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NCT06709495 · ClinicalTrials.gov registry record · 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

A Phase 1 study of Sarcoma and Osteosarcoma, sponsored by David S Shulman, MD.

Recruiting
Registry status
Phase 1
Development phase
63
Enrollment target
3
Study locations

NCT06709495 is a Phase 1 study of Sarcoma and Osteosarcoma that is actively recruiting participants, run by David S Shulman, MD. The registered enrollment target is 63 participants, below the 921-participant average among 122 other Sarcoma trials with a reported enrollment target (93% lower). The trial reports 3 study locations across 1 state.

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The verdict

NCT06709495, a Phase 1 study of Sarcoma and Osteosarcoma, is actively recruiting participants, sponsored by David S Shulman, MD.

RECRUITING
Registry status
Phase 1
Development phase
63 participants
Enrollment target
3
Study locations

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)

Conditions Studied

Sarcoma Osteosarcoma Rhabdomyosarcoma Desmoplastic Small Round Cell Tumor Sarcoma, Ewing Refractory Sarcoma

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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What the Registry Record Tells You About NCT06709495

The ClinicalTrials.gov registry entry for NCT06709495 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 921-participant average among 122 other Sarcoma trials with a reported enrollment target (93% lower). The listed sponsor is David S Shulman, MD, which has 1 total studies on file at ClinicalTrials.gov.

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.

NCT06709495 reports 3 study locations spanning 1 distinct geographic area - top geographies include Massachusetts.

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.

What interventions are being tested in trial NCT06709495?

The interventions under investigation include: Temozolomide (DRUG), Vincristine (DRUG), Filgrastim (BIOLOGICAL), Pegfilgrastim (BIOLOGICAL), PEEL-224 (DRUG).

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.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.