OncoMatch/Clinical Trials/NCT06721689
PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors
Is NCT06721689 recruiting? Yes, currently enrolling (Sep 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
Treatments studied
Chemotherapy
Other
Cancer type
Tumor Agnostic
Neuroblastoma
Rhabdomyosarcoma
Demographics
Prior therapy
Must have received: upfront therapy
have received at least 1 line of upfront therapy
Cannot have received: PEEL-224
Prior treatment with PEEL-224
Lab requirements
Blood counts
ANC ≥ 750/mm3 (phase 1/phase 2 without marrow infiltration); ANC ≥ 500/mm3 (phase 2 with marrow infiltration); platelets ≥ 75,000/mm3 (phase 1/phase 2 without marrow infiltration); platelets ≥ 50,000/mm3 (phase 2 with marrow infiltration); not refractory to packed RBC transfusions
Kidney function
Creatinine clearance by Schwartz equation or GFR ≥ 70 mL/min/1.73 m2, or age/sex-based maximum serum creatinine
Liver function
AST/SGOT ≤ 3x ULN (≤ 5x ULN if attributable to disease involvement; ULN=50 U/L); ALT/SGPT ≤ 3x ULN (≤ 5x ULN if attributable to disease involvement; ULN=45 U/L); total bilirubin ≤ 1.5x ULN (Gilbert's: <3x ULN)
Adequate bone marrow, renal, and liver function as detailed in inclusion criteria
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Cedars-Sinai Medical Center · Los Angeles, California
- University of California, San Francisco · San Francisco, California
- Boston Children's Hospital · Boston, Massachusetts
- Dana-Farber Cancer Institute · Boston, Massachusetts
- Children's Hospital of Philadelphia · Philadelphia, Pennsylvania
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06721689 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior PEEL-224 disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 30 years or younger and at least 1 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages