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Anti-metabolites

pegylated arginine deiminase for Soft Tissue Sarcoma

Phase 2

Waitlist Available

Led By Brian A Van Tine, M.D., Ph.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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of treatment (median treatment of 9 months)

Awards & highlights

Study Summary

This trial will study whether the addition of ADI-PEG20 to gemcitabine and docetaxel will improve the overall response rate in patients with advanced soft tissue sarcomas.

Eligible Conditions

Soft Tissue Sarcoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of treatment (median treatment of 9 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through completion of treatment (median treatment of 9 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of treatment (median treatment of 9 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free Survival (PFS) (Cohort 1 Only)

Secondary outcome measures

Clinical Benefit Rate (CBR) (Cohort 1 Only)

Number of Participants With Cancer-related Mortality (Cohort 1 Only)

Overall Survival (OS) (Cohort 1 Only)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2: ADI-PEG 20 + Gemcitabine + DocetaxelExperimental Treatment5 Interventions

ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle. Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request. Treatment may continue for up to 34 cycles (103 weeks)

Group II: Cohort 1: ADI-PEG 20 + Gemcitabine + DocetaxelExperimental Treatment5 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

pegylated arginine deiminase

2018

Completed Phase 2

~100

Docetaxel

1995

Completed Phase 4

~5620

Tumor biopsy

2014

Completed Phase 2

~240

Gemcitabine

2017

Completed Phase 3

~2070

Research blood draw

2022

Completed Phase 2

~240

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,937 Previous Clinical Trials

2,299,604 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,752 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,667 Previous Clinical Trials

40,926,068 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there potential risks for those taking pegylated arginine deiminase?

"Our team at Power judged pegylated arginine deiminase to have a safety rating of 2, owing to the Phase 2 nature of this trial and thus lack of evidence for its efficacy."

Answered by AI

How many participants have been taken into this clinical experiment?

"This clinical trial is currently not taking on participants. It was originally posted in May of 2018, and the last update happened in May 2022. For those seeking other studies, there are 780 trials for sarcoma and ewing that are looking for patients as well as 729 studies recruiting volunteers to test their response to pegylated arginine deiminase treatment."

Answered by AI

What maladies has pegylated arginine deiminase been shown to be efficacious in treating?

"Pegylated arginine deiminase has long been used to restrain the spread of neoplasms, and aid in managing metastatic bladder cancer, advance directives, and urinary tract issues."

Answered by AI

Are there any other studies that have been conducted to explore the effects of pegylated arginine deiminase?

"Presently, there are 246 Phase 3 trials and 729 clinical studies in total that pertain to pegylated arginine deiminase. Of these trails, many are centered around Woolloongabba, Queensland; however, there is a total of 42152 medical sites conducting research into this compound."

Answered by AI

In what number of hospitals is this investigation underway?

"This clinical trial is currently recruiting patients from 4 locations around the United States, which include New york City, Palo Alto and Saint Louis. Additionally, there are other sites to choose from that may be closer for those interested in participating."

Answered by AI

Can individuals still join this research project?

"Clinicaltrials.gov data reveals that the study, initially posted on May 9th 2018 and last modified on May 24th 2022, is no longer pursuing subjects. Nevertheless, there are presently 1,509 other trials seeking enrolment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ADI-PEG 20 in Combination With Gemcitabine and Docetaxel for the Treatment of Soft Tissue Sarcoma, Osteosarcoma, Ewing's Sarcoma, and Small Cell Lung Cancer

2018. "ADI-PEG 20 in Combination With Gemcitabine and Docetaxel for the Treatment of Soft Tissue Sarcoma, Osteosarcoma, Ewing's Sarcoma, and Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03449901.