RecruitingPhase 1Phase 2NCT06709495

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


Sponsor

David S Shulman, MD

Enrollment

63 participants

Start Date

Jan 27, 2025

Study Type

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

Min Age: 12 YearsMax Age: 49 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1/2 study is testing a new drug called PEEL-224 combined with two chemotherapy drugs (vincristine and temozolomide) in teenagers and young adults with sarcomas — bone and soft tissue cancers — that have returned or stopped responding to standard treatment. **You may be eligible if...** - Your sarcoma has relapsed or is no longer responding to standard therapy - For Phase 1: you have any type of sarcoma with measurable or detectable disease - For Phase 2 (Ewing sarcoma group): you have confirmed Ewing sarcoma with a specific genetic translocation and measurable disease - For Phase 2 (DSRCT group): you have confirmed desmoplastic small round cell tumor with measurable disease **You may NOT be eligible if...** - Your sarcoma has not yet failed standard treatment - You do not have measurable disease - You have conditions that make the combination treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT06709495


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