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Glucarpidase for Osteosarcoma

Phase < 1

Waitlist Available

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

Eastern Cooperative Oncology Group (ECOG) performance score 0-2

Participants must have a recommended treatment plan for their osteosarcoma that includes planned MTX treatment at 8-12 g/m^2

Must not have

Previous treatment with glucarpidase

Participants with large pleural or ascitic fluid collection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose of glucarpidase to 30 days after last dose of glucarpidase

Awards & highlights

No Placebo-Only Group

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.

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.

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 can take care of myself and am up and about more than half of the day.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with glucarpidase before.

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I have a large fluid collection in my chest or abdomen.

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My condition is worsening quickly and I can't undergo high-dose methotrexate treatment.

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I have been treated with high-dose methotrexate.

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I cannot stop taking medications that affect methotrexate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of surgery until end of surgery

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

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

Primary study objectives

Proportion of subjects completing 4 planned doses of high dose methotrexate (HDMTX)

Secondary study objectives

Incidence and severity of MTX-related toxicities

Incidence and severity of glucarpidase toxicities

Incidence of glucarpidase hypersensitivity

+4 more

Awards & Highlights

No Placebo-Only Group

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

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

0 / 8Eligibility criteria met