Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma (NCT05304585)

🧪 Interventions in This Study

• Cyclophosphamide (DRUG)
• Dactinomycin (BIOLOGICAL)
• Vincristine (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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).

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (181 Sites)

Showing the first 25 of 181 sites.

• Children's Hospital of Alabama — Birmingham, Alabama
• USA Health Strada Patient Care Center — Mobile, Alabama
• Phoenix Childrens Hospital — Phoenix, Arizona
• Arkansas Children's Hospital — Little Rock, Arkansas
• Kaiser Permanente Downey Medical Center — Downey, California
• Loma Linda University Medical Center — Loma Linda, California
• Miller Children's and Women's Hospital Long Beach — Long Beach, California
• Children's Hospital Los Angeles — Los Angeles, California
• Cedars-Sinai Medical Center — Los Angeles, California
• Mattel Children's Hospital UCLA — Los Angeles, California
• Valley Children's Hospital — Madera, California
• UCSF Benioff Children's Hospital Oakland — Oakland, California
• Kaiser Permanente-Oakland — Oakland, California
• Children's Hospital of Orange County — Orange, California
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California
• University of California Davis Comprehensive Cancer Center — Sacramento, California
• Rady Children's Hospital - San Diego — San Diego, California
• Naval Medical Center -San Diego — San Diego, California
• UCSF Medical Center-Mission Bay — San Francisco, California
• Children's Hospital Colorado — Aurora, Colorado
• Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado
• Connecticut Children's Medical Center — Hartford, Connecticut
• Yale University — New Haven, Connecticut
• Alfred I duPont Hospital for Children — Wilmington, Delaware
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia

📞 Contact the Study Coordinator

Phone: (205) 638-9285

Email: oncologyresearch@peds.uab.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Embryonal Rhabdomyosarcoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.