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Can a Tumor's own cells reveal the best drug for each child?

NCT ID NCT05857969

Disease control Sponsor: Florida International University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This trial explores whether testing a child's own tumor cells against a panel of approved drugs can help doctors choose a personalized treatment plan. It enrolls children and young adults up to age 21 with recurrent or refractory cancers, including leukemias, lymphomas, and solid tumors. Tumor samples from routine biopsies are analyzed for drug sensitivity and genetic changes, with the goal of recommending a tailored therapy within four weeks. The study aims to see if this functional precision medicine approach is feasible and whether it can improve outcomes compared to standard care.

What this could mean

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

Active substance
Functional precision medicine, combining ex vivo drug sensitivity testing and genomic tumor profiling to select individualized therapies
What this could lead to
If successful, this approach could help doctors choose more effective, personalized treatments for children with hard-to-treat cancers, potentially improving outcomes.
What could go wrong
This is an early-phase feasibility study, so it may not lead to better outcomes for all patients. Tumor testing might not always yield actionable results within the 4-week window, and the approach may not work for every cancer type.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 65 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Dec 2028

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 day to 21 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: * Patients aged 21 years or younger at the time of enrollment on this study of any gender, race or ethnicity. Subjects with suspected or confirmed diagnosis of recurrent or refractory cancer Subjects who are scheduled for or have recently had biopsy or tumor excised (solid tumors) or bone marrow aspirate (blood cancers) Subjects willing to have a blood draw or buccal swab done for the purposes of genetic testing Subjects or their parents or legal guardians willing to sign informed consent Subjects aged 7 to 17 willing to sign assent Exclusion Criteria: * Subjects who do not have malignant tissue available and accessible The amount of excised malignant tissue is not sufficient for the ex vivo drug testing and/or genetic profiling. Patients with newly diagnosed tumors and tumors that have high (\>90%) cure rate with safe standard therapy.

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Conditions

The condition(s) this trial relates to.

childhood acute myeloid leukemia childhood ependymoma interdigitating dendritic cell sarcoma Leukemia, Myelogenous, Chronic, BCR-ABL Positive neoplasm Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

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

Recurrent childhood acute lymphoblastic leukemia Recurrent childhood acute myeloid leukemia Recurrent childhood brain tumor Recurrent childhood brainstem glioma Recurrent childhood ependymoma Recurrent childhood gliosarcoma Recurrent childhood large cell lymphoma Recurrent childhood lymphoblastic lymphoma Recurrent childhood malignant neoplasm Recurrent childhood malignant solid neoplasm Recurrent childhood rhabdomyosarcoma Recurrent childhood soft tissue sarcoma Refractory childhood acute lymphoblastic leukemia Refractory childhood Hodgkin lymphoma Refractory childhood malignant germ cell neoplasm Refractory childhood malignant neoplasm Refractory childhood malignant solid neoplasm Refractory chronic myelogenous leukemia, BCR-ABL1 positive

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Nicklaus Children's Hospital

    RECRUITING

    Miami, Florida, 33155, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

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