OncoMatch/Clinical Trials/NCT06721689
PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors
Is NCT06721689 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including PEEL-224 and Vincristine for refractory solid tumors.
Treatment: PEEL-224 · Vincristine · Temozolomide (TMZ) — The phase 1 primary objective is to determine the pediatric recommended phase 2 dose (RP2D) of PEEL-224 as a single agent (phase 1A) and in combination with vincristine and temozolomide (phase 1B). The phase 2 primary objective is to estimate the objective response rate (ORR) in children with refractory, progressive and relapsed NBL and rhabdomyosarcoma (RMS) treated with the RP2D of PEEL-224 in combination with vincristine and temozolomide.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Neuroblastoma
Rhabdomyosarcoma
Prior therapy
Must have received: upfront therapy
who have received at least 1 line of upfront therapy
Cannot have received: PEEL-224 (PEEL-224)
Prior treatment with PEEL-224.
Lab requirements
Blood counts
Phase 1 and phase 2 without malignant BM infiltration: ANC ≥ 750/mm3, platelets ≥ 75,000/mm3, not refractory to PRBC transfusions. Phase 2 with malignant BM infiltration: ANC ≥ 500/mm3, platelets ≥ 50,000/mm3, not refractory to PRBC transfusions.
Kidney function
Creatinine clearance by Schwartz equation, radioisotope GFR ≥ 70 mL/min/1.73 m2, or age/sex-based maximum serum creatinine
Liver function
AST/SGOT ≤ 3x ULN or ≤ 5x ULN if attributable to disease involvement (ULN for AST is 50 U/L); ALT/SGPT ≤ 3x ULN or ≤ 5x ULN if attributable to disease involvement (ULN for ALT is 45 U/L); Total bilirubin ≤ 1.5x ULN (Gilbert's syndrome: <3x ULN)
Adequate bone marrow function...Adequate renal function as evidenced by creatinine clearance as calculated by the Schwartz equation...Adequate liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital of Philadelphia · Philadelphia, Pennsylvania
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