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New chemo timing strategies aim to outsmart aggressive childhood cancer

NCT ID NCT04388839

Disease control Sponsor: H. Lee Moffitt Cancer Center and Research Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 four different chemotherapy schedules in children and adults with a rare, aggressive muscle cancer that has spread. Participants choose from a first-strike approach, a first-strike followed by maintenance, an adaptive schedule, or standard chemo. The goal is to see which timing works best to delay cancer return and improve survival.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

12 people

The number who actually took part.

Started

Dec 2020

Expected to finish

Aug 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

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: * Participants must have a new histologic diagnosis of rhabdomyosarcoma * Participants must have FISH, PCR or other molecular confirmation of PAX/FOXO1 fusion per institutional standards * Participants must have sufficient tissue (up to 10 unstained FFPE) for correlative testing * All participants must have distant metastatic disease; either biopsy positive or PET avid extranodal or distant nodal lesions determined by the investigator to be metastatic disease. Patients with a single distant metastatic site that has been excised prior to study entry are eligible * No prior systemic chemotherapy * Participants enrolled to Arm B, maintenance, must be able to take oral cyclophosphamide. Note: enteral administration of cyclophosphamide is allowable. * Males and females of reproductive potential may not participate unless they have agreed to the use of, at minimum, two methods of contraception during and after treatment or abstinence. * Women of childbearing potential should adhere to contraception for a period of 4 months after completion of systematic chemotherapy administration * Men who are sexually active with women of child bearing potential should adhere to contraception for a period of 4 months after completion of systematic chemotherapy administration * All patients and/or their parents or legal guardians must have the ability to understand and the willingness to sign a written informed consent or assent document. Exclusion Criteria: * Participants with regional lymph nodes as the only site of disease are not eligible. Distant nodal sites alone are eligible * Participants who are receiving any other investigational agents for rhabdomyosarcoma are ineligible * Participants must not be receiving any additional medicines being given for the specific purpose of treating cancer. Alternative medications including, but not limited to cannabis based products would not be a reason for exclusion * Participants are ineligible if they have uncontrolled intercurrent illness including, but not limited to: * ongoing or active infection not expected to resolve with current antibiotic plan * cardiac arrhythmia * psychiatric illness/social situations that would limit compliance with study requirements * Patients who are pregnant or breastfeeding are not eligible because there is no available information regarding human fetal or teratogenic toxicities. Females of childbearing potential must have a negative serum or urine pregnancy test within 24 hours of starting protocol therapy. * Participants who are considered unable to comply with the safety monitoring requirements of the study are not eligible

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Conditions

The condition(s) this trial relates to.

alveolar rhabdomyosarcoma rhabdomyosarcoma sarcoma

As listed by the trial registrant

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

Rhabdomyosarcoma

Contacts and locations

Locations

  • Carolinas Medical Center, Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Children's Hospital of Colorado

    Aurora, Colorado, 80045, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44106, United States

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106, United States

  • Duke Children's Hospital

    Durham, North Carolina, 27710, United States

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701, United States

  • MD Anderson

    Houston, Texas, 77030, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Montefiore Medical Cancer Center

    The Bronx, New York, 10467, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Primary Children's Medical Center/Utah

    Salt Lake City, Utah, 84113, United States

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263, United States

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294, United States

  • University of Florida

    Gainesville, Florida, 32610, United States

  • University of Miami - Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136, United States

  • University of North Carolina Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Vanderbilt - Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

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