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Randomized Study of Adjuvant WT-1 Analog Peptide Vaccine in Patients With Malignant Pleural Mesothelioma (MPM) After Completion of Combined Modality Therapy

Published: January 12, 2011

Primary Outcome Measures:

  • To assess the 1-year progression free survival in patients [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    treated with WT-1 analog peptide vaccine + GM-CSF or Montanide + GM-CSF after completion of combined modality therapy for Malignant Pleural Mesothelioma (MPM).

Secondary Outcome Measures:

  • To confirm the immunogenicity of the WT-1 analog peptide vaccine [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    in patients with MPM after completion of combined modality therapy.
  • To assess the utility of using serum markers [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    (soluble mesothelin related protein (SMRP) and osteopontin) in monitoring patients with MPM for disease progression.

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.
  • 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.
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