Status:
COMPLETED
Galinpepimut-S (WT-1 Analog Peptide) Vaccine in Malignant Pleural Mesothelioma After Combined Modality Therapy
Lead Sponsor:
Sellas Life Sciences Group
Collaborating Sponsors:
United States Department of Defense
Conditions:
Malignant Pleural Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Study of galinpepimut-S, a Wilms Tumor-1 (WT1) vaccine, to see if it delays or prevents the mesothelioma from growing back after surgery. WT1 is a protein in cancer cells that regulates gene expressio...
Detailed Description
The doctors are testing galinpepimut-S, a Wilms Tumor-1 (WT1) vaccine, to see if it delays or prevents the mesothelioma from growing back after surgery. WT1 is a protein in cancer cells that regulates...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 21 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2017
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01265433
Start Date
December 21 2010
End Date
July 25 2017
Last Update
October 9 2024
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065