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OsteosarcomaEarly Phase 1NCT03960177

Glucarpidase After High-Dose Methotrexate in Patients With Osteosarcoma

A Early Phase 1 study testing Glucarpidase and Quality-of-Life Assessment in people with Osteosarcoma, run by OHSU Knight Cancer Institute at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 25 years and older
Conditions the study is for
Osteosarcoma
What is being tested?
Glucarpidase and Quality-of-Life Assessment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
3 sitesUnited States
Study dates
27 Mar 2019to 31 Dec 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All races and ethnic groups will be eligible
  • 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.
  • Participants must have pathologically confirmed diagnosis of osteosarcoma. Participants must be newly diagnosed and previously untreated, although initiation of doxorubicin/cisplatin prior to enrollment is permitted.
  • Participants must have a recommended treatment plan for their osteosarcoma that includes planned MTX treatment at 8-12 g/m^2.
  • Absolute neutrophil count (ANC) >= 1,000/mm^3 (or >= 1.0 x 10^9/L).
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  • Platelet count 75,000/mm^3 (or >= 75 x 10^9/L).
  • Hemoglobin >= 8 g/dL.
  • Serum creatinine =< 1.5 x the upper limit of normal (ULN), or glomerular filtration rate (GFR) >= 60 ml/min/1.73 m^2 as calculated by the Modification of Diet in Renal Disease (MDRD) formula.
  • Total serum bilirubin =< 2 x ULN.
  • Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) =< 2.5 x ULN.
  • Participants must be willing to use appropriate contraception for the duration of study treatment and four months after completing HDMTX therapy.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Malignant disease, other than those being treated in this study. Exceptions to this exclusion include the following:
  • Malignancies that were treated curatively and have not recurred within 2 years after completion of treatment;
  • Completely resected basal cell and squamous cell skin cancers;
  • Any malignancy considered to be indolent and that has never required therapy;
  • Completely resected carcinoma in situ of any type.
  • Participants with rapidly progressive disease or organ dysfunction that would prevent them from receiving planned HDMTX treatment regimen.
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  • Previous MTX treatment at doses >= 3 g/m^2.
  • Previous treatment with glucarpidase.
  • Known clinically significant liver disease defined as ongoing drug-induced liver injury, chronic active hepatitis C (HCV), chronic active hepatitis B (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, portal hypertension, or history of autoimmune hepatitis. Patients who have completed curative therapy for HCV are eligible. Patients with known history of human immunodeficiency virus (HIV) infection are eligible.
  • Participants with a history of hypersensitivity reactions to study agent or its excipients.
  • Participants with a history of hypersensitivity to Escherichia (E.)coli-derived proteins.
  • Participants with large pleural or ascitic fluid collection.
  • Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
  • 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.
  • Unable or unwilling to discontinue use of agents that interact significantly with methotrexate metabolism or excretion.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: An Open-Label, Multi-Institutional Pilot Study to Assess the Use of Glucarpidase in Adult Patients With Osteosarcoma Receiving High-Dose Methotrexate

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the rate of completion of 4 planned high dose methotrexate (HDMTX) doses when glucarpidase is administered after each dose.

SECONDARY OBJECTIVES:

  1. 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.

  1. 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.

Conditions
Osteosarcoma
Being tested
Glucarpidase, Quality-of-Life Assessment
Medical subject headings
Osteosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GlucarpidaseDrug

    Also called Acetylaspartylglutamate Dipeptidase, Carboxypeptidase G2, carboxypeptidase-G2, CPDG2

    Given IV

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

Study groups in NCT03960177
Study groupRoleWhat they receive
Treatment (glucarpidase)ExperimentalPatients 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.
Receives: Drug: Glucarpidase; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Will be estimated with an exact 95% confidence interval (CI).

    Measured: Time from first dose of HDMTX to time of last dose of HDMTX (week 10)

Secondary outcomes (11)

  1. Length of hospital stay (LOS) for methotrexate (MTX) clearance

    Measured: Time of start of MTX administration to time of MTX =< 0.1uM sample collection for each planned MTX infusion (up to 15 days)

  2. LOS for all causes (excluding MTX-related AEs)

    Measured: Date of admission for each planned MTX infusion to date of discharge for each planned MTX infusion (up to 15 days)

  3. Length of hospital stay (LOS) for methotrexate (MTX)-related adverse events (AEs)

    Measured: Date of admission for each planned MTX infusion to date of discharge for each planned MTX infusion (up to 15 days)

  4. 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.

    Measured: From start of surgery until end of surgery

  5. 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.

    Measured: From first dose of glucarpidase until 30 days after last dose of glucarpidase

  6. 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.

    Measured: From first dose of glucarpidase to 30 days after last dose of glucarpidase

  7. 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.

    Measured: From start of first planned MTX infusion to 30 days after last dose of MTX

  8. 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.

    Measured: From first dose of glucarpidase to 30 days after last dose of glucarpidase

  9. MTX and DAMPA serum concentration (umol/L) at 4, 24, 24.5, 36, 48 and every 24 hours after the start of MTX infusion

    Measured: From start of each planned MTX infusion to time when MTX =< 0.1 uM (for each planned MTX infusion) (up to 15 days)

  10. 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.

    Measured: From first dose of glucarpidase to end of study treatment (week 10)

  11. 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.

    Measured: From first dose of glucarpidase to end of study treatment (week 10)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2019
  2. Study start27 Mar 2019
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03960177
Sponsor's protocol ID
STUDY00019380
Other IDs
NCI-2019-02257, STUDY00019380
Status last verified
Jul 2026
First submitted
13 May 2019
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Glucarpidase and Quality-of-Life Assessment in people with Osteosarcoma, run by OHSU Knight Cancer Institute at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects completing 4 planned doses of high dose methotrexate (HDMTX) (time frame: Time from first dose of HDMTX to time of last dose of HDMTX (week 10)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03960177.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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