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
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)
Description
This is an open-label, single-arm, non-randomized, phase I/II trial 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. This is the first time that PEEL-224 will be given in combination with Vincristine and Temozolomide to humans. In Phase 1, the safety and tolerability of PEEL-224 in combination with Vincristine and Temozolomide will be assess…
Eligibility
- Age range
- 12–49 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: -Patients in all cohorts must have relapsed or refractory disease after standard therapy. Inclusion Criteria Phase 1 (only) diagnosis requirements: -Patients must have: * Evaluable or measurable disease; and * Histologic diagnosis of sarcoma Inclusion Criteria Phase 2 (only) diagnosis requirements * EWS cohort: Patients must have: * RECIST measurable disease at study entry; * Histologic diagnosis consistent with Ewing sarcoma; and * Molecular evidence of a FET-ETS family translocation including but not limited to any of the following: * EWSR1::FLI1, EWSR1:…
Interventions
- DrugPEEL-224
Topoisomerase 1 inhibitor, 200mg amber vial, via intravenous (into the vein) infusion per protocol.
- DrugTemozolomide
Alkylating agent, 5, 20, 100, 140, 180, or 250 mg capsule, taken orally per standard of care.
- DrugVincristine
Vinca alkaloid, 1 or 2mL vials, via intravenous (into the vein) infusion per institutional policy.
- BiologicalPegfilgrastim
Myeloid growth factor administered per institutional standards.
- BiologicalFilgrastim
Myeloid growth factor administered per institutional standards.
Locations (3)
- Boston Children's HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Brigham and Women's HospitalBoston, Massachusetts