Phase 1/2 Study of PEEL-224 with Vincristine and Temozolomide for Adolescents and Young Adults with Relapsed or Hard-to-Treat Sarcomas

Sponsor: David S Shulman, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06709495

Provider View

This clinical trial is testing a new drug, PEEL-224, combined with Vincristine and Temozolomide, to see if it can help treat certain types of sarcomas in adolescents and young adults whose cancer has returned or is not responding to standard treatments.

Patient Parameters

Program Overview

The study aims to find out if a new drug combination can effectively treat Ewing Sarcoma (EWS), Desmoplastic Small Round Cell Tumor (DSRCT), and other sarcomas. The drugs being tested are PEEL-224, Vincristine, and Temozolomide. The trial will also assess the safety of this combination and determine the best dose for future studies. Participants will undergo various tests and receive treatment for up to 34 cycles, with follow-up for a year after the last treatment.

Description

This study is testing a new drug called PEEL-224, combined with Vincristine and Temozolomide, to see if it can help treat certain types of sarcomas in adolescents and young adults whose cancer has returned or is not responding to standard treatments. The trial is divided into two phases: Phase 1 will focus on finding a safe dose, and Phase 2 will evaluate how well the treatment works. Participants will receive the treatment for up to 34 cycles, which is about two years, and will be monitored for a year after the last treatment. The study involves regular clinic visits, scans, and tests to track the cancer's response and the patient's health. About 63 people are expected to participate in this study, which is funded by PEEL Therapeutics.

Eligibility Criteria

Inclusion Criteria

  • Must have sarcoma that has returned or is not responding to standard treatments.
  • For Phase 1: Must have sarcoma that can be measured or evaluated.
  • For Phase 2: Must have specific types of sarcoma, such as Ewing Sarcoma or DSRCT, with measurable disease and specific genetic markers.
  • Must be between 12 and 49 years old and weigh at least 40 kg.
  • Must have good overall health and organ function, as determined by specific medical tests.
  • Must have recovered from previous cancer treatments and meet certain time requirements since last treatment.
  • Must agree to use effective birth control during the study and for a period after.
  • Must be able to understand and agree to the study requirements, or have a guardian who can consent on their behalf.
  • Must have insurance approval or agree to pay for oral temozolomide.

Exclusion Criteria

  • Cannot have received PEEL-224 before.
  • Cannot have had disease progression while on irinotecan and temozolomide for certain sarcoma types.
  • Cannot be taking other cancer treatments for this condition.
  • Cannot be taking certain medications that affect how PEEL-224 works.
  • Cannot have had a solid organ or stem cell transplant.
  • Cannot be pregnant or breastfeeding.
  • Cannot have allergies to the study drugs.
  • Cannot have uncontrolled health issues that would interfere with the study.

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