Summary

Eligibility
for people ages up to 21 years (full criteria)
Location
at UCLA UCSF
Dates
study started
study ends around
Principal Investigator
by Noah C. Federman (ucla)Jennifer G. Michlitsch (ucsf)Arun A. Rangaswami (ucsf)
Headshot of Noah C. Federman
Noah C. Federman
Headshot of Jennifer G. Michlitsch
Jennifer G. Michlitsch
Headshot of Arun A. Rangaswami
Arun A. Rangaswami

Description

Summary

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

Details

Keywords

Embryonal Rhabdomyosarcoma, Fusion-Negative Alveolar Rhabdomyosarcoma, Spindle Cell/Sclerosing Rhabdomyosarcoma, Rhabdomyosarcoma, Alveolar Rhabdomyosarcoma, Dactinomycin, Cactinomycin, Cyclophosphamide, Vincristine, Biopsy, Bone Scan, Computed Tomography, Magnetic Resonance Elastography, Positron Emission Tomography, Radiation Therapy

Eligibility

Locations

Lead Scientists at University of California Health

  • Noah C. Federman (ucla)
    Dr. Noah Federman is the Director of the Pediatric Bone and Soft Tissue Sarcoma Program at UCLA, part of the UCLA Sarcoma Program and UCLA's Jonsson Comprehensive Cancer Center. Dr. Federman specializes in treating children, adolescents and young adults with these aggressive cancers.
  • Jennifer G. Michlitsch (ucsf)
    Professor, Pediatrics, School of Medicine. Authored (or co-authored) 23 research publications
  • Arun A. Rangaswami (ucsf)
    I am one of the senior solid tumor faculty at UCSF, having joined the institution in 2019. My scholarly and clinical practice have focused on the treatment of pediatric liver cancers and rare cancers.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Children's Oncology Group
ID
NCT05304585
Phase
Phase 3 Rhabdomyosarcoma Research Study
Study Type
Interventional
Participants
Expecting 205 study participants
Last Updated