NCT05813327

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

A Phase I/II Trial of Neoadjuvant ADI-PEG 20 in Combination With Ifosfamide and Radiotherapy in Soft Tissue Sarcoma (STS)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, patients with soft tissue sarcoma (STS) will receive ADI-PEG 20 and ifosfamide in combination with radiation as neoadjuvant therapy. In phase I of the study, up to 5 dose levels will be tested to find the recommended phase II dose (RP2D), after which patients enrolling to phase II will be treated at that dose level to assess efficacy.

Conditions

• Soft Tissue Sarcoma
• Sts
• Sarcoma,Soft Tissue

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-14
• Primary completion: 2026-04-29
• Completion: 2028-05-31
• First posted: 2023-04-14
• Last updated: 2026-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study