RecruitingPhase 1Phase 2NCT06721689

PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors

A Phase 1/2 Clinical Trial of the Novel Topoisomerase I Inhibitor PEEL-224 as a Single Agent and in Combination With Vincristine and Temozolomide in Children With Refractory, Progressive or Relapsed Solid Tumors


Sponsor

Theodore Laetsch

Enrollment

59 participants

Start Date

Mar 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 1 YearMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug combination — PEEL-224, vincristine, and temozolomide — in children and young adults with solid tumors that have come back or stopped responding to prior treatment. The focus is on two specific cancers: neuroblastoma (a cancer of nerve tissue) and rhabdomyosarcoma (a cancer of muscle tissue). **You may be eligible if...** - You are between 1 and 18 years old (or up to 30 for neuroblastoma patients) - You have a solid tumor (non-brain) that has relapsed, progressed, or did not respond to at least one prior treatment - Your cancer was confirmed by biopsy at the time of original diagnosis or relapse - You have measurable or evaluable disease on imaging - Tumor tissue samples are available for testing **You may NOT be eligible if...** - Your cancer is in your brain or spinal cord - You have poor organ function (heart, liver, kidneys, lungs, or bone marrow) - You have an active, uncontrolled infection - You have had a stem cell transplant recently - You are pregnant or unwilling to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPEEL-224

PEEL-224 (PEG-\[SN22\]4) is a novel topoisomerase I inhibitor

DRUGVincristine

Vincristine is an inhibitor of microtubular formation which is approved by the Food and Drug Administration (FDA) and is commercially available.

DRUGTemozolomide (TMZ)

Temozolomide is an alkylating agent which is approved by the FDA and is commercially available.


Locations(7)

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Texas Children's Hospital

Houston, Texas, United States

University of Utah Hospital

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT06721689


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