PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Refractory Solid Tumors, Relapsed Solid Tumors, Relapsed Neuroblastoma, Refractory Neuroblastoma, Relapsed Rhabdomyosarcoma, Refractory Rhabdomyosarcoma

In brief

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.

Key facts

Study ID: NCT06721689
Run by: Theodore Laetsch
People needed: 59
Starts: 2025-03-23
Expected to finish: 2031-04-01
Last updated by the study team: 2026-07-22

Who can join

Age: 1 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age:
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
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.
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.
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).
Females of childbearing potential must have a negative urine/serum pregnancy test.
Adequate bone marrow function
Hematologic requirements for all subjects on phase 1 and subjects on phase 2 without malignant infiltration of the bone marrow:
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
Hematologic requirements for subjects on phase 2 with malignant infiltration of the bone marrow:
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.
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:
Age Maximum Serum Creatinine (mg/dL)

You may not qualify if…

Prior treatment with PEEL-224.
Subjects receiving any other anti-cancer agents.
Subjects with primary central nervous system (CNS) solid tumors or central nervous system (CNS) metastatic disease.
Subjects with prior allogeneic stem cell or solid organ transplantation.
Pregnant or lactating females.
Subjects with a known history of human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C (testing not required as part of screening).
Subjects with symptomatic congestive heart failure.

Where it is running

Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
Texas Children's Hospital — Houston, Texas, United States (enrolling)
University of California, San Francisco — San Francisco, California, United States (enrolling)
Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Boston Children's Hospital — Boston, Massachusetts, United States
University of Utah Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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