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Monoclonal Antibodies

Tipifarnib + Naxitamab for Neuroblastoma

Phase 2
Waitlist Available
Research Sponsored by Giselle Sholler
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have a Lansky or Karnofsky Performance Scale score of ≥ 50
All subjects must have a pathologically confirmed diagnosis of neuroblastoma at any point in their treatment
Must not have
Subjects who are less than 1 year of age
Subjects with an uncontrolled infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months plus 5 years follow up
Awards & highlights
No Placebo-Only Group

Summary

"This trial is testing a new drug called tipifarnib, taken as a pill, along with an FDA-approved drug called naxitimab, given through a tube into a vein. N

Who is the study for?
This trial is for patients with neuroblastoma that has come back or hasn't responded to treatment. Participants must have had some response or stable disease after previous therapy and be suitable for taking tipifarnib orally and receiving naxitamab intravenously.
What is being tested?
The study tests the safety and effectiveness of combining tipifarnib, a pill, with naxitamab, an IV drug approved by the FDA for certain cases of neuroblastoma. The goal is to see how well patients respond to this combination and how long they live without their cancer worsening.
What are the potential side effects?
Possible side effects include reactions related to the infusion process, issues from the drugs affecting organs, fatigue, nausea, blood-related problems, and increased risk of infections. Each patient's experience may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can do most activities but may need help.
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My diagnosis of neuroblastoma has been confirmed by a pathology report.
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My neuroblastoma has returned or didn't respond to treatment, and it can be measured or seen.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 1 year old.
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I do not have any infections that aren't responding to treatment.
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I had a severe allergic reaction to naxitamab and stopped treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months plus 5 years follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months plus 5 years follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine the Overall Response Rate (ORR) of Participants using INSS Response
Secondary study objectives
Length of time that participants experience Overall Survival (OS)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Number of participants with progression free survival (PFS) during study

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: HRNB Bone/Bone MarrowExperimental Treatment2 Interventions
Cycles 1-6: Tipifarnib and Naxitamab Tipifarnib: on days 1-7 and 15-21 of each 28-day cycle. Naxitamab IV on Days 1, 3, and 5 of each cycle.
Group II: HRNB All othersExperimental Treatment2 Interventions
Cycles 1-6: Tipifarnib and Naxitamab Tipifarnib: on days 1-7 and 15-21 of each 28-day cycle. Naxitamab IV on Days 1, 3, and 5 of each cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tipifarnib
2019
Completed Phase 3
~1000

Find a Location

Who is running the clinical trial?

Giselle ShollerLead Sponsor
22 Previous Clinical Trials
2,392 Total Patients Enrolled
19 Trials studying Neuroblastoma
1,765 Patients Enrolled for Neuroblastoma
Giselle SaulnierSholler, MDStudy ChairBeat Childhood Cancer
~65 spots leftby Aug 2030
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