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Search / Trial NCT05304585

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

Launched by CHILDREN'S ONCOLOGY GROUP · Mar 28, 2022

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the use of chemotherapy to treat children and young adults with newly diagnosed very low-risk and low-risk forms of rhabdomyosarcoma, a type of cancer that affects soft tissues. The goal is to maintain good treatment outcomes while reducing the amount of chemotherapy needed. Participants will receive a specific treatment plan involving two chemotherapy drugs, vincristine and dactinomycin, for 24 weeks. The study also aims to understand how patients with different types of rhabdomyosarcoma respond to treatment and whether those with certain DNA mutations need more intensive therapy for better results.

To be eligible for this trial, patients must be 21 years old or younger and have a newly diagnosed case of specific types of rhabdomyosarcoma. They should not have received any prior chemotherapy or radiation for cancer. Throughout the trial, participants will undergo regular health assessments to monitor their response to treatment and any side effects. Parents and guardians will need to provide consent for their children to participate. This study is currently recruiting participants, and it aims to help improve treatment strategies for young patients facing this type of cancer.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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).
  • Patients must be =\< 21 years at the time of enrollment.
  • 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.
  • 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.
  • Patients will be eligible for the very low-risk stratum (Regimen VA) if they have Stage 1, CG I disease.
  • 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.
  • 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.
  • Extremity Tumors: Regional lymph node sampling is required for histologic evaluation in patients with extremity tumors.
  • Clinically or radiographically enlarged nodes must be sampled for histologic evaluation.
  • 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.
  • Peripheral absolute neutrophil count (ANC) \>= 750/uL (within 7 days prior to enrollment).
  • Platelet count \>= 75,000/uL (transfusion independent) (within 7 days prior to enrollment).
  • * 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:
  • Age: 1 month to \< 6 months; Maximum serum creatinine (mg/dL): 0.4 (male) : 0.4 (female)
  • Age: 6 months to \< 1 year; Maximum serum creatinine (mg/dL): 0.5 (male) : 0.5 (female)
  • Age: 1 to \< 2 years; Maximum serum creatinine (mg/dL): 0.6 (male) : 0.6 (female)
  • Age: 2 to \< 6 years; Maximum serum creatinine (mg/dL): 0.8 (male) : 0.8 (female)
  • Age: 6 to \< 10 years; Maximum serum creatinine (mg/dL): 1 (male) : 1 (female)
  • Age: 10 to \< 13 years; Maximum serum creatinine (mg/dL): 1.2 (male) : 1.2 (female)
  • Age: 13 to \< 16 years; Maximum serum creatinine (mg/dL): 1.5 (male) : 1.4 (female)
  • Age \>= 16 years; Maximum serum creatinine (mg/dL): 1.7 (male) : 1.4 (female)
  • Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment), and
  • If there is evidence of biliary obstruction by the tumor, then the total bilirubin must be \< 3 x ULN for age.
  • Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L.
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L
  • If there is evidence of biliary obstruction by the tumor, then the total bilirubin must be \< 3 x ULN for age
  • Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
  • 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.
  • Exclusion Criteria:
  • Patients who have received prior chemotherapy and/or radiation therapy for cancer prior to enrollment. Surgical resection alone of previous cancer(s) is permitted.
  • 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.
  • 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.
  • Patients unable to undergo radiation therapy, if necessary, as specified in the protocol.
  • Evidence of uncontrolled infection.
  • 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.
  • Lactating females who plan to breastfeed their infants.
  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.

About Children's Oncology Group

The Children's Oncology Group (COG) is a leading national organization dedicated to improving the care and outcomes of children with cancer through collaborative research and clinical trials. Comprising a network of pediatric oncology experts, COG focuses on developing innovative treatment protocols, advancing scientific knowledge, and enhancing the quality of life for young patients. By fostering interdisciplinary collaboration and utilizing a comprehensive approach to childhood cancer, COG aims to translate research findings into effective therapies, ultimately striving for a cure for all children diagnosed with cancer.

