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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

Must not have

Severe dysfunction of major organs, i.e., renal, cardiac, hepatic, neurologic, pulmonary, hematologic, or gastrointestinal toxicity ≥ grade 3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I have had only one round of chemotherapy.

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I am under 19 years old.

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My neuroblastoma is high-risk and either has MYCN amplification or is stage 4 and I'm over 18 months old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe problems with my kidneys, heart, liver, brain, lungs, blood, or stomach.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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%

Tachycardia

31%

Diarrhoea

31%

Hypokalaemia

27%

Constipation

27%

Hypophosphataemia

27%

Back pain

23%

Dizziness

23%

Tremor

23%

B-cell lymphoma

23%

Platelet count decreased

23%

White blood cell count decreased

19%

Cough

19%

Agitation

19%

Hyponatraemia

19%

Neutropenia

19%

Tachypnoea

19%

Hypogammaglobulinaemia

19%

Oedema peripheral

15%

Hypomagnesaemia

15%

Thrombocytopenia

15%

Dysphagia

15%

Alanine aminotransferase increased

15%

Sinus tachycardia

15%

Chills

15%

Dyspnoea

12%

Aspartate aminotransferase increased

12%

Pain

12%

Arthralgia

12%

Myalgia

12%

Hypertension

12%

Hyperglycaemia

12%

Hypoxia

12%

Vomiting

12%

Abdominal pain

12%

Peripheral sensory neuropathy

12%

Covid-19

12%

Malaise

Dysuria

Muscular weakness

Blood creatinine increased

Hyperhidrosis

Insomnia

Acute myeloid leukaemia

Encephalopathy

Sepsis

Pancytopenia

Eye pain

Lymphocyte count decreased

Asthenia

Urinary tract infection

Somnolence

Oral candidiasis

Pneumonia

Gait disturbance

Aphasia

Pleural effusion

Depression

Embolism

Syncope

Respiratory failure

Febrile neutropenia

Covid-19 pneumonia

100%

80%

60%

40%

20%

Study treatment Arm

Axicabtagene Ciloleucel and Rituximab Combination

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Vincristine

2003

Completed Phase 4

~2970

Mesna

2003

Completed Phase 2

~1380