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Metastatic Pancreatic Cancer - Healing Genes
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Metastatic Pancreatic Cancer

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Study of Combined SGT-53 Plus Gemcitabine/Nab-Paclitaxel for Metastatic Pancreatic Cancer

Phase II Study of Combined Targeted p53 Gene Therapy (SGT-53) Plus Gemcitabine/Nab-Paclitaxel for Treatment of Metastatic Pancreatic Cancer


Phase 2

DESCRIPTION:

Doctors at the Mary Crowley Cancer Research Center seek participants with metastatic pancreatic cancer 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 gemcitabine/Abraxane® chemotherapy (the standard of care for such tumors).

The drug will be infused 2x weekly for 7 weeks, with gemcitabine/Abraxane® will be administered by mouth 1x weekly. The frequency of dosage may increase over the 7 weeks, and if tolerated well, a second cycle of 7 weeks is optional. Chemotherapy may also continue if well-tolerated and doctors agree. The goal is for patients to experience progression-free survival of their cancer for over 5 months, with follow-up for 2 years.


PATIENT MUST:

  • Be 18 years of age and older
  • Have histologic or cytologic diagnosis of stage IV metastatic pancreatic adenocarcinoma
  • Not be pregnant or breast-feeding

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. In week 1 SGT-53 will be administered on day 1 and day 5,
  3. Gemcitabine chemotherapy will be administered on day 3 of each week except week 4.
  4. If the combination is well-tolerated, starting at week 2, infusion of SGT-53 will be administered bi-weekly on days 1 and 5 in weeks 2-3, weekly on day 3 in week 4, and weekly on day 1 in weeks 5-7.
  5. Patients who are responding to treatment may receive one additional course (7 weeks) of SGT-53/gemcitabine therapy at investigator discretion. If still responding to treatment, they may continue on gemcitabine/nab-paclitaxel alone at investigator discretion.
  6. Follow up will continue for 2 years.

LOCATIONS AND CONTACTS:
The study site is at Mary Crowley Cancer Research Center    in Dallas, TX, Map.
Contact:
Referral Office  |  972-566-3000  |  [email protected]
Alyssa Roth  |  972-566-3061  |  [email protected]
 
SPONSOR INFORMATION:
SynerGene Therapeutics, Inc..
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT02340117

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