Glucarpidase for Osteosarcoma

Recruiting in Palo Alto (17 mi)

+2 other locations

Lara Davis - Oregon Health & Science ...

Overseen byLara Davis, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: OHSU Knight Cancer Institute

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This early phase I trial studies how well glucarpidase works in reducing toxicity in patients with osteosarcoma receiving high dose methotrexate treatment. Glucarpidase may reduce the levels of methotrexate in patients' blood and lead to shorter hospitalizations and a reduction in toxicities.

Eligibility Criteria

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.

Inclusion Criteria

Platelet count 75,000/mm^3 (or >= 75 x 10^9/L)

Total serum bilirubin =< 2 x ULN

I am 40 or older and considered high-risk.

+10 more

Exclusion Criteria

Uncontrolled intercurrent illness, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent

Participants with a history of hypersensitivity to Escherichia (E.)coli-derived proteins

I have no other cancers, or they were treated and cured over 2 years ago.

+8 more

Participant Groups

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.

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.