Actively Recruiting
A Phase 1/2 Trial of PEEL-224 Alone and With Vincristine and Temozolomide in Children With Refractory, Progressive, or Relapsed Solid Tumors
Led by Theodore Laetsch · Updated on 2026-04-15
59
Participants Needed
7
Research Sites
52 weeks
Total Duration
On this page
Sponsors
T
Theodore Laetsch
Lead Sponsor
P
Peel Therapeutics Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new drug called PEEL-224 in children with difficult-to-treat or returning solid tumors, including neuroblastoma (NBL) and rhabdomyosarcoma (RMS). The study is split into two phases: Phase 1 aims to find a safe and recommended dose of PEEL-224 alone and combined with vincristine and temozolomide. Phase 2 then looks at how well this combination works in children with these specific cancers. In Phase 1A, PEEL-224 is given by itself on days 1 and 8 of a 21-day cycle to children aged 1 to 18 with solid tumors that have not responded to treatment. Phase 1B and Phase 2 involve giving PEEL-224 with vincristine on days 1 and 8 and temozolomide on days 1 to 5 of each cycle. Participants may stay on treatment for up to 24 cycles, or about 18 months, unless the disease worsens or side effects become too severe. Participants will have regular physical exams and lab tests on days 1 and 8 of each treatment cycle. Disease response and patient-reported outcomes are assessed after cycles 2, 4, 6, 9, 12, 18, and 24. In Phase 1, blood samples will be taken to study how the drug moves through the body. The main goals are to find the dose-limiting side effects in Phase 1 and to measure tumor response in Phase 2.
CONDITIONS
Brief Title
PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 1 to 18 years for Phase 1 and Phase 2 Rhabdomyosarcoma cohort
- Age 1 to 30 years for Phase 2 Neuroblastoma cohort
- Diagnosis of refractory, progressive, or relapsed non-CNS solid tumors for Phase 1
- Diagnosis of refractory, progressive, or relapsed neuroblastoma or rhabdomyosarcoma for Phase 2
- Histologic verification of malignancy at diagnosis or relapse
- Evaluable or measurable disease (specific criteria for NBL and RMS in Phase 2)
- ECOG performance status 0-2 (age >16 years) or Lansky score ≥60 (age <16 years)
- Negative pregnancy test for females of childbearing potential
- Adequate bone marrow, renal, and liver function as specified
- Resolution of acute toxic effects of prior therapy to grade ≤1 (with exceptions)
- Minimum washout periods from prior therapies as specified
- Prior irinotecan and/or temozolomide treatment allowed
- Agreement to use effective contraception during and for 6 months after treatment
- Agreement to use sun protection during and 4 weeks after treatment
- Parental/guardian permission and child assent as appropriate
You will not qualify if you...
- Prior treatment with PEEL-224
- Receiving any other anti-cancer agents
- Primary CNS solid tumors or CNS metastatic disease
- Prior allogeneic stem cell or solid organ transplant
- Pregnant or lactating females
- Known history of HIV, hepatitis B or C
- Symptomatic congestive heart failure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 cycles (approximately 18 months)
Participants receive PEEL-224 alone or in combination with vincristine and temozolomide in repeated 21-day cycles to treat refractory, progressive, or relapsed solid tumors. Treatment continues for up to 24 cycles (approximately 18 months) if there is no disease progression or unacceptable toxicity.
Visits on days 1 and 8 of each 21-day cycle; disease assessments after cycles 2, 4, 6, 9, 12, 18, and 24
Duration - Up to 2 years
After treatment ends, participants are monitored for safety and disease response to assess long-term outcomes and adverse events.
Periodic visits for disease response and safety monitoring
Trial Site Locations
Total: 7 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Not Yet Recruiting
2
University of California, San Francisco
San Francisco, California, United States, 94143
Not Yet Recruiting
3
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
5
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
6
Texas Children's Hospital
Houston, Texas, United States, 77030
Not Yet Recruiting
7
University of Utah Hospital
Salt Lake City, Utah, United States, 84132
Not Yet Recruiting
Research Team
M
Meghan Donnelly, MPH
J
James Robinson, MSW, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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