PEEL-224, Vincristine, and Temozolomide for Pediatric Solid Tumors
This study is testing a new drug called PEEL-224, alone and in combination with two approved drugs, vincristine and temozolomide. It's for children and young adults (ages 1 to 30 years, depending on the phase) with solid tumors that have returned or are not responding to treatment, specifically neuroblastoma and rhabdomyosarcoma. The study aims to find the safest dose of PEEL-224 and see how well the combination treatment shrinks tumors. The study status is currently unclear.
- Study design
- This is an interventional study with a planned enrollment of 59 participants. It has two phases: Phase 1 (1A and 1B) to find the right dose, and Phase 2 to see how well the treatment works in specific tumor types.
- What's involved
- You would receive PEEL-224, vincristine, and temozolomide in 21-day cycles, potentially for up to 24 cycles (about 18 months). You would have physical exams and lab tests on days 1 and 8 of each cycle, and tumor assessments after cycles 2, 4, 6, 9, 12, 18, and 24.
- Compensation
- Not stated in the trial record.
- Follow-up
- For Phase 2, the study will measure how well the treatment works for up to 2 years.
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NCT06721689
PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors
Recruiting
PHASE1Ages 1–30InterventionalTreatmentTheodore LaetschInvestigator-initiated
~59 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:PEEL-224VincristineTemozolomide (TMZ)
At a glance
Recruiting sites
4 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1A and Phase 1B: Number of participants who experience a dose limiting toxicity (DLT)
Measured over 1 month
+2 more outcomes measured
Conditions
Where it's being run
7 sites across 5 statesCalifornia2
Massachusetts2
Pennsylvania1
Texas1
Utah1
Study leadership
- Jacquelyn Crane, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Phase 1: Age greater than or equal to 1 year and less than or equal to18 years
Phase 2 Neuroblastoma (NBL) cohort: Age greater than or equal to 1 year and less than or equal to 30 years
Phase 2 Rhabdomyosarcoma (RMS) cohort: Age greater than or equal to 1 year and less than or equal to18 years 2. Diagnosis of:
Phase 1: Refractory, progressive or relapsed non-central nervous system (CNS) solid tumors who have received at least 1 line of upfront therapy. Patients must have had histologic verification of their malignancy at original diagnosis or relapse
Phase 2: Refractory, progressive or relapsed neuroblastoma (NBL) or rhabdomyosarcoma (RMS) who have received at least 1 line of upfront therapy. Patients must have had histologic verification of their malignancy at original diagnosis or relapse. 3. Disease status:
Phase 1: evaluable or measurable disease
Phase 2, subjects with Neuroblastoma (NBL): evaluable or measurable disease by International Neuroblastoma Response Criteria (INRC); subjects with only bone marrow disease are not eligible
Phase 2, subjects with rhabdomyosarcoma (RMS): measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)1.1. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 (age greater than 16 years) or Lansky Performance Status of at least 60 (age less than 16 years). 5. Females of childbearing potential must have a negative urine/serum pregnancy test. 6. Adequate bone marrow function
Absolute neutrophil count (ANC) greater than or equal to 750/mm3 (greater than or equal to 7 days since last dose of short acting myeloid growth factor medications (e.g. filgrastim) and greater than or equal to 14 days since last dose of long-acting myeloid medications (e.g. peg-filgrastim)
Platelet count ≥ 75,000 mm3 (greater than or equal to 14 days since last dose of thrombopoietin receptor agonist such as romiplostim and without platelet transfusion within previous 7 days)
Not refractory to packed red blood cell transfusions
Absolute neutrophil count (ANC) greater than or equal to 500/mm3 (greater than or equal to 7 days since last dose of short acting myeloid growth factor medications (e.g. filgrastim) and greater than or equal to 14 days since last dose of long-acting myeloid medications (e.g. peg-filgrastim))
Platelet count greater than or equal to 50,000/mm3 (greater than or equal to 14 days since last dose of thrombopoietin receptor agonist such as romiplostim and without platelet transfusion within previous 7 days)
Not refractory to packed red blood cell transfusions
Patients on phase 2 with malignant infiltration of the bone marrow will not be evaluable for hematologic toxicity. 7. Adequate renal function as evidenced by creatinine clearance as calculated by the Schwartz equation (see below), radioisotope glomerular filtration rate (GFR) greater than or equal to 70 mL/min/1.73 m2, or maximum serum creatinine as below:
Aspartate Aminotransferase (AST/SGOT): less than or equal to 3 times the upper limit of normal (ULN) or less than or equal to 5 the upper limit of normal if attributable to disease involvement. For the purpose of this study, the upper limit of normal (ULN) for Aspartate Aminotransferase (AST) is 50 U/L.
