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Recurrent Glioblastoma - Healing Genes
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Recurrent Glioblastoma

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Phase II Study of Combined Temozolomide and SGT-53 for Treatment of Recurrent Glioblastoma

Phase II Study of Combined Temozolomide and Targeted P53 Gene Therapy (SGT-53) for Treatment of Patients With Recurrent Glioblastoma


Phase 1

DESCRIPTION:

Doctors at the MD Anderson Cancer Center seek participants with Recurrent Glioblastoma to undergo a genetic therapy to improve expression of a tumor suppression gene that halts tumor replication, or growth. The investigatory treatment delivers a specially engineered loop of DNA. The DNA works to produce molecules to regulate normal cell death that the tumor has stopped making, This drug, called SGT-53 nanocomplex, is given in combination with temozolomide chemotherapy (the standard of care for Glioblastoma Multiforme (GBM) brain tumors).

The drug will be infused 2x weekly for 3 months. Temozolomide (TMZ) will be administered by mouth daily for 5 days of each month. Patients who are responding to treatment may receive three additional cycles of the therapy or continue on TMZ alone at investigator’s discretion. Surgical resection of recurrent or progressive tumor for tumor analysis is an optional procedure. In these individuals SGT-53 will be administered twice in the week prior to surgery. After surgical recovery period, the patients will then start cyclical TMZ with SGT-53 as described above. Follow up will continue for 180 days.


PATIENT MUST:

  • Be 18 years of age and older
  • Have confirmed glioblastoma or gliosarcoma in 1st, 2nd or 3rd relapse
  • Be HIV-negative

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. SGT-53 DNA therapy will be administered twice weekly in a 28 day cycle starting on Day 1 (cycle 1), Day 29 (cycle 2) and Day 57 (cycle 3).
  3. Temozolomide (TMZ) will be administered by mouth daily on days 9-13 of each cycle.
  4. Patients who are responding to treatment may receive three additional cycles of SGT-53/TMZ therapy or continue on TMZ alone at investigator’s discretion.
  5. Surgical resection of recurrent or progressive tumor for tumor analysis is an optional procedure. In these individuals SGT-53 will be administered twice in the week prior to surgery.
  6. After recovery from the surgical procedure, the patients will then start cyclical TMZ with SGT-53 as in step (2).
  7. Follow up will continue for 180 days.

LOCATIONS AND CONTACTS:
The study site is at MD Anderson Cancer Center in Houston, TX, Map.
Contact:
Kathy Hunter  |  713-745-5769  |  [email protected]
Winnie Wu  |  713-794-1286  |  [email protected]
 
SPONSOR INFORMATION:
SynerGene Therapeutics, Inc..
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT02340156

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