RECRUITING

Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma

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

Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.

Official Title

A Prospective Phase 3 Study of Patients With Newly Diagnosed Very Low-Risk and Low-Risk Fusion Negative Rhabdomyosarcoma

Quick Facts

Study Start:2022-08-04
Study Completion:2030-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05304585

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 to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * All patients must be enrolled on APEC14B1 (NCT02402244) and consented to the Molecular Characterization Initiative (Part A) prior to enrollment and treatment on ARST2032 (this trial).
  2. * Patients must be =\< 21 years at the time of enrollment.
  3. * Patients must have newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell/sclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma (ARMS) (institutional FOXO1 fusion results are acceptable). RMS types included under ERMS include those classified in the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the 2020 World Health Organization (WHO) classification as ERMS (classic, dense and botryoid variants) and spindle cell/sclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant). Enrollment in APEC14B1 is required for all patients.
  4. * All patients will be evaluated for stage and clinical group. Note that clinical group designation assigned at the time of enrollment on study remains unchanged regardless of any second-look operation that may be performed.
  5. * Patients will be eligible for the very low-risk stratum (Regimen VA) if they have Stage 1, CG I disease.
  6. * Patients will be eligible for the low-risk stratum (Regimen VAC/VA) if they have Stage 1, CG II disease, Stage 2, CG I or II disease, or Stage 1, CG III (orbit only) disease.
  7. * Paratesticular Tumors: Staging ipsilateral retroperitoneal lymph node sampling (SIRLNS) is required for all patients \>= 10 years of age with paratesticular tumors who do not have gross nodal involvement on imaging.
  8. * Extremity Tumors: Regional lymph node sampling is required for histologic evaluation in patients with extremity tumors.
  9. * Clinically or radiographically enlarged nodes must be sampled for histologic evaluation.
  10. * Patients must have a Lansky (for patients =\< 16 years of age) or Karnofsky (for patients \> 16 years of age) performance status score of \>= 50. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing performance score.
  11. * Peripheral absolute neutrophil count (ANC) \>= 750/uL (within 7 days prior to enrollment).
  12. * Platelet count \>= 75,000/uL (transfusion independent) (within 7 days prior to enrollment).
  13. * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or a serum creatinine (within 7 days prior to enrollment) based on age/gender as follows:
  14. * Age: 1 month to \< 6 months; Maximum serum creatinine (mg/dL): 0.4 (male) : 0.4 (female)
  15. * Age: 6 months to \< 1 year; Maximum serum creatinine (mg/dL): 0.5 (male) : 0.5 (female)
  16. * Age: 1 to \< 2 years; Maximum serum creatinine (mg/dL): 0.6 (male) : 0.6 (female)
  17. * Age: 2 to \< 6 years; Maximum serum creatinine (mg/dL): 0.8 (male) : 0.8 (female)
  18. * Age: 6 to \< 10 years; Maximum serum creatinine (mg/dL): 1 (male) : 1 (female)
  19. * Age: 10 to \< 13 years; Maximum serum creatinine (mg/dL): 1.2 (male) : 1.2 (female)
  20. * Age: 13 to \< 16 years; Maximum serum creatinine (mg/dL): 1.5 (male) : 1.4 (female)
  21. * Age \>= 16 years; Maximum serum creatinine (mg/dL): 1.7 (male) : 1.4 (female)
  22. * Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment), and
  23. * If there is evidence of biliary obstruction by the tumor, then the total bilirubin must be \< 3 x ULN for age.
  24. * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L.
  25. * Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L
  26. * If there is evidence of biliary obstruction by the tumor, then the total bilirubin must be \< 3 x ULN for age
  27. * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
  28. * All patients and/or their parents or legal guardians must sign a written informed consent.
  29. * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
  1. * Patients who have received prior chemotherapy and/or radiation therapy for cancer prior to enrollment. Surgical resection alone of previous cancer(s) is permitted.
  2. * Patients who have received chemotherapy or radiation for non-malignant conditions (e.g., autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy.
  3. * Vincristine is sensitive substrate of the CYP450 3A4 isozyme. Patients must not have received drugs that are moderate to strong CYP3A4 inhibitors and inducers within 7 days prior to study enrollment.
  4. * Patients unable to undergo radiation therapy, if necessary, as specified in the protocol.
  5. * Evidence of uncontrolled infection.
  6. * Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
  7. * Lactating females who plan to breastfeed their infants.
  8. * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.

