Study on Tipifarnib and Naxitamab for Treating Relapsed or Hard-to-Treat Neuroblastoma

Sponsor: Giselle Sholler

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06540963

Provider View

This clinical trial is testing a new combination of drugs, tipifarnib and naxitimab, to see if they are safe and effective for patients with neuroblastoma that has returned or is not responding to treatment.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of a new drug, tipifarnib, taken as a pill, combined with naxitimab, an FDA-approved drug given through an IV. Naxitimab is approved for children and adults with high-risk neuroblastoma in the bones or bone marrow that has returned or not responded to previous treatments. This study will test if the combination of these drugs can help control the disease and how long patients can live without the disease getting worse.

Eligibility Criteria

Inclusion Criteria

  • Must be 21 years old or younger at initial diagnosis and over 12 months old at enrollment. The first 6 participants must be 6 years or older.
  • Must have a confirmed diagnosis of neuroblastoma at any point in treatment.
  • Disease assessment must be done within 4 weeks before starting the study drug.
  • Must have relapsed or refractory neuroblastoma, meaning the cancer has returned after treatment or has not responded to treatment.
  • Must have measurable or evaluable disease, such as a tumor larger than 10mm on a scan or a positive bone marrow test.
  • If taking steroids for CNS disease, must be on a stable dose for at least one week before biopsy and not have worsening hydrocephalus.
  • Must have recovered from previous cancer treatments and meet specific timelines for different therapies.
  • Must have a performance score of 50 or higher, indicating the ability to carry out daily activities.
  • Must have adequate organ function, including blood, liver, kidney, and heart health.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control.
  • Must agree to stop breastfeeding during the study.
  • Must provide written informed consent.

Exclusion Criteria

  • Under 1 year old.
  • Body surface area less than 0.25 m2.
  • Currently taking another investigational drug.
  • Currently receiving other cancer treatments.
  • Have an uncontrolled infection.
  • May not be able to comply with study requirements.
  • Had a severe allergic reaction to naxitimab in the past.

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