Pbi-shRNA™ EWS/FLI1 Type 1 LPX in Subjects With Advanced Ewing’s Sarcoma
Phase I Trial of Pbi-shRNA™ EWS/FLI1 Type 1 Lipoplex (LPX) in Subjects With Advanced Ewing’s Sarcoma
Doctors at the Memorial Sloan Kettering Cancer Center in NY and the Mary Crowley Cancer Research Centers in TX seek participants with Ewing’s Sarcoma to undergo a novel treatment to stop the expression of the EWS/FLI1 fusion gene. The EWS/FLI1 gene is well known as the driver gene of Ewing’s sarcoma. The investigatory treatment delivers a specially engineered loop of DNA. The DNA works to produce molecules that will stop the expression of the faulty EWS/FLI1 gene. By slowing or stopping the expression of the faulty gene, the sarcoma may be stopped.
An infusion of the drug will be required twice a week for 4 weeks (8 infusions) followed by 2 weeks of rest. Treatment may continue as long as there is clinical benefit, no evidence of disease progression, and no other withdrawal criteria are met.
- Be 8 years of age and older
- Be diagnosed with Ewing’s Sarcoma Family of Tumors, with genetic confirmation of the target faulty EWS/FLI1 gene
- Be HIV, Hep B and Hep C negative
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility of the patient to participate.
- An intravenous infusion will be administered twice a week for 4 weeks (e.g. Mon and Thurs, preferred) for a total of 8 infusions of the product per cycle followed by 2 weeks of rest.
- Treatment may continue as long as there is clinical benefit, no evidence of disease progression, and no other withdrawal criteria are met.
LOCATIONS AND CONTACTS:
Contact: Gladice Wallraven | 214-442-8124 | [email protected]
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