Contacts and Locations

Principal Investigator

Josephine H Haduong
PRINCIPAL_INVESTIGATOR
Children's Oncology Group

Study Locations (Sites)

Children's Hospital of Alabama
Birmingham, Alabama, 35233
United States
USA Health Strada Patient Care Center
Mobile, Alabama, 36604
United States
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
United States
Kaiser Permanente Downey Medical Center
Downey, California, 90242
United States
Loma Linda University Medical Center
Loma Linda, California, 92354
United States
Miller Children's and Women's Hospital Long Beach
Long Beach, California, 90806
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
Mattel Children's Hospital UCLA
Los Angeles, California, 90095
United States
Valley Children's Hospital
Madera, California, 93636
United States
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
United States
Kaiser Permanente-Oakland
Oakland, California, 94611
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304
United States
Rady Children's Hospital - San Diego
San Diego, California, 92123
United States
Naval Medical Center -San Diego
San Diego, California, 92134
United States
UCSF Medical Center-Mission Bay
San Francisco, California, 94158
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, 80218
United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
United States
Yale University
New Haven, Connecticut, 06520
United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
United States
Children's National Medical Center
Washington, District of Columbia, 20010
United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610
United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
United States
Nicklaus Children's Hospital
Miami, Florida, 33155
United States
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
United States
Nemours Children's Hospital
Orlando, Florida, 32827
United States
Sacred Heart Hospital
Pensacola, Florida, 32504
United States
Johns Hopkins All Children's Hospital
Saint Petersburg, Florida, 33701
United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607
United States
Saint Mary's Hospital
West Palm Beach, Florida, 33407
United States
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, 30329
United States
Memorial Health University Medical Center
Savannah, Georgia, 31404
United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
United States
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611
United States
University of Illinois
Chicago, Illinois, 60612
United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, 60453
United States
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois, 60068
United States
Saint Jude Midwest Affiliate
Peoria, Illinois, 61637
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
United States
Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, 60190
United States
Riley Hospital for Children
Indianapolis, Indiana, 46202
United States
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana, 46260
United States
Blank Children's Hospital
Des Moines, Iowa, 50309
United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
United States
Norton Children's Hospital
Louisville, Kentucky, 40202
United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
United States
Maine Children's Cancer Program
Scarborough, Maine, 04074
United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
United States
Corewell Health Children's
Royal Oak, Michigan, 48073
United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
United States
Cardinal Glennon Children's Medical Center
Saint Louis, Missouri, 63104
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
United States
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
United States
Renown Regional Medical Center
Reno, Nevada, 89502
United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
United States
Albany Medical Center
Albany, New York, 12208
United States
Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
University of Rochester
Rochester, New York, 14642
United States
State University of New York Upstate Medical University
Syracuse, New York, 13210
United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
East Carolina University
Greenville, North Carolina, 27834
United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Dayton Children's Hospital
Dayton, Ohio, 45404
United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
United States
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605
United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
United States
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916
United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203
United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
United States
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
United States
Medical City Dallas Hospital
Dallas, Texas, 75230
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
United States
El Paso Children's Hospital
El Paso, Texas, 79905
United States
Cook Children's Medical Center
Fort Worth, Texas, 76104
United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
United States
M D Anderson Cancer Center
Houston, Texas, 77030
United States
Covenant Children's Hospital
Lubbock, Texas, 79410
United States
UMC Cancer Center / UMC Health System
Lubbock, Texas, 79415
United States
Children's Hospital of San Antonio
San Antonio, Texas, 78207
United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
United States
Scott and White Memorial Hospital
Temple, Texas, 76508
United States
Primary Children's Hospital
Salt Lake City, Utah, 84113
United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042
United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
United States
Carilion Children's
Roanoke, Virginia, 24014
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
United States
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405
United States
Madigan Army Medical Center
Tacoma, Washington, 98431
United States
West Virginia University Charleston Division
Charleston, West Virginia, 25304
United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
United States

Collaborators and Investigators

Sponsor: Children's Oncology Group

  • Josephine H Haduong, PRINCIPAL_INVESTIGATOR, Children's Oncology Group

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 Date2022-08-04
Study Completion Date2030-06-30

Study Record Updates

Study Start Date2022-08-04
Study Completion Date2030-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Embryonal Rhabdomyosarcoma
  • Fusion-Negative Alveolar Rhabdomyosarcoma
  • Spindle Cell/Sclerosing Rhabdomyosarcoma