From the blog

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

Published: June 16, 2014


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.

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. Patients with an R2 resection are also eligible as long as the sites of residual disease is treated post-operatively with radiotherapy.
  • 4-12 weeks since completion of combined modality therapy.
  • Age >/= 18 years.
  • Karnofsky performance status >/= 70%
  • Hematologic parameters: Absolute neutrophil count >/= 1000/mcL, Platelets > 50 K/mcL.
  • Biochemical parameters: Total bilirubin </= 2.0 mg/dl, AST and ALT </= 2.5 x upper limits of normal, Creatinine </= 2.0 mg/dl.
  • 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:
  • The patient is pregnant (confirmed by urine or serum Beta-HCG if applicable) or is breastfeeding.
  • 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 a known pre-existing immunodeficiency syndrome.
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