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Monoclonal Antibodies

HRNB All others 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 be age ≤ 21 years at initial diagnosis. Subjects must be \>12 months of age at enrollment. Safety Run-In (first 6 subjects) must be age 6 years or older.
2. Pathology: All subjects must have a pathologically confirmed diagnosis of neuroblastoma at any point in their treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months plus 5 years follow up
Awards & highlights

Summary

The purpose of this study is to evaluate the investigational drug, tipifarnib (a pill taken by mouth), in combination with the Food and Drug Administration (FDA) approved drug, naxitimab, administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins). Naxitamab is FDA approved for pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy, it may not be approved in the type of disease used in this study. The goals of this part of the study are: * Test the safety and tolerability of tipifarnib in combination with naxitimab in patients with cancer * To determine the activity of study treatments chosen based on: * How each subject responds to the study treatment * How long a subject lives without their disease returning/progressing

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

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

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
2,209 Total Patients Enrolled
19 Trials studying Neuroblastoma
1,582 Patients Enrolled for Neuroblastoma
Giselle SaulnierSholler, MDStudy ChairBeat Childhood Cancer
~65 spots leftby Aug 2030