Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

115

Participants

Timeline

Start Date

December 4, 2013

Primary Completion Date

December 31, 2025

Study Completion Date

June 30, 2030

Conditions
Rhabdomyosarcoma
Interventions
DRUG

Vincristine

"Dosage and route of administration:~* \< 1 year of age=0.025 mg/kg intravenously (IV)~* \> 1 year and \< 3 years= 0.05 mg/kg IV~* ≥ 3 years=1.5 mg/m\^2 IV. Maximum dose 2 mg in all participants."

DRUG

Dactinomycin

"Dosage and route of administration:~* \< 1 year=0.025 mg/kg IV push~* ≥ 1 year=0.045 mg/kg IV push over 1 to 5 minutes."

DRUG

Cyclophosphamide

"Dosage and route of administration:~During VAC chemotherapy:~* \< 3 years of age = 40 mg/kg IV~* ≥ 3 years of age = 1200 mg/m\^2 IV, with MESNA.~During maintenance for intermediate-risk participants:~* oral cyclophosphamide 50 mg/m\^2/dose/day (liquid or tablet)"

PROCEDURE

Surgical Resection

Surgery will be performed for the primary site tumor with the goal of removing tumor cells while maintaining function in the organ or adjacent organs involved.

PROCEDURE

Radiation

Radiation therapy will be delivered at approximately week 13 (intermediate risk) or week 19 (high risk) after initiation of chemotherapy. Certain patients will receive radiation at week 4.

DRUG

Bevacizumab

Dosage and route of administration: 15 mg/kg/dose/day IV.

DRUG

Sorafenib

Dosage and route of administration: 90 mg/m\^2/dose twice daily.

DRUG

Myeloid Growth Factor

"If a participant's chemotherapy has been delayed or modified for hematologic toxicity, or if participant experiences a significant life-threatening toxicity due to bone marrow suppression, myeloid growth factor (either filgrastim or peg-filgrastim) will be given per institutional practice.~High Risk participants receive filgrastim 5 micrograms/kg/day (maximum 300 micrograms) subcutaneously beginning 24-36 hours after the last dose of chemotherapy. Continue at least 7 days, or until the ANC ≥750/µL whichever comes last. Sargramostim or peg-filgrastim may not be used."

PROCEDURE

Lymph Node Sampling

"Clinical and/or imaging evaluation of regional lymph nodes will be conducted pretreatment and preoperatively as part of staging. This will aid in determining the efficacy of this procedure in defining involved lymphatics in at risk patients."

DRUG

Irinotecan

Dosage and Route Administration: During interval compressed therapy - irinotecan 50mg/m\^2 IV (maximum dose 100 mg/day) daily x 5.

DRUG

Ifosfamide

Dosage and Route of Administration: During interval compressed therapy - Age \> 1 year: 1800 mg/m\^2/day IV x 5 Age \<1 year: treat with 50% doses calculated on a m\^2 basis.

DRUG

Etoposide

"Dosage and Route of Administration:~Age \>1 year 100 mg/m\^2/day IV x 5 Age \< 1 year treat with 50% doses calculated on a m\^2 basis"

DRUG

Etoposide Phosphate

Dosage and Route of Administration: Used in substitution for etoposide in participants who experience allergic reaction. It will be administered 100 mg/m\^2/day IV.

DRUG

Doxorubicin

"Dosage and route of Administration:~Age ≥1 year, 37.5 mg/m\^2 IV over 1 hour x 2 days Age \<1 year, 18.75 mg/m\^2 (i.e., a 50% dose reduction) IV over 1 hour x 2 days."

DRUG

Dexrazoxane

"Dosage and Route of Administration: Dexrazoxane dose should be 10x that of doxorubicin.~Age ≥1 year, 375 mg/m\^2 IV over 15-30 minutes Age \<1 year, 187l.5 mg/m\^2 (i.e., a 50% dose reduction) IV over 15-30 minutes."

DRUG

^1^1C-methionine

Participants receive \^1\^1C-methionine to relate the distribution, intensity and change in \^1\^1C-methionine CTPET imaging of the primary site to tumor control and patient outcome.

Trial Locations (4)

32206

University of Florida Proton Therapy Institute, Jacksonville

32207

Nemours Children's Clinic, Jacksonville

38105

St. Jude Children's Research Hospital, Memphis

76104

Cook Children's Medical Center, Fort Worth

All Listed Sponsors
lead

St. Jude Children's Research Hospital

OTHER