A Phase 1 Study of SGT-53, a TfRscFv-Liposome-p53 Complex, in Children with Refractory or Recurrent Solid Tumors
Patients with recurrent or refractory solid tumors, excluding CNS tumors. Patient’s current disease state must be one for which there are no known curative treatment options or therapies proven to prolong survival with an acceptable quality of life.
SGT-53 is designed to deliver normal human p53 DNA to tumor cells, which allows for cell death when treated with conventional chemotherapeutic agents. SGT-53 will be administered intravenously as a single agent twice weekly for 3 weeks during cycle 1. For cycles 2-4, SGT-53 will be administered twice weekly in combination with topotecan and cyclophosphamide given intravenously daily for 5 days of each 21-day cycle, followed by growth factor injections. Patients will receive a maximum of 4 cycles.
- Patients must be between 12 months and 21 years of age.
- Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy and have the appropriate wash-out period from most recent cancer directed therapy.
- Must not have had prior exposure to gene vector delivery products within 3 months or had prior SGT-53. Patients who have received prior topotecan, cyclophosphamide, or both are eligible.
- Must have adequate organ function as evidenced by laboratory criteria.
- Patients receiving corticosteroids must be on a stable or decreasing dose for at least 7 days prior to enrollment.
- Must not be receiving any anti-GVHD agents post-transplant.
- Must not have received a prior solid organ transplantation.
For the current status and more detailed eligibility criteria of these clinical studies & protocols, referring physicians and families may call the Developmental Therapeutics Program directly at (832) 824-4266 at any time. Kate Mazur, a pediatric nurse practitioner for the Developmental Therapeutics Program, will answer any questions or concerns you may have. You may need to leave a voice mail, and she will return your call as soon as possible. She may also be reached by email at firstname.lastname@example.org.