A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy With Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) Plus VINO-CPO Maintenance in Patients With High Risk Rhabdomyosarcoma (HR-RMS)

Who is this study for? Patients with Rhabdomyosarcoma
What treatments are being studied? Cyclophosphamide+Dactinomycin+Radiation Therapy+Vincristine Sulfate+Vinorelbine Tartrate
Status: Recruiting
Location: See all (192) locations...
Intervention Type: Drug, Biological, Radiation
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This phase III trial compares the safety and effect of adding vinorelbine to vincristine, dactinomycin, and cyclophosphamide (VAC) for the treatment of patients with high risk rhabdomyosarcoma (RMS). High risk refers to cancer that is likely to recur (come back) after treatment or spread to other parts of the body. This study will also examine if adding maintenance therapy after VAC therapy, with or without vinorelbine, will help get rid of the cancer and/or lower the chance that the cancer comes back. Vinorelbine and vincristine are in a class of medications called vinca alkaloids. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy. Cyclophosphamide is in a class of medications called alkylating agents. Vinorelbine, vincristine, dactinomycin and cyclophosphamide are chemotherapy medications that work by slowing or stopping the growth of cancer cells in the body. This trial may have the potential to eliminate rhabdomyosarcoma for a long time or for the rest of patient's life.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 50
Healthy Volunteers: No
View:

• Patients must be =< 50 years of age at the time of enrollment

• Patients with newly diagnosed RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification are eligible to enroll on the study based upon Stage, Group, and age, as below. FOXO1 fusion status must be determined by week 4 (day 28) of therapy. RMS types included under embryonal RMS (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). Classification of alveolar RMS (ARMS) in the 2020 WHO Classification is the same as in the ICR and includes classic and solid variants

• ERMS

• Stage 4, group IV, >= 10 years of age

• ARMS

• Stage 4, group IV Patients will be eligible to remain on protocol therapy based upon stage, group, and age

• Bone marrow metastatic disease is based on morphologic evidence of RMS based on hematoxylin and eosin (H&E) stains. In the absence of morphologic evidence of marrow involvement on H&E, patients with bone marrow involvement detected ONLY by flow cytometry, reverse transcriptase (RT)-polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or immunohistochemistry will NOT be considered to have clinical bone marrow involvement for the purposes of this study

• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows (must be performed within 7 days prior to enrollment):

• Age; Maximum serum creatinine (mg/dL)

• 1 month to < 6 months; 0.4 mg/dL (male); 0.4 mg/dL (female)

• 6 months to < 1 year; 0.5 mg/dL (male); 0.5 mg/dL (female)

• 1 to < 2 years; 0.6 mg/dL (male); 0.6 mg/dL (female)

• >= 16 years; 1.7 mg/dL (male); 1.4 mg/dL (female)

• Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (must be performed within 7 days prior to enrollment)

• If there is evidence of biliary obstruction by tumor, then total bilirubin must be < 3 x ULN for age

• All patients and/or their parents or legal guardians must sign a written informed consent

• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Locations
United States
Alaska
Providence Alaska Medical Center
Suspended
Anchorage
Alabama
Children's Hospital of Alabama
Suspended
Birmingham
USA Health Strada Patient Care Center
Suspended
Mobile
Arkansas
Arkansas Children's Hospital
Suspended
Little Rock
Arizona
Banner Children's at Desert
Suspended
Mesa
Banner University Medical Center - Tucson
Suspended
Tucson
California
PCR Oncology
Suspended
Arroyo Grande
Miller Children's and Women's Hospital Long Beach
Suspended
Long Beach
Children's Hospital Los Angeles
Suspended
Los Angeles
Mattel Children's Hospital UCLA
Suspended
Los Angeles
Valley Children's Hospital
Suspended
Madera
Kaiser Permanente-Oakland
Suspended
Oakland
Children's Hospital of Orange County
Suspended
Orange
Lucile Packard Children's Hospital Stanford University
Suspended
Palo Alto
University of California Davis Comprehensive Cancer Center
Suspended
Sacramento
Rady Children's Hospital - San Diego
Not yet recruiting
San Diego
Colorado
Children's Hospital Colorado
Suspended
Aurora
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Suspended
Denver
Connecticut
Connecticut Children's Medical Center
Suspended
Hartford
Washington, D.c.
Children's National Medical Center
Suspended
Washington
MedStar Georgetown University Hospital
Suspended
Washington
Delaware
Alfred I duPont Hospital for Children
Suspended
Wilmington
Florida
Broward Health Medical Center
Suspended
Fort Lauderdale
Golisano Children's Hospital of Southwest Florida
Suspended
Fort Myers
University of Florida Health Science Center - Gainesville
Suspended
Gainesville
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Suspended
Hollywood
Nemours Children's Clinic-Jacksonville
Suspended
Jacksonville
Arnold Palmer Hospital for Children
Suspended
Orlando
Nemours Children's Hospital
Suspended
Orlando
Saint Joseph's Hospital/Children's Hospital-Tampa
Suspended
Tampa
Tampa General Hospital
Suspended
Tampa
Saint Mary's Hospital
Suspended
West Palm Beach
Georgia
Memorial Health University Medical Center
Suspended
Savannah
Hawaii
Kapiolani Medical Center for Women and Children
Suspended
Honolulu
Iowa
Blank Children's Hospital
Suspended
Des Moines
University of Iowa/Holden Comprehensive Cancer Center
Suspended
Iowa City
Idaho
Saint Luke's Cancer Institute - Boise
Suspended
Boise
Illinois
Lurie Children's Hospital-Chicago
Suspended
Chicago
University of Chicago Comprehensive Cancer Center
Suspended
Chicago
University of Illinois
Suspended
Chicago
Loyola University Medical Center
Suspended
Maywood
Advocate Children's Hospital-Oak Lawn
Suspended
Oak Lawn
Advocate Children's Hospital-Park Ridge
Suspended
Park Ridge
Saint Jude Midwest Affiliate
Suspended
Peoria
Saint John's Hospital
Suspended
Springfield
Southern Illinois University School of Medicine
Suspended
Springfield
Indiana
Riley Hospital for Children
Suspended
Indianapolis
Kentucky
University of Kentucky/Markey Cancer Center
Recruiting
Lexington
Louisiana
Ochsner Medical Center Jefferson
Suspended
New Orleans
Massachusetts
Dana-Farber Cancer Institute
Suspended
Boston
Massachusetts General Hospital Cancer Center
Suspended
Boston
Tufts Children's Hospital
Active, not recruiting
Boston
Tufts Medical Center
Active, not recruiting
Boston
UMass Memorial Medical Center - University Campus
Suspended
Worcester
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Suspended
Baltimore
Sinai Hospital of Baltimore
Suspended
Baltimore
Walter Reed National Military Medical Center
Suspended
Bethesda
Maine
Maine Children's Cancer Program
Suspended
Scarborough
Michigan
C S Mott Children's Hospital
Suspended
Ann Arbor
Bronson Battle Creek
Suspended
Battle Creek
Michigan State University Clinical Center
Suspended
East Lansing
Helen DeVos Children's Hospital at Spectrum Health
Suspended
Grand Rapids
Mercy Health Saint Mary's
Suspended
Grand Rapids
Spectrum Health at Butterworth Campus
Suspended
Grand Rapids
Borgess Medical Center
Suspended
Kalamazoo
Bronson Methodist Hospital
Suspended
Kalamazoo
West Michigan Cancer Center
Suspended
Kalamazoo
Mercy Health Mercy Campus
Suspended
Muskegon
Lakeland Hospital Niles
Suspended
Niles
Cancer and Hematology Centers of Western Michigan - Norton Shores
Suspended
Norton Shores
