ACTIVE_NOT_RECRUITING

Evolutionary Therapy for Rhabdomyosarcoma

Conditions

Rhabdomyosarcoma Soft Tissue Cancer Skeletal Muscle Tissue Cancer Sarcoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This clinical trial will evaluate 4 different strategies of chemotherapy schedules in newly diagnosed participants with metastatic Fusion Positive (alveolar) Rhabdomyosarcoma. The participant and their physician will choose from: Arm A) a first strike therapy, Arm B) a first strike-second strike (maintenance) therapy, Arm C) an adaptively timed therapy, and Arm D) conventional chemotherapy.

Official Title

Evolutionary Inspired Therapy for Newly Diagnosed, Metastatic, Fusion Positive Rhabdomyosarcoma

Quick Facts

Study Start:2020-12-29

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04388839

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Principal Investigator

Jonathan Metts, MD

PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Study Locations (Sites)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294

United States

Children's Hospital of Colorado

Aurora, Colorado, 80045

United States

Connecticut Children's Medical Center

Hartford, Connecticut, 06106

United States

University of Florida

Gainesville, Florida, 32610

United States

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, 33136

United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701

United States

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263

United States

Montefiore Medical Cancer Center

The Bronx, New York, 10467

United States

University of North Carolina Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

United States

Carolinas Medical Center, Levine Cancer Institute

Charlotte, North Carolina, 28204

United States

Duke Children's Hospital

Durham, North Carolina, 27710

United States

Cleveland Clinic

Cleveland, Ohio, 44106

United States

Nationwide Children's Hospital

Columbus, Ohio, 43205

United States

Vanderbilt - Ingram Cancer Center

Nashville, Tennessee, 37232

United States

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

United States

MD Anderson

Houston, Texas, 77030

United States

Primary Children's Medical Center/Utah

Salt Lake City, Utah, 84113

United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Jonathan Metts, MD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-29

Study Completion Date2027-08

Study Record Updates

Study Start Date2020-12-29

Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

Soft Tissue Cancer
Skeletal Muscle Tissue Cancer
Sarcoma

Additional Relevant MeSH Terms

Rhabdomyosarcoma