Locations

New Haven, Connecticut, United States

Durham, North Carolina, United States

Cleveland, Ohio, United States

Philadelphia, Pennsylvania, United States

Buffalo, New York, United States

Saint Louis, Missouri, United States

Detroit, Michigan, United States

Providence, Rhode Island, United States

Dallas, Texas, United States

Kalamazoo, Michigan, United States

Maywood, Illinois, United States

Boston, Massachusetts, United States

Loma Linda, California, United States

Newark, New Jersey, United States

Valhalla, New York, United States

Winnipeg, Manitoba, Canada

Hackensack, New Jersey, United States

Edmonton, Alberta, Canada

Vancouver, British Columbia, Canada

Peoria, Illinois, United States

Wichita, Kansas, United States

Oklahoma City, Oklahoma, United States

Temple, Texas, United States

Toronto, Ontario, Canada

Orange, California, United States

Scarborough, Maine, United States

Akron, Ohio, United States

Lubbock, Texas, United States

Norfolk, Virginia, United States

Randwick, New South Wales, Australia

New York, New York, United States

Baltimore, Maryland, United States

Little Rock, Arkansas, United States

Des Moines, Iowa, United States

Jackson, Mississippi, United States

Minneapolis, Minnesota, United States

Austin, Texas, United States

Corpus Christi, Texas, United States

Calgary, Alberta, Canada

Quebec, , Canada

Hershey, Pennsylvania, United States

Charlottesville, Virginia, United States

Houston, Texas, United States

Tacoma, Washington, United States

San Antonio, Texas, United States

Springfield, Illinois, United States

Cincinnati, Ohio, United States

San Antonio, Texas, United States

Boston, Massachusetts, United States

Los Angeles, California, United States

Rochester, New York, United States

Danville, Pennsylvania, United States

San Diego, California, United States

Washington, District Of Columbia, United States

Orlando, Florida, United States

Savannah, Georgia, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Iowa City, Iowa, United States

New Orleans, Louisiana, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Minneapolis, Minnesota, United States

Omaha, Nebraska, United States

New York, New York, United States

New York, New York, United States

Syracuse, New York, United States

Chapel Hill, North Carolina, United States

Winston Salem, North Carolina, United States

Fargo, North Dakota, United States

Nashville, Tennessee, United States

Birmingham, Alabama, United States

Hartford, Connecticut, United States

Indianapolis, Indiana, United States

Lexington, Kentucky, United States

Charlotte, North Carolina, United States

Allentown, Pennsylvania, United States

Falls Church, Virginia, United States

Washington, District Of Columbia, United States

Honolulu, Hawaii, United States

Portland, Oregon, United States

Pensacola, Florida, United States

Grand Rapids, Michigan, United States

Cleveland, Ohio, United States

Phoenix, Arizona, United States

Oakland, California, United States

San Diego, California, United States

Aurora, Colorado, United States

Wilmington, Delaware, United States

Fort Lauderdale, Florida, United States

Hollywood, Florida, United States

Jacksonville, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

Tampa, Florida, United States

West Palm Beach, Florida, United States

Chicago, Illinois, United States

Ann Arbor, Michigan, United States

Saint Louis, Missouri, United States

New Brunswick, New Jersey, United States

Albany, New York, United States

New Hyde Park, New York, United States

Charlotte, North Carolina, United States

Greenville, North Carolina, United States

Columbus, Ohio, United States

Dayton, Ohio, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Sioux Falls, South Dakota, United States

Knoxville, Tennessee, United States

Dallas, Texas, United States

Fort Worth, Texas, United States

Houston, Texas, United States

Salt Lake City, Utah, United States

Richmond, Virginia, United States

Seattle, Washington, United States

Spokane, Washington, United States

Tacoma, Washington, United States

Montreal, Quebec, Canada

Grafton, Auckland, New Zealand

Christchurch, , New Zealand

Downey, California, United States

Long Beach, California, United States

Madera, California, United States

Oakland, California, United States

Palo Alto, California, United States

San Francisco, California, United States

Denver, Colorado, United States

Fort Myers, Florida, United States

Gainesville, Florida, United States

Orlando, Florida, United States

Orlando, Florida, United States

Saint Petersburg, Florida, United States

Atlanta, Georgia, United States

Oak Lawn, Illinois, United States

Indianapolis, Indiana, United States

Louisville, Kentucky, United States

Rochester, Minnesota, United States

Kansas City, Missouri, United States

Saint Louis, Missouri, United States

Omaha, Nebraska, United States

Las Vegas, Nevada, United States

Bronx, New York, United States

Toledo, Ohio, United States

Columbia, South Carolina, United States

Greenville, South Carolina, United States

Memphis, Tennessee, United States

Roanoke, Virginia, United States

Madison, Wisconsin, United States

Marshfield, Wisconsin, United States

Milwaukee, Wisconsin, United States

Westmead, New South Wales, Australia

Montreal, Quebec, Canada

Little Rock, Arkansas, United States

Los Angeles, California, United States

Worcester, Massachusetts, United States

Reno, Nevada, United States

Albuquerque, New Mexico, United States

Mobile, Alabama, United States

Los Angeles, California, United States

Pensacola, Florida, United States

Boise, Idaho, United States

Royal Oak, Michigan, United States

Charleston, West Virginia, United States

Sherbrooke, Quebec, Canada

Park Ridge, Illinois, United States

Las Vegas, Nevada, United States

San Antonio, Texas, United States

Perth, Western Australia, Australia

Winfield, Illinois, United States

Halifax, Nova Scotia, Canada

Nashville, Tennessee, United States

Lubbock, Texas, United States

El Paso, Texas, United States

Saint Louis, Missouri, United States

Indianapolis, Indiana, United States

Lebanon, New Hampshire, United States

West Palm Beach, Florida, United States

Quebec, , Canada

Madison, Wisconsin, United States

Grand Rapids, Michigan, United States

Royal Oak, Michigan, United States

Atlanta, Georgia, United States

Patients applied

0 patients applied

Trial Officials

Josephine H Haduong

Principal Investigator

Children's Oncology Group

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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