An Early Phase 1 interventional study of Glucarpidase and Quality-of-Life Assessment in Osteosarcoma, sponsored by OHSU Knight Cancer Institute. Completed at 3 sites in United States. Open to participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by OHSU Knight Cancer Institute · Early Phase 1, Interventional, and Treatment
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.
PRIMARY OBJECTIVE:
I. To determine the rate of completion of 4 planned high dose methotrexate (HDMTX) doses when glucarpidase is administered after each dose.
SECONDARY OBJECTIVES:
I. To assess the length of hospital stay (LOS) associated with methotrexate (MTX) clearance following administration of glucarpidase 24 hours after HDMTX.
II. To assess the LOS associated with all causes following administration of glucarpidase 24 hours after HDMTX.
III. To assess the impact of glucarpidase administration on HDMTX efficacy. IV. To assess the safety and tolerability of 4 doses of HDMTX administered with glucarpidase in an adult osteosarcoma population.
V. To assess the efficacy of glucarpidase flat dose of 1,000 units.
OUTLINE:
Patients receive standard of care HDMTX intravenously (IV) over 4 hours on day 1 of weeks 4, 5, 9, and 10. After 24 and 48 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. Additionally, patients undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed up for 32 weeks.
437 studies on the registry are indexed under Osteosarcoma; 116 are open to participants now.
This study's enrollment of 11 is below the median of 42 across 325 interventional studies indexed under Osteosarcoma.
Browse Osteosarcoma studies →OHSU Knight Cancer Institute is the lead sponsor of 242 studies on the registry; 45 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 15 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
All races and ethnic groups will be eligible
Exclusion Criteria:
Malignant disease, other than those being treated in this study. Exceptions to this exclusion include the following:
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.
Drug: Glucarpidase · Other: Quality-of-Life Assessment
Given IV
Also known as: Acetylaspartylglutamate Dipeptidase, Carboxypeptidase G2, carboxypeptidase-G2, CPDG2, CPG2, Poly(gamma-glutamic Acid) Endohydrolase, Pteroylpolygammaglutamyl Hydrolase, Voraxaze
Ancillary studies
Also known as: Quality of Life Assessment
Proportion of subjects completing 4 planned doses of high dose methotrexate (HDMTX)
Will be estimated with an exact 95% confidence interval (CI).
Time frame: Time from first dose of HDMTX to time of last dose of HDMTX (week 10)
Length of hospital stay (LOS) for methotrexate (MTX) clearance
Time frame: Time of start of MTX administration to time of MTX =< 0.1uM sample collection for each planned MTX infusion (up to 15 days)
LOS for all causes (excluding MTX-related AEs)
Time frame: Date of admission for each planned MTX infusion to date of discharge for each planned MTX infusion (up to 15 days)
Length of hospital stay (LOS) for methotrexate (MTX)-related adverse events (AEs)
Time frame: Date of admission for each planned MTX infusion to date of discharge for each planned MTX infusion (up to 15 days)
Percent treatment effect at resection
Defined as an admixture of degenerating wispy osteoid matrix with empty lacunae, necrotic ghost cells, and edematous stroma with loose fibrous tissue. Dense fibrosis or hyalinization or sheets of sclerotic acellular osteoid may also be present. These features are quantified by estimating the percentage of each parameter in each tumor slide and calculating the mean based on the total number of tumor slides examined. The percentage of tumor necrosis or treatment effect will be recorded from each participant's surgical pathology report.
Time frame: From start of surgery until end of surgery
Incidence of glucarpidase hypersensitivity
Will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Will be determined for participants that received at least 1 dose of glucarpidase following an HDMTX infusion. The 95% CI will be reported with the point estimate of toxicity rate.
Time frame: From first dose of glucarpidase until 30 days after last dose of glucarpidase
Incidence of glucarpidase neutralizing antibodies
Will be determined for participants that received at least 1 dose of glucarpidase following an HDMTX infusion. The 95% CI will be reported with the point estimate of toxicity rate.
Time frame: From first dose of glucarpidase to 30 days after last dose of glucarpidase
Incidence and severity of MTX-related toxicities
Will be assessed according to CTCAE v 5.0. Will be determined for participants that received at least 1 dose of glucarpidase following an HDMTX infusion. The 95% CI will be reported with the point estimate of toxicity rate.
Time frame: From start of first planned MTX infusion to 30 days after last dose of MTX
Incidence and severity of glucarpidase toxicities
Will be assessed according to CTCAE v 5.0. Will be determined for participants that received at least 1 dose of glucarpidase following an HDMTX infusion. The 95% CI will be reported with the point estimate of toxicity rate.
Time frame: From first dose of glucarpidase to 30 days after last dose of glucarpidase
MTX and DAMPA serum concentration (umol/L) at 4, 24, 24.5, 36, 48 and every 24 hours after the start of MTX infusion
Time frame: From start of each planned MTX infusion to time when MTX =< 0.1 uM (for each planned MTX infusion) (up to 15 days)
Proportion of glucarpidase doses (flat dose) that result in MTX serum concentration reduction of >= 97% from hour 24 to hour 24.5
Will be presented along with 95% confidence intervals. Summary statistics will be reported on the efficacy analysis set with sub-analyses stratified by glucarpidase dose.
Time frame: From first dose of glucarpidase to end of study treatment (week 10)
Proportion of glucarpidase doses (flat dose) that result in 48 hour serum MTX level < 1 uM
Will be presented along with 95% confidence intervals. Summary statistics will be reported on the efficacy analysis set with sub-analyses stratified by glucarpidase dose.
Time frame: From first dose of glucarpidase to end of study treatment (week 10)
Plan to share: Undecided
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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OHSU Knight Cancer Institute