Recruiting PHASE2, PHASE3 High-Risk Neuroblastoma

Tests treatment safety and results for High-Risk Neuroblastoma

Official title A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients

ClinicalTrials.gov ID: NCT07549321

What this study is testing

What is hu1418K322A + Temozolomide + Irinotecan?

hu1418K322A + Temozolomide + Irinotecan is an investigational medicine, being studied as a potential treatment for high-risk neuroblastoma.

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
Neuroblastoma is the most common type of solid cancer found outside the brain in young children. Generally, it affects children younger than 5 years old, with the average age when it is found being just 2 years.
  • Phase 3: a large, late-stage study
  • This is a blinded study.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 18

You may be able to join if

  • Are ≥18 months to \<18 years of age at time of informed consent or assent.
  • Are initially diagnosed with histologically proven HRNB with metastatic disease.
  • Have evaluable or measurable disease per International Neuroblastoma Response Criteria (INRC)
  • Have a Lansky performance status of ≥50 (≤16 years ) or Karnofsky performance status ≥50% (for \>16 years).
  • Have recovered from the toxic effects of prior chemotherapies

You likely can't join if

  • Any active uncontrolled infection at the time of enrollment. Any known history of infection with human immunodeficiency virus (HIV), or active or...
  • Any contraindications to any of the study treatments.
  • Patients with \>Grade 2 diarrhea.
  • Patients with disease of any major organ system that would compromise their ability to withstand chemoimmunotherapy.
  • Patients who have undergone a prior allogeneic stem cell transplant \< 6 months ago or have undergone a solid organ transplant.
  • Patients who are on hemodialysis.
See the full eligibility criteria
Who can join
  • Are ≥18 months to \<18 years of age at time of informed consent or assent.
  • Are initially diagnosed with histologically proven HRNB with metastatic disease.
  • Have evaluable or measurable disease per International Neuroblastoma Response Criteria (INRC)
  • Have a Lansky performance status of ≥50 (≤16 years ) or Karnofsky performance status ≥50% (for \>16 years).
  • Have recovered from the toxic effects of prior chemotherapies
  • Are at least 2 weeks beyond any major tumor surgery
  • Meet the following organ function criteria, as measured within 1 week prior to Investigational Medicinal Product (IMP) dosing:
  • BM function: i. Platelets ≥50 × 109/L ii. Absolute neutrophil count (ANC) ≥0.50 × 109/L
  • Renal function: i. Age-adjusted serum creatinine ≤1.5 × upper limit of normal (ULN) for age. ii. Estimated glomerular filtration rate (eGFR) at least 60 mL/min using the Schwartz formula.
  • Liver function: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3 × ULN and total bilirubin ≤1.5 × ULN.
  • Cardiac function: i. Shortening fraction ≥27% or ejection fraction of ≥50% on echocardiogram. ii. Corrected QT Interval on electrocardiogram (ECG) using the Fridericia formula (QTcF) ≤ 480 msec.
  • Lung function: i. Pulse oximetry considered normal in room air. No evidence of dyspnea at rest.
  • Central nervous system (CNS) function: i. Participants with a history of CNS disease must have no clinical or radiological evidence of active CNS disease at the time of study enrollment.
  • If a fertile and sexually active woman of child-bearing potential (WOCBP), have a negative serum pregnancy test at Screening and then either a negative serum or urine test prior to each cycle and agree to use an...
  • If a fertile and sexually active male, agree to use condoms during the study and for at least 6 months after the last dose of study treatment
  • If applicable based on age, are willing and able to provide voluntary written informed assent for participation in the study (as per local Institutional Review Board [IRB]/Independent Ethics Committee [IEC] requirements...
  • Their parent or legal guardian (if applicable based on regional age of consent) is willing and able to provide voluntary written informed consent for the participant's involvement in the study.
What rules you out
  • Any active uncontrolled infection at the time of enrollment. Any known history of infection with human immunodeficiency virus (HIV), or active or chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
  • Any contraindications to any of the study treatments.
  • Patients with \>Grade 2 diarrhea.
  • Patients with disease of any major organ system that would compromise their ability to withstand chemoimmunotherapy.
  • Patients who have undergone a prior allogeneic stem cell transplant \< 6 months ago or have undergone a solid organ transplant.
  • Patients who are on hemodialysis.
  • Patients who require or are likely to require pharmacologic doses of systemic corticosteroids while receiving treatment on this study except to manage allergic reactions
  • Patients on any other immunosuppressive medications
  • Patients who have received enzyme-inducing anticonvulsants including phenytoin, phenobarbital, or carbamazepine for at least 7 days prior to study enrollment.
  • Patients who have been diagnosed with any malignancy other than neuroblastoma.
  • Patients with symptoms of congestive heart failure.
  • Patients with a history of Grade 4 allergic reactions to anti-GD2 antibodies or reactions that required permanent discontinuation of the anti-GD2 therapy.
  • Patients participating in or planning to participate in another study that is either blinded or involves an IMP
  • If female, are breastfeeding, pregnant, or planning to become pregnant, or, if sexually active and of child-bearing potential, are unwilling to use an effective birth control method until 6 months after the last dose of...
  • Do not meet the following required washout periods prior to the administration of the first dose of hu14.18K322A:
  • 14 days from prior systemic myelosuppressive chemotherapy.
  • 7 days from prior systemic biologic antineoplastic agents (e.g. anti-cancer agents not known to be myelosuppressive - not associated with reduced platelet or ANC counts).
  • 14 days from systemic steroids.
  • ≥12 weeks from large field radiation therapy (i.e., total body irradiation, whole abdominal, total lung, ≥50% pelvis).
  • 6 weeks from prior craniospinal radiotherapy or Iodine-131-metaiodobenzylguanidine (131I-MIBG) therapy.
  • 2 weeks from radiotherapy to the primary tumor bed.
  • ≥7 days from small treatment field radiation.
  • 14 days or 5 half-lives (whichever is longer) from last administration of an IMP.
  • \>7 days prior to study enrollment for drugs that are strong inducers or inhibitors of Cytochrome P450 3A4 (CYP3A4).
  • ≥21 days and with recovery of all associated toxicities from receiving cellular therapy (e.g., modified T lymphocyte cells, Natural Killer (NK) cells, dendritic cells).
  • Ongoing need for any medication known or suspected to interfere with study treatment.

The study team makes the final eligibility decision.

Where it's taking place

  • Aurora, Colorado, United States
  • Minneapolis, Minnesota, United States
  • The Bronx, New York, United States
  • Durham, North Carolina, United States
  • Philadelphia, Pennsylvania, 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, 18 months to 18 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Aurora, Colorado, United States; Minneapolis, Minnesota, United States; The Bronx, New York, United States; Durham, North Carolina, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.

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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.