Spectrum Health Reed City Hospital
Suspended
Reed City
Beaumont Children's Hospital-Royal Oak
Suspended
Royal Oak
Lakeland Medical Center Saint Joseph
Suspended
Saint Joseph
Marie Yeager Cancer Center
Suspended
Saint Joseph
Munson Medical Center
Suspended
Traverse City
Metro Health Hospital
Suspended
Wyoming
Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis
Suspended
Minneapolis
Mayo Clinic in Rochester
Suspended
Rochester
Missouri
Children's Mercy Hospitals and Clinics
Suspended
Kansas City
Mercy Hospital Saint Louis
Suspended
Saint Louis
Washington University School of Medicine
Suspended
Saint Louis
Mississippi
University of Mississippi Medical Center
Suspended
Jackson
North Carolina
Mission Hospital
Suspended
Asheville
Novant Health Presbyterian Medical Center
Suspended
Charlotte
East Carolina University
Suspended
Greenville
Wake Forest University Health Sciences
Suspended
Winston-salem
North Dakota
Sanford Broadway Medical Center
Suspended
Fargo
Nebraska
Children's Hospital and Medical Center of Omaha
Suspended
Omaha
University of Nebraska Medical Center
Suspended
Omaha
New Jersey
Hackensack University Medical Center
Suspended
Hackensack
Morristown Medical Center
Suspended
Morristown
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Suspended
New Brunswick
Saint Joseph's Regional Medical Center
Suspended
Paterson
Nevada
Comprehensive Cancer Centers of Nevada - Henderson
Suspended
Henderson
OptumCare Cancer Care at Seven Hills
Suspended
Henderson
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Suspended
Las Vegas
Comprehensive Cancer Centers of Nevada
Suspended
Las Vegas
Comprehensive Cancer Centers of Nevada - Central Valley
Suspended
Las Vegas
Comprehensive Cancer Centers of Nevada - Northwest
Suspended
Las Vegas
Comprehensive Cancer Centers of Nevada - Town Center
Suspended
Las Vegas
Comprehensive Cancer Centers of Nevada-Summerlin
Suspended
Las Vegas
GenesisCare USA - Las Vegas
Suspended
Las Vegas
OptumCare Cancer Care at Charleston
Suspended
Las Vegas
OptumCare Cancer Care at Fort Apache
Suspended
Las Vegas
OptumCare Cancer Care at MountainView
Suspended
Las Vegas
Radiation Oncology Centers of Nevada Central
Suspended
Las Vegas
Radiation Oncology Centers of Nevada Southeast
Suspended
Las Vegas
Cancer Care Specialists - Reno
Suspended
Reno
Radiation Oncology Associates
Suspended
Reno
Renown Regional Medical Center
Suspended
Reno
Saint Mary's Regional Medical Center
Suspended
Reno
New York
Albany Medical Center
Suspended
Albany
Maimonides Medical Center
Suspended
Brooklyn
Roswell Park Cancer Institute
Suspended
Buffalo
The Steven and Alexandra Cohen Children's Medical Center of New York
Suspended
New Hyde Park
Memorial Sloan Kettering Cancer Center
Suspended
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Recruiting
New York
NYP/Weill Cornell Medical Center
Suspended
New York
Stony Brook University Medical Center
Suspended
Stony Brook
State University of New York Upstate Medical University
Suspended
Syracuse
New York Medical College
Suspended
Valhalla
Ohio
Cincinnati Children's Hospital Medical Center
Suspended
Cincinnati
Cleveland Clinic Foundation
Suspended
Cleveland
Rainbow Babies and Childrens Hospital
Suspended
Cleveland
Nationwide Children's Hospital
Suspended
Columbus
Dayton Children's Hospital
Suspended
Dayton
ProMedica Flower Hospital
Suspended
Sylvania
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Suspended
Toledo
Oklahoma
University of Oklahoma Health Sciences Center
Suspended
Oklahoma City
Oregon
Legacy Emanuel Children's Hospital
Suspended
Portland
Oregon Health and Science University
Suspended
Portland
Pennsylvania
Geisinger Medical Center
Suspended
Danville
Penn State Children's Hospital
Suspended
Hershey
Children's Hospital of Philadelphia
Suspended
Philadelphia
Children's Oncology Group
Not yet recruiting
Philadelphia
Children's Hospital of Pittsburgh of UPMC
Suspended
Pittsburgh
Rhode Island
Rhode Island Hospital
Suspended
Providence
South Carolina
Prisma Health Richland Hospital
Suspended
Columbia
BI-LO Charities Children's Cancer Center
Suspended
Greenville
Prisma Health Cancer Institute - Eastside
Suspended
Greenville
Prisma Health Cancer Institute - Faris
Suspended
Greenville
Prisma Health Cancer Institute - Greer
Suspended
Greer
