Phase 1/2 Trial to Evaluate the Safety and Efficacy of PEEL-224 in Combination With Vincristine a… (NCT06709495) | Clinical Trial Compass
RecruitingPhase 1/2
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
United States63 participantsStarted 2025-01-27
Plain-language 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)
Who can participate
Age range
12 Years – 49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
Patients in all cohorts must have relapsed or refractory disease after standard therapy.
Patients must have:
-Hematologic Requirements for Subjects with Bone Marrow Involvement by Disease:
-Adequate Renal Function: Creatinine clearance or radioisotope GFR ≥70ml/min/1.73 m2 or A serum creatinine based on age/sex as follows:
--≥ 16 years, Maximum Serum Creatinine (mg/dL): Male 1.7, Female 1.4
-Adequate Liver Function:
Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy except organ function as noted above. Patients must meet the following minimum washout periods prior to enrollment:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Tolerated Dose (MTD) (Phase 1)
Timeframe: Up to 35 days
2
Number of Participants with Dose-Limiting Toxicities (Phase 1)
Timeframe: Up to 35 days
3
Number of Participants with DLTs (Phase 2)
Timeframe: Up to 35 days
4
Objective Response Rate EWS Cohort (Phase 2)
Timeframe: Up to 5 years (based on accrual duration of 2 years)
5
Objective Response Rate DSRCT Cohort (Phase 2)
Timeframe: Up to 5 years (based on accrual duration of 2 years)
For patients with metastatic disease to the CNS enrolling to the phase 1 portion of the trial or the "other sarcoma" cohort, any baseline neurologic deficits (including seizure) must be stable for at least one week prior to study enrollment. Patients with CNS metastatic disease receiving corticosteroids must be on a stable or decreasing dose at time of study entry.