Evolutionary Therapy for Rhabdomyosarcoma

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.

Conditions

Rhabdomyosarcoma

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Study Overview

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Study Details

Study overview

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.

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

Evolutionary Therapy for Rhabdomyosarcoma

Condition
Rhabdomyosarcoma
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States, 35294

Aurora

Children's Hospital of Colorado, Aurora, Colorado, United States, 80045

Hartford

Connecticut Children's Medical Center, Hartford, Connecticut, United States, 06106

Gainesville

University of Florida, Gainesville, Florida, United States, 32610

Miami

University of Miami - Sylvester Comprehensive Cancer Center, Miami, Florida, United States, 33136

Saint Petersburg

Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States, 33701

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 33612

Bronx

Montefiore Medical Cancer Center, Bronx, New York, United States, 10467

Buffalo

Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States, 14263

Chapel Hill

University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States, 27599

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

H. Lee Moffitt Cancer Center and Research Institute,

Jonathan Metts, MD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

2027-08