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Monoclonal Antibodies
Naxitamab for High-Risk Neuroblastoma
Phase 2
Recruiting
Research Sponsored by Giselle Sholler
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 7
Awards & highlights
Study Summary
This trial will study whether adding the drug naxitamab to standard induction therapy for high-risk neuroblastoma improves responses and survival.
Who is the study for?
This trial is for children and young adults up to 21 years old with newly diagnosed high-risk neuroblastoma. Participants must have certain types of the disease, good liver and kidney function, and not be pregnant or breastfeeding. They should agree to use effective contraception if applicable. Those who've had previous systemic therapy beyond one cycle or are on immunosuppressants may not qualify.Check my eligibility
What is being tested?
The study tests adding naxitamab to standard chemotherapy during the first five cycles of treatment for neuroblastoma. For patients with an ALK mutation, ceritinib will also be included once test results are available. The goal is to see if this combination improves response rates and survival compared to standard therapy alone.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion such as fever or chills, pain at tumor sites due to inflammation caused by immune response, changes in blood pressure, allergic reactions, bone marrow suppression leading to low blood cell counts which can increase infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 7
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 7
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with a Very Good Partial Response (VGPR)(+) rate (VGPR + Complete Response (CR) rate)
Secondary outcome measures
Number of days that subjects remain alive
Number of days that subjects remain in remission
Number of participants with treatment-related adverse events
+3 moreOther outcome measures
Morphine equivalent daily dose (MEDD) per subject
Side effects data
From 2023 Phase 3 trial • 231 Patients • NCT0182811270%
Diarrhoea
63%
Nausea
50%
Vomiting
43%
Alanine Aminotransferase Increased
42%
Decreased Appetite
37%
Aspartate Aminotransferase Increased
30%
Weight Decreased
27%
Fatigue
23%
Blood Alkaline Phosphatase Increased
23%
Gamma-Glutamyltransferase Increased
22%
Back Pain
22%
Asthenia
22%
Abdominal Pain
19%
Headache
19%
Constipation
19%
Blood Creatinine Increased
16%
Abdominal Pain Upper
15%
Pyrexia
14%
Cough
12%
Non-Cardiac Chest Pain
11%
Rash
11%
Electrocardiogram Qt Prolonged
11%
Dyspnoea
10%
Arthralgia
10%
Nasopharyngitis
10%
Musculoskeletal Pain
9%
Pruritus
9%
Dizziness
9%
Hypokalaemia
8%
Musculoskeletal Chest Pain
7%
Hyperglycaemia
7%
Insomnia
6%
Amylase Increased
6%
Neck Pain
5%
Dry Skin
5%
Alopecia
5%
Anaemia
5%
Malaise
5%
Pain In Extremity
4%
Pleural Effusion
4%
General Physical Health Deterioration
4%
Pneumonia
4%
Stomatitis
4%
Productive Cough
3%
Neutropenia
3%
Respiratory Failure
3%
Paraesthesia
3%
Oedema Peripheral
3%
Pericardial Effusion
3%
Myalgia
2%
Dehydration
2%
Leukopenia
2%
White Blood Cell Count Decreased
2%
Respiratory Tract Infection
2%
Epilepsy
2%
Atrial Fibrillation
2%
Muscular Weakness
1%
Pericarditis
1%
Visual Field Defect
1%
Neuropathy Peripheral
1%
Petit Mal Epilepsy
1%
Lower Respiratory Tract Infection
1%
Gastrointestinal Obstruction
1%
Gastrointestinal Perforation
1%
Lung Infiltration
1%
Cerebrovascular Accident
1%
Loss Of Consciousness
1%
Urinary Bladder Rupture
1%
Lenticular Opacities
1%
Dysphagia
1%
Electrocardiogram T Wave Inversion
1%
Faecaloma
1%
Jaundice
1%
Hyponatraemia
1%
Mobility Decreased
1%
Aphasia
1%
Biliary Tract Infection
1%
Brain Mass
1%
Typhoid Fever
1%
Surgery
1%
Neutrophil Count Decreased
1%
Chest Pain
1%
Cognitive Disorder
1%
Coordination Abnormal
1%
Depressed Level Of Consciousness
1%
Hypoxia
1%
Interstitial Lung Disease
