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Glucarpidase for Osteosarcoma

Phase < 1
Recruiting
Led By Lara E Davis
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A minimum of 6 individuals aged >= 40 years will be enrolled. These participants are considered high-risk
Eastern Cooperative Oncology Group (ECOG) performance score 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of each planned mtx infusion to time when mtx =< 0.1 um (for each planned mtx infusion) (up to 15 days)
Awards & highlights

Study Summary

This trial is testing how well glucarpidase reduces toxicity in patients with osteosarcoma receiving high doses of methotrexate.

Who is the study for?
This trial is for people with osteosarcoma who haven't had high-dose methotrexate before. They must be in good enough health to handle the treatment, have a certain level of blood cells and organ function, and agree to use birth control. It's not for those with significant liver disease, HIV, or other active cancers (with some exceptions), or women who are pregnant/breastfeeding.Check my eligibility
What is being tested?
The trial tests glucarpidase's ability to reduce toxicity from high-dose methotrexate in osteosarcoma patients. The goal is to see if it can lower methotrexate levels in the blood, potentially leading to shorter hospital stays and fewer side effects.See study design
What are the potential side effects?
Glucarpidase may cause allergic reactions due to its E.coli origin. Side effects could include issues related to enzyme activity such as nausea or changes in blood chemistry but specific side effect profiles will be monitored during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 40 or older and considered high-risk.
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I can take care of myself and am up and about more than half of the day.
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I have a new diagnosis of osteosarcoma and haven't started treatment, except possibly doxorubicin/cisplatin.
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I agree to use birth control during and for four months after my treatment.
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My treatment plan for osteosarcoma includes high-dose methotrexate.
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My kidney function is within the normal range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of surgery until end of surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of surgery until end of surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of subjects completing 4 planned doses of high dose methotrexate (HDMTX)
Secondary outcome measures
Incidence and severity of MTX-related toxicities
Incidence and severity of glucarpidase toxicities
Incidence of glucarpidase hypersensitivity
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (glucarpidase)Experimental Treatment2 Interventions
Patients receive standard of care HDMTX IV over 4 hours on day 1 of weeks 4, 5, 9, and 10. After 24 hours after the start of each HDMTX infusion, patients also receive glucarpidase IV over 5 minutes in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glucarpidase
2008
Completed Phase 3
~50

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor
227 Previous Clinical Trials
2,090,591 Total Patients Enrolled
1 Trials studying Osteosarcoma
54 Patients Enrolled for Osteosarcoma
BTG International Inc.OTHER
42 Previous Clinical Trials
3,074 Total Patients Enrolled
2 Trials studying Osteosarcoma
27 Patients Enrolled for Osteosarcoma
Oregon Health and Science UniversityOTHER
968 Previous Clinical Trials
6,845,774 Total Patients Enrolled
1 Trials studying Osteosarcoma
54 Patients Enrolled for Osteosarcoma

Media Library

Glucarpidase Clinical Trial Eligibility Overview. Trial Name: NCT03960177 — Phase < 1
Osteosarcoma Research Study Groups: Treatment (glucarpidase)
Osteosarcoma Clinical Trial 2023: Glucarpidase Highlights & Side Effects. Trial Name: NCT03960177 — Phase < 1
Glucarpidase 2023 Treatment Timeline for Medical Study. Trial Name: NCT03960177 — Phase < 1

Frequently Asked Questions

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

What therapeutic applications is Glucarpidase typically employed for?

"Glucarpidase is a form of therapy used to supplement amino acids, reduce any impairment in renal function, and manage methotrexate toxicity."

Answered by AI

Is enrollment for this experiment available at the moment?

"Affirmative. The clinical trial is actively recruiting based on the information available on clinicaltrials.gov; it was initially posted in March of 2019 and last updated in June 2022, with 12 participants to be recruited from 5 different locations."

Answered by AI

Are there any documented analyses of Glucarpidase's efficacy?

"Currently, 10 clinical trials are investigating the efficacy of Glucarpidase. Of those 10 studies, one is in its final phase 3 trial. Although most experiments for this drug occur at locations within New york City, there exist 24 sites running trials across the US."

Answered by AI

How many study participants are being monitored for this clinical investigation?

"This trial necessitates the recruitment of 12 eligible individuals. Mayo Clinic in Florida (Jacksonville) and University of Pennsylvania/Abramson Cancer Center (Philadelphia) are two approved sites that can accommodate participants."

Answered by AI

To what extent is this research being conducted within the borders of our state?

"Mayo Clinic locations in Jacksonville, Florida and Rochester, Minnesota are hosting enrolment for this trial. Additionally, the University of Pennsylvania/Abramson Cancer Center in Philadelphia is also involved along with 5 additional sites."

Answered by AI
~2 spots leftby Jun 2025