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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: Recruiting Phase 1 study of Sarcoma and Osteosarcoma, sponsored by David S Shulman, MD.
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. According to ClinicalTrials.gov, the official US trial registry.
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)
Primary Outcome
The MTD is determined by a Continual Reassessment Method (CRM) design and defined as the dose level with the posterior probability of dose-limiting toxicity (DLT) closest to the target toxicity rate of 0.3 with a maximum sample size of 15. The DLT observation period is up to 35 days long, beginning at the first dose of any of the three drugs in cycle 1 and ending at the occurrence of a DLT.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2025-01-27 |
| Est. Completion | 2029-09-01 |
| Phase | Phase 1 |
What NCT06709495 shows while recruiting
NCT06709495 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 921-participant average among 122 other Sarcoma trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Sarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06709495's enrollment target sits among peer trials
63 58th of 122 higher than 65 of 122 other Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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