Phase 1/2 Trial to Evaluate the Safety and Efficacy of PEEL-224 in Combination With Vincristine and Temozolomide in Adolescents and Young Adults With Relapsed or Refractory Sarcomas
David S Shulman, MD
63 participants
Jan 27, 2025
INTERVENTIONAL
Conditions
Summary
This research is being done to test a new drug called PEEL-224 in combination with two commercially available drugs, Vincristine and Temozolomide, and to determine how effective this combination of drugs is at treating Ewing Sarcoma (EWS) and Desmoplastic Small Round Cell Tumor (DSRCT), as well as multiple other kinds of sarcomas. The names of the study drugs and biological agents involved in this study are: * PEEL-224 (a type of Topoisomerase 1 inhibitor) * Vincristine (A type of vinca alkaloid) * Temozolomide (A type of alkylating agent) * Pegfilgrastim or Filgrastim (types of Myeloid growth factors)
Eligibility
Plain Language Summary
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Interventions
Topoisomerase 1 inhibitor, 200mg amber vial, via intravenous (into the vein) infusion per protocol.
Alkylating agent, 5, 20, 100, 140, 180, or 250 mg capsule, taken orally per standard of care.
Vinca alkaloid, 1 or 2mL vials, via intravenous (into the vein) infusion per institutional policy.
Myeloid growth factor administered per institutional standards.
Myeloid growth factor administered per institutional standards.
Locations(3)
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NCT06709495