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

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 grow

Trial Details

NCT ID

NCT06709495

Phase

PHASE1 / PHASE2

Sponsor

David S Shulman, MD

Status

RECRUITING

Cancer Type

Osteosarcoma Sarcoma

Interventions

PEEL-224
Temozolomide
Vincristine
Pegfilgrastim
Filgrastim

Locations (sample)

Boston, Massachusetts, United States|42.35843,-71.05977
Boston, Massachusetts, United States|42.35843,-71.05977
Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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