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Enzyme Depletion

ADI-PEG 20 + Ifosfamide + Radiotherapy for Soft Tissue Sarcoma

Phase 1 & 2

Recruiting

Led By Mia Weiss, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 2 years from surgical resection (estimated to be 120 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial studies a combination of drugs & radiation to treat soft tissue sarcoma before surgery. It will test doses to find the best one, then assess effectiveness.

Who is the study for?

Adults with intermediate or high-grade soft tissue sarcoma of the trunk/extremities, size ≥5 cm, planning curative surgery. Must be 18+, have normal organ/bone marrow function, no distant metastasis, and agree to contraception. Excludes those with prior radiotherapy in the area, significant recent bleeding or heart issues, active infections needing IV antibiotics, pregnant/breastfeeding women, known Hepatitis B/C or HIV.

What is being tested?

The trial tests ADI-PEG 20 plus Ifosfamide combined with Radiotherapy as a pre-surgery treatment for soft tissue sarcoma. Phase I determines the safest dose level; Phase II assesses its effectiveness at that dose.

What are the potential side effects?

Possible side effects include reactions related to immune system activation (like inflammation), fatigue from radiation therapy and chemotherapy drugs like Ifosfamide which can also cause blood disorders and increase infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2 years from surgical resection (estimated to be 120 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 2 years from surgical resection (estimated to be 120 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 years from surgical resection (estimated to be 120 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recommended Phase II dose (Phase I only)

Treatment-related serious adverse event (SAE) rate

Secondary study objectives

Disease free survival (DFS)

Overall survival (OS)

Pathologic complete response (pCR) in final surgical specimen

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase II: ADI-PEG 20 + ifosfamide + radiotherapyExperimental Treatment4 Interventions

Patients will receive ADI-PEG 20 on Day -7 of Cycle 1 and Days 1, 8, and 15 of each of three 21-day cycles, and ifosfamide per the RP2D determined in Phase I of the study on days 1 through 5 of each cycle. Mesna will be given on days 1 through 5 with ifosfamide as supportive care. Patients will also receive radiotherapy (XRT) starting on Week 4.

Group II: Phase I: ADI-PEG 20 + ifosfamide + radiotherapyExperimental Treatment4 Interventions

Patients will receive ADI-PEG 20 on Day -7 of Cycle 1 and Days 1, 8, and 15 of each of three 21-day cycles, and ifosfamide per dose escalation/de-escalation schedule on days 1 through 5 of each cycle. Mesna will be given on days 1 through 5 with ifosfamide as supportive care. Patients will also receive radiotherapy (XRT) starting on Week 4.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ifosfamide

2010

Completed Phase 4

~3350

ADI PEG20

2019

Completed Phase 1

~10