Actively Recruiting
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
Led by David S Shulman, MD · Updated on 2026-02-19
63
Participants Needed
3
Research Sites
239 weeks
Total Duration
On this page
Sponsors
D
David S Shulman, MD
Lead Sponsor
P
Peel Therapeutics Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have relapsed or refractory sarcoma after standard therapy.
- Phase 1: Patients must have measurable or evaluable disease and a histologic diagnosis of sarcoma.
- Phase 2 Ewing Sarcoma (EWS) cohort: Patients must have measurable disease by RECIST, histologic diagnosis of EWS, and molecular evidence of a FET-ETS family translocation.
- Phase 2 Desmoplastic Small Round Cell Tumor (DSRCT) cohort: Patients must have measurable disease by RECIST, histologic diagnosis of DSRCT, and molecular evidence of an EWSR1::WT1 fusion.
- Phase 2 Other sarcoma cohort: Patients must have evaluable or measurable disease by RECIST and a histologic diagnosis of sarcoma; includes dedicated slots for rhabdomyosarcoma, osteosarcoma, and other translocation-associated round cell sarcomas.
- Age between 12 and 49 years.
- Weight at least 40 kg.
- Karnofsky performance status at least 50% for patients older than 16 years, Lansky performance status at least 50% for patients 16 years or younger.
- Adequate bone marrow, renal, liver, and cardiac function as defined by specific blood counts, creatinine clearance, bilirubin, ALT levels, and QTc interval.
- Fully recovered from acute toxic effects of prior anti-cancer therapy with specified minimum washout periods.
- Stable neurologic status if CNS metastatic disease is present (phase 1 or other sarcoma cohort only).
- Prior or concurrent malignancies allowed if they do not interfere with study safety or efficacy.
- Women of child-bearing potential and men must agree to use contraception during and after the study.
- Ability to provide informed consent.
- Approval or agreement for oral temozolomide reimbursement.
You will not qualify if you...
- Prior treatment with PEEL-224.
- Progressive disease during irinotecan and temozolomide combination therapy (phase 2 EWS and DSRCT cohorts only).
- Receiving other anti-cancer agents for this condition.
- Use of strong P450 CYP1A2 and CYP3A4 inhibitors or inducers within 14 days before PEEL-224 dosing (except levofloxacin).
- Prior solid organ or allogeneic stem cell transplant.
- Pregnant or breastfeeding women.
- History of allergic reactions to PEGylated drugs, camptothecins, temozolomide, or vincristine.
- Uncontrolled illnesses like infection, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance.
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Trial Site Locations
Total: 3 locations
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
Research Team
D
David Shulman, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
9
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