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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Malignant Pleural Mesothelioma

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Trial Information

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


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 site of residual disease is treated post-operatively with radiotherapy.

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

To assess the 1-year progression free survival in patients

Outcome Description:

treated 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 will be calculated from date of randomization to date of progression, death or last follow-up.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Lee Krug, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

10-134

NCT ID:

NCT01265433

Start Date:

December 2010

Completion Date:

December 2014

Related Keywords:

  • Malignant Pleural Mesothelioma
  • GM-CSF
  • MONTANIDE ISA 51
  • WT1 PEPTIDE SPECIFIC T CELLS
  • Vaccine
  • 10-134
  • Mesothelioma

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021