Actively Recruiting
PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors
Led by Theodore Laetsch · Updated on 2026-04-15
59
Participants Needed
7
Research Sites
314 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
The phase 1 primary objective is to determine the pediatric recommended phase 2 dose (RP2D) of PEEL-224 as a single agent (phase 1A) and in combination with vincristine and temozolomide (phase 1B). The phase 2 primary objective is to estimate the objective response rate (ORR) in children with refractory, progressive and relapsed NBL and rhabdomyosarcoma (RMS) treated with the RP2D of PEEL-224 in combination with vincristine and temozolomide.
CONDITIONS
Official Title
PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 1-18 years for phase 1 and rhabdomyosarcoma cohort; age 1-30 years for neuroblastoma cohort in phase 2
- Diagnosis of refractory, progressive, or relapsed non-central nervous system solid tumors for phase 1
- Diagnosis of refractory, progressive, or relapsed neuroblastoma or rhabdomyosarcoma for phase 2
- Histologic verification of malignancy at original diagnosis or relapse
- Evaluable or measurable disease as defined by study criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 if older than 16 years or Lansky Performance Status at least 60 if younger than 16 years
- Negative pregnancy test for females of childbearing potential
- Adequate bone marrow function with specific blood count thresholds and time since last growth factor or transfusion
- Adequate kidney function based on creatinine clearance or serum creatinine levels adjusted for age and sex
- Adequate liver function within specified enzyme and bilirubin limits
- Resolution of acute toxic effects from prior therapy to grade 1 or less except certain controlled symptoms
- Minimum washout periods from prior therapies including chemotherapy, targeted agents, antibody therapy, cellular therapy, stem cell transplant, growth factors, radiotherapy, radiopharmaceutical therapy, major surgery, and CYP inhibitors/inducers
- Prior treatment with irinotecan and/or temozolomide allowed
- Agreement to use effective contraception during and for six months after treatment
- Agreement to use sun protection during treatment and for 4 weeks after
- Informed consent from patient or guardian and assent if appropriate
You will not qualify if you...
- Prior treatment with PEEL-224
- Receiving any other anti-cancer agents during the study
- Primary central nervous system solid tumors or CNS metastatic disease
- Prior allogeneic stem cell or solid organ transplant
- Pregnant or lactating females
- Known HIV, hepatitis B, or hepatitis C infection
- Symptomatic congestive heart failure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
J
James Robinson, MSW, MPH
CONTACT
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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