Prisma Health Cancer Institute - Seneca
Suspended
Seneca
South Dakota
Sanford USD Medical Center - Sioux Falls
Suspended
Sioux Falls
Tennessee
T C Thompson Children's Hospital
Suspended
Chattanooga
East Tennessee Childrens Hospital
Suspended
Knoxville
The Children's Hospital at TriStar Centennial
Suspended
Nashville
Vanderbilt University/Ingram Cancer Center
Suspended
Nashville
Texas
Texas Tech University Health Sciences Center-Amarillo
Suspended
Amarillo
Dell Children's Medical Center of Central Texas
Suspended
Austin
Driscoll Children's Hospital
Suspended
Corpus Christi
Medical City Dallas Hospital
Suspended
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Not yet recruiting
Dallas
El Paso Children's Hospital
Suspended
El Paso
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Suspended
Houston
M D Anderson Cancer Center
Suspended
Houston
UMC Cancer Center / UMC Health System
Suspended
Lubbock
Children's Hospital of San Antonio
Suspended
San Antonio
Methodist Children's Hospital of South Texas
Suspended
San Antonio
University of Texas Health Science Center at San Antonio
Suspended
San Antonio
Utah
Primary Children's Hospital
Suspended
Salt Lake City
Virginia
Inova Fairfax Hospital
Suspended
Falls Church
Children's Hospital of The King's Daughters
Suspended
Norfolk
Virginia Commonwealth University/Massey Cancer Center
Suspended
Richmond
Carilion Children's
Suspended
Roanoke
Washington
Overlake Medical Center
Suspended
Bellevue
Valley Medical Center
Suspended
Renton
Seattle Children's Hospital
Suspended
Seattle
Providence Sacred Heart Medical Center and Children's Hospital
Suspended
Spokane
Madigan Army Medical Center
Suspended
Tacoma
Mary Bridge Children's Hospital and Health Center
Suspended
Tacoma
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Suspended
Yakima
Wisconsin
University of Wisconsin Carbone Cancer Center
Suspended
Madison
Marshfield Medical Center-Marshfield
Suspended
Marshfield
West Virginia
West Virginia University Charleston Division
Suspended
Charleston
Other Locations
Australia
John Hunter Children's Hospital
Suspended
Hunter Regional Mail Centre
Royal Children's Hospital
Suspended
Parkville
Perth Children's Hospital
Suspended
Perth
The Children's Hospital at Westmead
Suspended
Westmead
Canada
Alberta Children's Hospital
Suspended
Calgary
University of Alberta Hospital
Suspended
Edmonton
IWK Health Centre
Suspended
Halifax
McMaster Children's Hospital at Hamilton Health Sciences
Suspended
Hamilton
Children's Hospital
Suspended
London
Centre Hospitalier Universitaire Sainte-Justine
Suspended
Montreal
The Montreal Children's Hospital of the MUHC
Suspended
Montreal
Children's Hospital of Eastern Ontario
Suspended
Ottawa
Jim Pattison Children's Hospital
Suspended
Saskatoon
Saskatoon Cancer Centre
Active, not recruiting
Saskatoon
Hospital for Sick Children
Suspended
Toronto
CancerCare Manitoba
Suspended
Winnipeg
Puerto Rico
HIMA San Pablo Oncologic Hospital
Suspended
Caguas
Time Frame
Start Date: September 13, 2021
Estimated Completion Date: June 30, 2028
Participants
Target number of participants: 8
Treatments
Experimental: Arm A (VAC, VINO-CPO)
Patients receive vincristine sulfate IV on days 1, 8 and 15 of cycles 1-4, 7, 8, 11, and 12, and day 1 of cycles 5, 6, 9, 10, 13, and 14. Patients also receive dactinomycin IV over 1-15 minutes on day 1 of cycles 1-5, 8-10, and 11-14, and cyclophosphamide IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy on weeks 13 and 40.~MAINTENANCE: Patients receive vinorelbine tartrate IV over 6-10 minutes on days 1, 8, and 15, and cyclophosphamide PO on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Experimental: Arm B (vinorelbine, VAC, VINO-CPO)
Patients receive vinorelbine tartrate IV over 6-10 minutes on days 1 and 8, vincristine sulfate IV on day 15, dactinomycin IV over 1-15 minutes on day 1 of cycles 1-5 and 8-14, and cyclophosphamide IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy on weeks 13 and 40.~MAINTENANCE: Patients receive vinorelbine tartrate IV over 6-10 minutes on days 1, 8, and 15, and cyclophosphamide PO on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Sponsors
Leads: Children's Oncology Group

This content was sourced from clinicaltrials.gov

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