Clinical trialNCT06721689RecruitingPhase 1/PHASE2Interventional

PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors

SponsorTheodore LaetschEnrollment59Refractory NeuroblastomaRefractory RhabdomyosarcomaRefractory Solid TumorsRelapsed NeuroblastomaRelapsed RhabdomyosarcomaRelapsed Solid Tumors

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Jacquelyn Crane, MD
Children's Hospital of Philadelphia
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

7 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Cedars-Sinai Medical Center
Los Angeles, California, United States
Leo Mascarhenhas, MD
Recruiting
University of California, San Francisco
San Francisco, California, United States
Jennifer Michlitsch, MD
Recruiting
Boston Children'S Hospital
Boston, Massachusetts, United States
David Shulman, MD
Not, yet, recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
David Shulman, MD
Not, yet, recruiting
Children'S Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Jacquelyn Crane, MD
Recruiting
Texas Children'S Hospital
Houston, Texas, United States
Jennifer Foster, MD
Recruiting
University of Utah Hospital
Salt Lake City, Utah, United States
Matthew Dietz, MD
Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

PEEL-224 →Temozolomide →Vincristine →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 23 Mar 2025
Primary completion: 30 Apr 2030
Completion: 30 Apr 2031
Last update posted: 22 Jul 2026
Registered enrollment: 59
Registry id: NCT06721689

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.