principal Investigator

See All Trial Sites

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01265433

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.