CompletedPhase 2NCT01265433

Galinpepimut-S (WT-1 Analog Peptide) Vaccine in Malignant Pleural Mesothelioma After Combined Modality Therapy

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 expression and causes cell growth.

Checked against the public recordLast updated Oct 9, 2024 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations1
SponsorSellas Life Sciences Group
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Sellas Life Sciences Group
Interventions being studied
Biological: Galinpepimut-S + Montanide + GM-CSF; Biological: Montanide + GM-CSF
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Treatment approach
03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Memorial Sloan Kettering Cancer CenterNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 9, 2024. Always confirm current availability with the study team.

View original record ↗