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Can a new chemo combo help kids whose solid tumors came back?

NCT ID NCT02013336

Disease control Sponsor: South Plains Oncology Consortium 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 08, 2026 · Last updated Oct 09, 2026 · Updated 1 time

Summary

Researchers are testing a combination of two chemotherapy drugs, MM-398 and cyclophosphamide, in children and young adults with solid tumors that have returned or stopped responding to treatment. The trial includes patients with Ewing sarcoma, rhabdomyosarcoma, neuroblastoma, or osteosarcoma. The main goal is to find the highest dose of MM-398 that can be given safely alongside cyclophosphamide.

What this could mean

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

Active substance
MM-398 (irinotecan sucrosofate liposome injection) plus cyclophosphamide
What this could lead to
If the combination proves safe, it could offer a new treatment option for children with solid tumors that have come back or stopped responding to other therapies.
What could go wrong
This is an early-stage trial with a small number of participants, so it may not find a safe dose or show benefit. Combining two chemotherapy drugs can cause serious side effects.

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 30 people

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

Started

Dec 2013

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Ages

12 months to 20 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: * Histologically or cytologically-confirmed Ewing sarcoma, rhabdomyosarcoma, neuroblastoma, or osteosarcoma * Disease progression after prior therapy in locally advanced or metastatic setting * Measurable or evaluable disease based on the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria * Age 12 months to \<21 years * Adequate bone marrow reserves, hepatic function, and renal function * Recovered from effects of any prior surgery or cancer therapy * Patients 18 years or older will provide written consent. A parent or legal guardian of a patient \<18 years of age will provide informed consent and patients 11 to 18 years of age will provide written assent or as per participating institutional policy. Exclusion Criteria: * Clinically significant gastrointestinal disorders * NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure * Active infection or unexplained fever * Known hypersensitivity to any of the components of MM-398 or other liposomal products * Recent Investigational therapy * Pregnant or breast feeding; females of child-bearing potential must test negative for pregnancy at the time of enrollment

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Conditions

The condition(s) this trial relates to.

Ewing sarcoma neuroblastoma osteosarcoma Recurrence rhabdomyosarcoma

As listed by the trial registrant

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

Ewing sarcoma Neuroblastoma Osteosarcoma Recurrent or refractory solid tumors Rhabdomyosarcoma

How to take part

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

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Midwest Children's Hospital

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Texas Tech University Health Sciences Center

    RECRUITING

    Lubbock, Texas, 79430, United States

  • UT Southwestern

    RECRUITING

    Dallas, Texas, 75235, United States

  • University Of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

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