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RECRUITING Phase 1

Phase 1/2 Trial to Evaluate the Safety and Efficacy of PEEL-224 in Combination With Vincristine and Temozolomide in Adolescents and Young Adults With Relapsed or Refractory Sarcomas

NCT06709495 · View on ClinicalTrials.gov ↗

Study Summary

This research is being done to test a new drug called PEEL-224 in combination with two commercially available drugs, Vincristine and Temozolomide, and to determine how effective this combination of drugs is at treating Ewing Sarcoma (EWS) and Desmoplastic Small Round Cell Tumor (DSRCT), as well as multiple other kinds of sarcomas. The names of the study drugs and biological agents involved in this study are: * PEEL-224 (a type of Topoisomerase 1 inhibitor) * Vincristine (A type of vinca alkaloid) * Temozolomide (A type of alkylating agent) * Pegfilgrastim or Filgrastim (types of Myeloid growth factors)

Interventions

  • DRUG Temozolomide
  • DRUG Vincristine
  • BIOLOGICAL Filgrastim
  • BIOLOGICAL Pegfilgrastim
  • DRUG PEEL-224

Study Locations (3)

Massachusetts

  • Boston Children's Hospital — Boston
  • Dana-Farber Cancer Institute — Boston
  • Brigham and Women's Hospital — Boston

Trial Details

FieldValue
Enrollment Target 63 participants
Start Date 2025-01-27
Est. Completion 2029-09-01
Phase Phase 1

Sponsor

David S Shulman, MD

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06709495

The ClinicalTrials.gov registry entry for NCT06709495 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is David S Shulman, MD, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 6 conditions, with Sarcoma appearing as the primary indexed condition, and to 5 interventions — of which Temozolomide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06709495 reports 3 study locations spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06709495 about?

NCT06709495 is a clinical study titled "Phase 1/2 Trial to Evaluate the Safety and Efficacy of PEEL-224 in Combination With Vincristine and Temozolomide in Adolescents and Young Adults With Relapsed or Refractory Sarcomas". This research is being done to test a new drug called PEEL-224 in combination with two commercially available drugs, Vincristine and Temozolomide, and to determine how effective this combination of drugs is at treating Ewing Sarcoma (EWS) and Desmoplastic Small Round Cell Tumor (DSRCT), as well as m...

What is the current status of trial NCT06709495?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2025-01-27. Estimated completion is 2029-09-01.

What conditions does trial NCT06709495 study?

This clinical trial studies the following conditions: Sarcoma, Osteosarcoma, Rhabdomyosarcoma, Desmoplastic Small Round Cell Tumor, Sarcoma, Ewing. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06709495?

The interventions under investigation include: Temozolomide (DRUG), Vincristine (DRUG), Filgrastim (BIOLOGICAL), Pegfilgrastim (BIOLOGICAL), PEEL-224 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06709495?

This trial is sponsored by David S Shulman, MD, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06709495 being conducted?

This trial has 3 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial