Clinical Trials Search
Clinical Trial 18350
Cancer Type: Sarcoma
Interventions:MESNA; NY-ESO-1c259T; Neupogen (filgrastim); cyclophosphamide; cytoxan (cyclophosphamide); filgrastim; fludarabine (Fludarabine phosphate)
Study Type: Treatment
Phase of Study: Pilot
- Mihaela Druta
A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1c259T in HLA-A2+ Patients with Synovial Sarcoma
The purpose of this early (pilot) clinical trial is to test the effects (both good and bad) of chemotherapy and adoptive immunotherapy with T cells engineered to recognize NY-ESO-1 peptide in patients with unresectable, metastatic or recurrent synovial sarcoma.
1.1.1 Primary: Determine the safety of treatment with adoptively transferred NY-ESO-1c259T in patients with unresectable, metastatic or recurrent synovial sarcoma. Determine the efficacy through response rate and duration in patients with unresectable, metastatic or recurrent synovial sarcoma treated with lymphodepletion and Treg depletion followed by adoptive immunotherapy with T cells engineered to recognize an HLA-A2 restricted NY-ESO-1 derived peptide, but without aldesleukin. 1.1.2 Secondary: Determine the response rate and duration when patients with low NY-ESO-1 expression are treated with NY-ESO-1c259T. Determine the response rate and duration when NY-ESO-1c259T is administered with a lymphodepletion regimen that does not contain fludarabine. Evaluate persistence and expansion of adoptively transferred NY-ESO-1c259T and correlate with clinical responses. Monitor T-cell subsets in the adoptively transferred cells and in patients treated, and compare clinical outcomes with T-cell subsets levels. When possible, assess whether patients with progressive disease following NY-ESO-1c259T experience a response following a second dose administered with aldesleukin. 1.1.3 Exploratory: Evaluate candidate biomarkers in tumor tissue, including NY-ESO-1 expression, modulation in tumor infiltrating T-cells pre and post-infusion, etc. and correlate with clinical response to treatment. Evaluate candidate biomarkers in blood samples and correlate with clinical response to treatment. Evaluate antigen spreading within the tumor using molecular and immunohistochemical analyses of the diversity of infiltrating T cell clones in pre and post-infusion tumor tissue.