Alanine Aminotransferase (ALT/SGPT): less than or equal to 3 times the ULN or less than or equal to 5 the upper limit of normal if attributable to disease involvement. For the purpose of this study, the upper limit of normal (ULN) for Alanine Aminotransferase (ALT) is 45 U/L.
Total bilirubin: less than or equal to 1.5 times the upper limit of normal with the exception of patients with Gilbert's syndrome who must have bilirubin less than 3X institutional upper limit of normal (ULN). 9. Prior Therapy: Patients must have had resolution of acute toxic effects of prior therapy to grade less than or equal to 1 according to the National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v 5.0 except organ function as noted above, adverse events (AE) that are considered clinically non-significant (i.e. alopecia), or controlled on supportive care (i.e. nausea/vomiting, hypothyroidism). Patients must meet the following minimum washout periods prior to enrollment:
Myelosuppressive chemotherapy: At least 14 days after the last dose of myelosuppressive chemotherapy
Small molecule targeted therapy: At least 7 days following the last dose of a small molecule targeted agent.
Antibody therapy: At least 21 days following the last dose of antibody including anti-GD2 monoclonal antibody.
Cellular therapy: At least 42 days following completion of a cellular therapy agent (e.g. modified T cells, NK cells, dendritic cells)
Autologous hematopoietic stem cell transplant and stem cell boost: Subjects must be at least 60 days from day 0 of an autologous stem cell transplant or stem cell boost.
Myeloid growth factors: At least 7 days following short-acting myeloid growth factor (e.g. filgrastim) and at least 14 days following the last dose of long-acting myeloid growth factor (e.g. peg-filgrastim)
Thrombopoietin receptor agonists: At least 14 days following last dose of thrombopoietin receptor agonist such as romiplostim
Interleukins, interferons, and cytokines (other than hematopoietic growth factors): At least 21 days following the completion of interleukins, interferon, or cytokines, including IL-2
Radiotherapy:
At least 14 days after limited field radiation therapy;
At least 90 days after total body irradiation, craniospinal radiotherapy; or radiation to greater than 50% of pelvis;
At least 42 days must have elapsed if other substantial BM radiation.
Radiopharmaceutical therapy (e.g. radiolabeled antibody, 131I- MIBG): At least 42 days after radiopharmaceutical therapy
Major Surgery: At least 2 weeks from prior major surgical procedure. Note: Biopsy, CNS shunt placement/revision, and central line placement/removal are not considered major.
Strong CYP1A2 and/or CYP3A4 inhibitors and/or inducers: At least 14 days following use of a strong CYP1A2 and/or CYP3A4 inhibitor and/or inducer. See Appendix 1 for examples. (Note that levofloxacin is permitted when clinically indicated) 10. Prior treatment with irinotecan and/or temozolomide is permitted. 11. Female patients of reproductive potential must agree to use a highly effective contraceptive method for the duration of study therapy and for at least six months after the final dose of PEEL-224. Males of reproductive potential with a female partner of child-bearing potential must use a highly effective for the duration of the study and for at least six months after the final dose of PEEL-224. 12. Subjects must agree to use sun protective measures while receiving treatment and for 4 weeks after the last dose of PEEL-224 13. Parental/guardian permission (informed consent) and if appropriate, child assent.
What this trial measures
- Phase 1A and Phase 1B: Number of participants who experience a dose limiting toxicity (DLT)1 month
The observation of a dose-limiting toxicity (DLT) or lack of observation of DLT in the period between treatment initiation up to initiation of cycle 2 treatment. A dose limiting toxicity (DLT) describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
- Phase 2 Neuroblastoma Cohort (NBL): Number of paricptants who achieve a complete response (CR), partial response (PR), or minor response (MR)2 years
Objective response as assessed by the Revised International Neuroblastoma Response Criteria (INRC). Response is defined as complete response (CR), partial response (PR) or minor response (MR), using best response measured at any point prior to local control.
- Phase 2 Rhabdomyosarcoma (RMS) Cohort: Number of participants who achieve a complete response (CR) or partial response (PR)2 years
Objective response as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Response is defined as complete response (CR) or partial response (PR), using best response measured at any point prior to local control.