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Can a shorter chemo combo tame High-Risk neuroblastoma?

NCT ID NCT04947501

Disease control Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This pilot study is testing a new, shortened chemotherapy regimen called N9 for children with high-risk neuroblastoma, a type of cancer. The regimen combines several chemotherapy drugs given in different cycles to see if it is safe and effective. The study includes children under 19 years old with high-risk neuroblastoma who have had no more than one prior cycle of chemotherapy. The goal is to assess the safety and potential effectiveness of this approach.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A combination of chemotherapy drugs: cyclophosphamide, topotecan, vincristine, ifosfamide, carboplatin, etoposide, and doxorubicin
What this could lead to
If successful, this shortened chemotherapy approach could become a safer and more effective way to treat high-risk neuroblastoma in children, potentially improving outcomes.
What could go wrong
This is an early-phase pilot study with a small number of participants, so results may not be conclusive. Chemotherapy carries risks of side effects, and the regimen may not prove more effective than standard treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

26 people

The number who actually took part.

Started

Jun 2021

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 19 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of NB as defined by histopathology (confirmed by the MSK Department of Pathology), BM metastases plus high urine catecholamine levels, or positivity in MIBG scan. * HR-NB, defined as MYCN-amplified stage 2/3/4/4S at any age and stage 4 in patients \>18 months old. * No more than one prior cycle of chemotherapy. * Age \<19 years old. * Signed informed consent indicating awareness of the investigational nature of this treatment. Exclusion Criteria: * Severe dysfunction of major organs, i.e., renal, cardiac, hepatic, neurologic, pulmonary, hematologic, or gastrointestinal toxicity ≥ grade 3. * Inability to comply with protocol requirements. * Pregnancy is not an issue because all patients will be pre-adolescents.

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Conditions

The condition(s) this trial relates to.

childhood malignant neoplasm neoplasm neuroblastoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neuroblastoma Pediatric cancer

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.