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Ewing’s Sarcoma - Healing Genes
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Ewing’s Sarcoma

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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


Phase 1

DESCRIPTION:

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.


PATIENT MUST:

  • 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:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. 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.
  3. 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:

The study sites are Memorial Sloan Kettering Cancer Center in NY, Map, and the Mary Crowley Cancer Research Centers in TX. Map.

Contact: Gladice Wallraven  |  214-442-8124  |  [email protected]

 

 

SPONSOR INFORMATION:

Gradalis, Inc.

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT02736565

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