Study on PEEL-224, Vincristine, and Temozolomide for Treating Pediatric Solid Tumors

Sponsor: Theodore Laetsch

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06721689

Provider View

This clinical trial is testing a new treatment using PEEL-224, alone or with vincristine and temozolomide, to find the best dose and see how well it works in children with certain solid tumors that have not responded to previous treatments or have returned.

Patient Parameters

Program Overview

The study aims to determine the best dose of PEEL-224, a new drug, when used alone or with vincristine and temozolomide, for treating children with solid tumors that have not responded to previous treatments or have come back. The trial will also evaluate how effective this combination is in shrinking tumors in children with neuroblastoma and rhabdomyosarcoma.

Description

This study involves two phases. In Phase 1, researchers will find the best dose of PEEL-224, either alone or with vincristine and temozolomide, in children aged 1 to 18 with solid tumors that have not responded to treatment or have returned. Phase 2 will focus on children with neuroblastoma and rhabdomyosarcoma to see how well the treatment works. Participants will receive the treatment in cycles, with PEEL-224 given on specific days, and will be monitored closely for side effects and how well the cancer responds. The study will take place at multiple pediatric cancer centers, and participants can continue treatment for up to 24 cycles if it is effective and well-tolerated. Regular check-ups and tests will be conducted to track progress and health.

Eligibility Criteria

Inclusion Criteria

  • Children aged 1 to 18 years for Phase 1, and up to 30 years for neuroblastoma in Phase 2.
  • Diagnosed with solid tumors that have not responded to previous treatments or have returned.
  • Must have measurable disease as per specific criteria.
  • Must provide a tumor sample if available.
  • Good overall health with specific performance status scores.
  • Females must have a negative pregnancy test.
  • Adequate blood cell counts and organ function.
  • Must have recovered from previous treatments and meet specific timeframes since last treatments.
  • Must agree to use effective birth control during and after the study.
  • Must agree to use sun protection during and after treatment.
  • Parental or guardian consent and child assent if applicable.

Exclusion Criteria

  • Previous treatment with PEEL-224.
  • Currently receiving other cancer treatments.
  • Have primary or metastatic brain tumors.
  • Have had a stem cell or organ transplant.
  • Pregnant or breastfeeding.
  • Have a history of HIV, hepatitis B, or hepatitis C.
  • Have symptomatic heart failure.

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