OncoMatch/Clinical Trials/NCT06709495
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
Is NCT06709495 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for sarcoma.
Treatment: PEEL-224 · Temozolomide · Vincristine · Pegfilgrastim · Filgrastim — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Osteosarcoma
Rhabdomyosarcoma
Biomarker criteria
Required: EWSR1 fusion with FLI1
EWSR1::FLI1
Required: EWSR1 fusion with ERG
EWSR1::ERG
Required: EWSR1 fusion with ETV1
EWSR1::ETV1
Required: EWSR1 fusion with ETV4
EWSR1::ETV4
Required: EWSR1 fusion with FEV
EWSR1::FEV
Required: FUS fusion with FLI1
FUS::FLI1
Required: FUS fusion with ERG
FUS::ERG
Required: EWSR1 fusion with WT1
EWSR1::WT1 fusion
Prior therapy
Must have received: standard therapy
relapsed or refractory disease after standard therapy
Cannot have received: PEEL-224 (PEEL-224)
Patients who have received prior treatment with PEEL-224
Lab requirements
Blood counts
ANC ≥ 1,000/uL and platelets ≥100,000/uL (no BM involvement); ANC ≥750/uL and platelets ≥50,000/uL (BM involvement)
Kidney function
Creatinine clearance or radioisotope GFR ≥70ml/min/1.73 m2 or age/sex-based serum creatinine thresholds
Liver function
Bilirubin ≤ 1.5 x ULN for age; SGPT (ALT) ≤110 U/L (ULN for SGPT is 45 U/L)
Cardiac function
QTc < 480 msec
Adequate Bone Marrow Function...Adequate Renal Function...Adequate Liver Function...Adequate Cardiac Function: QTc < 480 msec
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Boston Children's Hospital · Boston, Massachusetts
- Dana-Farber Cancer Institute · Boston, Massachusetts
- Brigham and Women's Hospital · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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