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New treatment option for Refractory Solid Tumors
Official title PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors
ClinicalTrials.gov ID: NCT06721689
What this study is testing
What is PEEL-224?
PEEL-224 is an investigational medicine, being studied as a potential treatment for refractory solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 30
You may be able to join 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:
You likely can't join if
- Prior treatment with PEEL-224.
- people receiving any other anti-cancer agents.
- people with primary central nervous system (CNS) solid tumors or central nervous system (CNS) metastatic disease.
- people with prior allogeneic stem cell or solid organ transplantation.
- Pregnant or lactating females.
- people with a known history of human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C (testing not required as part of screening).
See the full eligibility criteria
Who can join
- 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...
- 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...
- Disease status:
- Phase 1: evaluable or measurable disease
- Phase 2, people with Neuroblastoma (NBL): evaluable or measurable disease by International Neuroblastoma Response Criteria (INRC); people with only bone marrow disease are not eligible
- Phase 2, people 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 people on phase 1 and people 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...
- 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 people 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...
- 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...
- Adequate liver function
- 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...
- 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...
- 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).
- 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...
- 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: people 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...
- Prior treatment with irinotecan and/or temozolomide is permitted.
- 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...
- people must agree to use sun protective measures while receiving treatment and for 4 weeks after the last dose of PEEL-224
- Parental/guardian permission (informed consent) and if appropriate, child assent.
What rules you out
- Prior treatment with PEEL-224.
- people receiving any other anti-cancer agents.
- people with primary central nervous system (CNS) solid tumors or central nervous system (CNS) metastatic disease.
- people with prior allogeneic stem cell or solid organ transplantation.
- Pregnant or lactating females.
- people with a known history of human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C (testing not required as part of screening).
- people with symptomatic congestive heart failure.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- Boston, Massachusetts, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; Boston, Massachusetts, United States; Philadelphia, Pennsylvania, United States; Houston, Texas, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.