1%
Respiratory Distress
1%
Deep Vein Thrombosis
1%
Seizure
1%
Atrial Flutter
1%
Myocardial Ischaemia
1%
Pathological Fracture
1%
Metastases To Central Nervous System
1%
Tumour Flare
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ceritinib
Chemotherapy
Trial Design
2Treatment groups
Experimental Treatment
Group I: Subjects with ALK aberrationExperimental Treatment2 Interventions
5 cycles of standard of care induction + naxitimab + ceritinib
Naxitimab on Days 1, 3, and 5 of each cycle Ceritinib once daily on every day of study
Group II: Subjects with ALK Wildtype or UnknownExperimental Treatment1 Intervention
5 cycles of standard of care induction + naxitimab
Naxitimab on Days 1, 3, and 5 of each cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceritinib
2013
Completed Phase 3
~1030
Find a Location
Who is running the clinical trial?
Giselle ShollerLead Sponsor
21 Previous Clinical Trials
2,129 Total Patients Enrolled
18 Trials studying Neuroblastoma
1,502 Patients Enrolled for Neuroblastoma
Y-mAbsUNKNOWN
Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,004,191 Total Patients Enrolled
19 Trials studying Neuroblastoma
1,572 Patients Enrolled for Neuroblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer was diagnosed at an advanced stage (INSS 2A/2B, 3, or 4).My heart and liver are functioning well.I was 21 years old or younger when first diagnosed.I have not had systemic therapy, except in specific cases.I am a woman who can have children and I have a negative pregnancy test.I am under 1 year old.I have been diagnosed with neuroblastoma or ganglioneuroblastoma.I have not had immunosuppressive treatment in the last 4 weeks.I am older than 12 months.I am not between 12-18 months old with specific advanced neuroblastoma stages.My lung function is not normal.I can undergo a procedure to collect stem cells from my blood.My kidney function is good for my age and gender.
Research Study Groups:
This trial has the following groups:- Group 1: Subjects with ALK Wildtype or Unknown
- Group 2: Subjects with ALK aberration
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients who are middle-aged eligible for this test?
"The lower age limit for this study is 12 months old and the maximum age a patient can be is 21."
Answered by AI
If I am eligible, may I sign up for this clinical trial?
"This trial is looking for 76 participants that currently have high-risk neuroblastoma and are between 12 months and 21 years old. In addition, patients must meet the following criteria: a) Subjects with newly diagnosed neuroblastoma with International Neuroblastoma Staging System (INSS) Stage 4 are eligible with the following: i. Age > 18 months (> 547 days) regardless of biologic features or ii. Age 12-18 months (365-547 days) with any of the following 3 unfavorable biologic features (MYCN amplification, unfavorable pathology and/or DNA index = 1) or iii. MYCN amplification (>"
Answered by AI
How many volunteers are helping to test this new medication?
"That is correct. The clinicaltrials.gov website has information indicating that this study, which was originally posted on 9/14/2022, is still looking for volunteers. They need a total of 76 people at 2 different locations."
Answered by AI
Are there any harmful side effects associated with Naxitamab?
"Naxitamab's safety was given a score of 2 by our analysts at Power. This is due to the lack of data regarding its efficacy, as this is only a Phase 2 trial."
Answered by AI
Are researchers still enrolling participants for this experiment?
"That is right, the clinicaltrials.gov website indicates that this trial is open for enrollment. The listing was created on 9/14/2022 and was last updated 9/20/2022. They are looking for 76 individuals total from 2 different hospitals or clinics."
Answered by AI
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