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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
Study 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.Check my eligibility
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.See study design
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended Phase II dose (Phase I only)
Treatment-related serious adverse event (SAE) rate
Secondary outcome measures
Disease free survival (DFS)
Overall survival (OS)
Pathologic complete response (pCR) in final surgical specimen
+3 moreTrial 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
ADI PEG20
2019
Completed Phase 1
~10
Ifosfamide
2010
Completed Phase 4
~2980
Radiotherapy
2017
Completed Phase 3
~2610
Mesna
2003
Completed Phase 2
~1380
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,660 Total Patients Enrolled
Polaris GroupIndustry Sponsor
24 Previous Clinical Trials
3,252 Total Patients Enrolled
Mia Weiss, M.D.Principal InvestigatorWashington University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have enough tumor tissue available for analysis, or I have received special permission to enroll without it.I have a grade 2-3 soft tissue sarcoma larger than 5 cm and plan to treat it with the goal of curing it.I have not had chemotherapy for my current sarcoma but may have had it for another cancer over three years ago.My cancer is a specific type of sarcoma but not bone or cartilage sarcoma.I am not taking any medications that are not allowed in the study.I've had radiation in the same area as my current cancer.I have a serious heart condition.I have active Hepatitis B, C, or HIV.My scans show cancer has spread, but any lung spots are smaller than 5mm.My cancer hasn't spread far and surgery is planned to remove the main tumor.I am 18 years old or older.I am fully active or can carry out light work.My blood, liver, and kidney functions meet the required levels for treatment.I am allergic to ADI-PEG 20, ifosfamide, PEGylated compounds, or similar medications.I haven't needed IV antibiotics for an infection in the last 2 weeks.I haven't had major bleeding recently and can stop blood thinners before treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I: ADI-PEG 20 + ifosfamide + radiotherapy
- Group 2: Phase II: ADI-PEG 20 + ifosfamide + radiotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What objectives is this scientific trial attempting to accomplish?
"This trial will assess the Recommended Phase II dose (Phase I only) over a period of 14 weeks. Secondary objectives include measuring Pathologic complete response, Percent local failure and Disease free survival."
Answered by AI
Are there any openings remaining for participation in this research trial?
"The clinicaltrial.gov website states that this medical trial is not actively recruiting patients; it was initially advertised on July 31st 2023 and amended most recently on April 2nd 2023. However, 448 other trials are currently in search of volunteers."
Answered by AI
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