Clinical trialNCT06709495RecruitingPhase 1/PHASE2Interventional

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

SponsorDavid S Shulman, MDEnrollment63Desmoplastic Small Round Cell TumorOsteosarcomaRefractory SarcomaRhabdomyosarcomaSarcomaSarcoma, Ewing

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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)

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

David Shulman, MD
Dana-Farber Cancer Institute
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

3 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Boston Children'S Hospital
Boston, Massachusetts, United States
David Shulman, MD
Not, yet, recruiting
Brigham and Women'S Hospital
Boston, Massachusetts, United States
David Shulman, MD
Not, yet, recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
David Shulman, MD
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Filgrastim →PEEL-224 →Pegfilgrastim →Temozolomide →Vincristine →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 27 Jan 2025
Primary completion: 1 Nov 2028
Completion: 1 Sept 2029
Last update posted: 19 Feb 2026
Registered enrollment: 63
Registry id: NCT06709495

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.