Neoadjuvant ADI-PEG 20 + Ifosfamide + Radiotherapy in Soft Tissue Sarcoma

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

March 14, 2024

Primary Completion Date

January 15, 2027

Study Completion Date

January 15, 2029

Conditions
Soft Tissue SarcomaStsSarcoma,Soft Tissue
Interventions
DRUG

ADI PEG20

ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m\^2 via intramuscular injection into either the deltoid or gluteal muscle.

DRUG

Ifosfamide

Ifosfamide will be administered intravenously per package insert and institutional practice on Days 1 through 5 of all 3 cycles.

RADIATION

Radiotherapy

Radiotherapy will begin on C2D1 and will continue as per institutional practice.

DRUG

Mesna

Mesna will be administered for supportive care either intravenously or by mouth per package insert and institutional practice on Days 1 through 5 of all 3 cycles.

Trial Locations (2)

63110

RECRUITING

Washington University School of Medicine, St Louis

80045

RECRUITING

University of Colorado Hospital, Aurora

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Polaris Group

INDUSTRY

lead

Washington University School of Medicine

OTHER

NCT05813327 - Neoadjuvant ADI-PEG 20 + Ifosfamide + Radiotherapy in Soft Tissue Sarcoma | Biotech Hunter | Biotech Hunter