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New vaccine combo aims to outsmart relapsed neuroblastoma in kids

NCT ID NCT01192555

Disease control Sponsor: Baylor College of Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a tumor vaccine combined with daily low-dose chemotherapy for children whose high-risk neuroblastoma has returned or not responded to standard treatment. The vaccine is designed to train the immune system to recognize and attack neuroblastoma cells, while the low-dose chemo helps block tumor blood vessels and reduce cells that hide the tumor from the immune system. The main goals are to check safety and see if the treatment can slow or stop the cancer.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

11 people

The number who actually took part.

Start date

Sep 2010

Expected to finish

Sep 2026

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Histologically proven high risk neuroblastoma in first or subsequent relapse or with primary refractory disease or inability to complete standard therapy * Age less than 21 at time of initial diagnosis * Life expectancy 12 weeks or greater * Karnofsky or Lansky score of 50 or greater * Platelet count of 50,000/ul or greater * ANC greater than 750/ul * Alk Phos level less than 2.5 x upper limit of normal * Bilirubin less than 2x normal * AST less than 3x normal * Hgb 8.0 or greater * Creatinine 2 x ULN or less OR GFR greater than 40 ml/min/1.73 m2 * Patient has recovered from last chemotherapy or investigational therapy prior to study enrollment * Women of child-bearing potential must not be pregnant and take/use effective birth control while participating in the study. EXCLUSION CRITERIA: * Due to the unknown effects of this therapy on a fetus, pregnant women will be excluded from this research * Women who are breast-feeding * Known HIV positive subjects since treatment may be immunosuppressive * Severe intercurrent infection or uncontrolled condition including, but not limited to ongoing or active infection, symptomatic heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Previous use of oral cytoxan for more than 2 consecutive months within the last 6 months * Patients currently receiving any investigational agents or have received any tumor vaccines within the previous six months * Patients, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

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Conditions

The condition(s) this trial relates to.

neuroblastoma

As listed by the trial registrant

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

Neuroblastoma

Contacts and locations

Locations

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

More trials for these conditions

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