NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

139

Participants

Timeline

Start Date

March 27, 2024

Primary Completion Date

June 30, 2034

Study Completion Date

June 30, 2037

Conditions
Adipocytic NeoplasmLiposarcomaAtypical FibroxanthomaAngiomatoid Fibrous HistiocytomaMyoepitheliomaFibrosarcoma NOSMyxofibrosarcomaAngiosarcomaOsteosarcoma, Extraskeletal
Interventions
PROCEDURE

Surgical resection

Low, Intermediate and High-risk Surgery to remove tumor (standard of care)

RADIATION

Proton beam radiation therapy

Low, Intermediate and High-risk Radiation therapy is considered standard of care for patients with NRSTS who have positive tumor margins. However, the dose that will be given in this study is higher than what is usually given, therefore, the dose of radiation in this study is research. Radiation will start about 3 to 6 weeks after your surgery, depending on how quickly you recover from surgery. Radiation will be given daily (Monday through Friday) for about 5 to 6 weeks.

DRUG

Pazopanib

Intermediate and High-risk By mouth, either by tablet or a liquid suspension, 7 doses, days 1 to 7

DRUG

Ifosfamide

Intermediate and High-risk Ifosfamide is a structural analogue of cyclophosphamide. Into the vein (IV) over about 3 hours, 3 doses, days 1, 2, and 3

DRUG

Doxorubicin

Intermediate and High-risk An anthracycline antibiotic isolated from cultures of Streptomyces peucetius. Intermediate, High-risk Into the vein (IV) over about 1 hour, 2 doses, days 1 and 2

DRUG

Selinexor

"High-risk Dosage and route of administration: Selinexor tablets for oral administration should be taken at approximately the same time each day without regards to meals.~Selinexor is a selective inhibitor of nuclear export (SINE). Selinexor specifically blocks XPO1-mediated nuclear export by forming a slowly reversible covalent bond with the nuclear export protein XPO1 By mouth, either by tablet or a liquid suspension, 1 dose and day 3"

Trial Locations (4)

38105

RECRUITING

St. Jude Children's Research Hospital, Memphis

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

63110

RECRUITING

Washington University Medical Center, St Louis

70809

RECRUITING

Our Lady of the Lake Children's Hospital, Baton Rouge

All Listed Sponsors
lead

St. Jude Children's Research Hospital

OTHER