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Alkylating agents

Combination Chemotherapy for Neuroblastoma

Phase < 1
Recruiting
Led By Brian Kushner, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No more than one prior cycle of chemotherapy
Age <19 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Study Summary

This trial is testing a combination of 3 different chemo drugs to treat neuroblastoma in children. The goal is to see if it is safe and effective.

Who is the study for?
This trial is for children aged 1 to less than 13 with neuroblastoma, who have had no more than one prior chemo treatment. They must have a certain level of heart function and kidney function, as well as adequate liver function. Children with severe organ dysfunction or inability to follow the study plan cannot participate.Check my eligibility
What is being tested?
The N9 study tests three combinations of chemotherapy drugs (CTV, ICE, CDV) in cycles to determine their safety and effectiveness against pediatric neuroblastoma. Each drug combo includes agents like Cyclophosphamide and Doxorubicin known for treating cancer.See study design
What are the potential side effects?
Chemotherapy drugs used in this trial can cause side effects such as nausea, vomiting, hair loss, increased risk of infection due to low blood cell counts, mouth sores, diarrhea or constipation. Heart and kidney functions are monitored because these organs can be affected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had only one round of chemotherapy.
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I am under 19 years old.
Select...
My neuroblastoma is high-risk and either has MYCN amplification or is stage 4 and I'm over 18 months old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess safety of the N9 regimen in participants with HR-NB through toxicity assessment

Side effects data

From 2023 Phase 2 trial • 27 Patients • NCT04002401
88%
Pyrexia
65%
Neutrophil count decreased
62%
Nausea
58%
Hypotension
50%
Anaemia
46%
Headache
38%
Fatigue
38%
Decreased appetite
35%
Confusional state
31%
Diarrhoea
31%
Hypokalaemia
31%
Tachycardia
27%
Back pain
27%
Constipation
27%
Hypophosphataemia
23%
Tremor
23%
White blood cell count decreased
23%
B-cell lymphoma
23%
Platelet count decreased
23%
Dizziness
19%
Agitation
19%
Neutropenia
19%
Hypogammaglobulinaemia
19%
Tachypnoea
19%
Oedema peripheral
19%
Cough
19%
Hyponatraemia
15%
Hypomagnesaemia
15%
Dysphagia
15%
Dyspnoea
15%
Chills
15%
Thrombocytopenia
15%
Alanine aminotransferase increased
15%
Sinus tachycardia
12%
Aspartate aminotransferase increased
12%
Hypoxia
12%
Malaise
12%
Abdominal pain
12%
Pain
12%
Hypertension
12%
Arthralgia
12%
Peripheral sensory neuropathy
12%
Myalgia
12%
Vomiting
12%
Covid-19
12%
Hyperglycaemia
8%
Aphasia
8%
Dysuria
8%
Lymphocyte count decreased
8%
Sepsis
8%
Muscular weakness
8%
Pneumonia
8%
Oral candidiasis
8%
Blood creatinine increased
8%
Urinary tract infection
8%
Pancytopenia
8%
Hyperhidrosis
8%
Eye pain
8%
Somnolence
8%
Encephalopathy
8%
Gait disturbance
8%
Acute myeloid leukaemia
8%
Asthenia
8%
Insomnia
4%
Respiratory failure
4%
Syncope
4%
Covid-19 pneumonia
4%
Embolism
4%
Depression
4%
Pleural effusion
4%
Febrile neutropenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel and Rituximab Combination

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with newly-diagnosed HR-NeuroblastomaExperimental Treatment8 Interventions
This pilot study of N9 as induction chemotherapy will enroll 30 patients with newly-diagnosed HR-NB. A first cohort of >1 to 12-year old, and a second cohort of extended age <19 years old. Both cohorts will be analyzed together.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Carboplatin
2014
Completed Phase 3
~6670
Doxorubicin
2012
Completed Phase 3
~7940
Vincristine
2003
Completed Phase 4
~2910
Ifosfamide
2010
Completed Phase 4
~2980
Etoposide
2010
Completed Phase 3
~2440
Mesna
2003
Completed Phase 2
~1380
Topotecan
2017
Completed Phase 3
~2400

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,930 Previous Clinical Trials
597,348 Total Patients Enrolled
49 Trials studying Neuroblastoma
5,761 Patients Enrolled for Neuroblastoma
Brian Kushner, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
10 Previous Clinical Trials
1,107 Total Patients Enrolled
10 Trials studying Neuroblastoma
1,107 Patients Enrolled for Neuroblastoma

Media Library

Neuroblastoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04947501 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any availabilities for participants in this research project?

"This medical research is still recruiting patients, as indicated by clinicaltrials.gov records that show the trial was first posted on June 22nd 2021 and updated most recently on August 11th 2022."

Answered by AI

Is this trial accessible to those of advanced age?

"The eligibility requirements for this trial stipulate that qualified candidates be between 1 and 13 years old. On clinicaltrials.gov, 595 trials are available to minors, while 1447 studies accept geriatric patients."

Answered by AI

Has this medical trial been previously attempted?

"Since its initial trial, sponsored by Alfacell in 1997 and involving 300 patients, Cyclophosphamide has been subject to considerable research. This culminated in the Phase 3 drug approval for this medication. Currently, 1675 trials are underway across 83 countries with 3640 sites participating."

Answered by AI

What maladies has Cyclophosphamide demonstrated efficacy in treating?

"Cyclophosphamide is primarily used to address the symptoms of Kaposi's Sarcoma in those affected by HIV. It has also been observed to provide relief from Merkel cell cancer, leukemia, and other initial treatments."

Answered by AI

What precedent has been set for Cyclophosphamide research?

"Presently, there are 1675 on-going Cyclophosphamide clinical trials with 406 in their third phase of research. While many studies for this drug occur near Bethesda, Maryland, they also take place at over 76k sites worldwide."

Answered by AI

How many participants have been enrolled in this clinical experiment?

"Yes, the information hosted on clinicaltrials.gov verifies that this medical trial is currently recruiting for participants. The study was initially posted on June 22nd 2021 and recently modified on August 11th 2022, with a total of 15 patients being sought after by one location."

Answered by AI

Would I be eligible to join this research project?

"This medical trial is actively recruiting 15 participants between the ages of 1 and 13 who have been clinically diagnosed with neuroblastoma. In addition to meeting this criteria, candidates must also abide by creatinine threshold values based on their age that were derived from a Schwartz formula outlined in Centers for Disease Control data. Furthermore, potential recruits will need to provide consent acknowledging they are aware of the experimental nature of treatment, no more than one cycle of chemotherapy has already been administered, shortening fraction must be ≥ 27% or ejection fraction needs to exceed 50%, total bilirubin levels should not surpass 1.5x normal upper limit for age"

Answered by AI
~9 spots leftby Jun 2025