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Glucarpidase for Osteosarcoma
Study Summary
This trial is testing how well glucarpidase reduces toxicity in patients with osteosarcoma receiving high doses of methotrexate.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have no other cancers, or they were treated and cured over 2 years ago.I have a significant liver condition or HIV but am eligible if my HCV has been cured.I am 40 or older and considered high-risk.I can take care of myself and am up and about more than half of the day.You have had severe allergic reactions to the study medication or any of its ingredients.I have a new diagnosis of osteosarcoma and haven't started treatment, except possibly doxorubicin/cisplatin.I agree to use birth control during and for four months after my treatment.My treatment plan for osteosarcoma includes high-dose methotrexate.I have been treated with glucarpidase before.I have a large fluid collection in my chest or abdomen.My condition is worsening quickly and I can't undergo high-dose methotrexate treatment.I have been treated with high-dose methotrexate.I cannot stop taking medications that affect methotrexate.My kidney function is within the normal range.
- Group 1: Treatment (glucarpidase)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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