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Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma

This study is testing a combination of two medicines, tipifarnib and naxitamab, for children and young adults with neuroblastoma that has come back or not responded to previous treatments. Tipifarnib is a pill you take by mouth, and naxitamab is given through a vein (IV). Naxitamab is already approved by the FDA for some neuroblastoma patients. This study aims to see how many participants respond to this treatment combination within 6 months. You may be able to join if you are between 1 and 21 years old and have a confirmed diagnosis of neuroblastoma. The study is currently unclear about its recruitment status and plans to enroll 98 participants.

Study design
This study is an interventional study, meaning participants will receive specific treatments. It plans to enroll 98 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at 6 months, which suggests follow-up for at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06540963

Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma

Recruiting
PHASE2Ages 1–21InterventionalTreatment
Giselle Sholler
~98 participants
Updated 2026-04-28 on ClinicalTrials.gov
What's tested:TipifarnibNaxitamab

At a glance

Recruiting sites
12 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the Overall Response Rate (ORR) of Participants using INSS Response
Measured over 6 months

Conditions

Neuroblastoma

Explore related trials

NeuroblastomaMYCN Gene

Where it's being run

12 sites across 10 states
Florida2
Texas2
Arkansas1
Connecticut1
Hawaii1
Missouri1
North Carolina1
Oregon1

Study leadership

  • Valerie Brown, MD, PhD · STUDY_CHAIR · Beat Childhood Cancer

Who to contact

BCC Enroll
[email protected]
7175310003
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Allogeneic: No evidence of active graft vs. host disease
Allo/Auto: ≥ 2 months must have elapsed since transplant. 7. MIBG Therapy: At least 6 weeks since treatment with MIBG therapy. 8. Subjects must have a Lansky or Karnofsky Performance Scale score of ≥ 50 9. Subjects must have adequate organ function at the time of enrollment:

What this trial measures

  • Determine the Overall Response Rate (ORR) of Participants using INSS Response6 months

    To evaluate the activity of Tipifarnib in combination with Naxitamab based on Overall response rate (ORR)