New enzyme therapy may shorten hospital stays for bone cancer patients
NCT ID NCT03960177
First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times
Summary
This early-phase study tests whether glucarpidase can lower the toxic side effects of high-dose methotrexate in adults with osteosarcoma, a type of bone cancer. The goal is to help patients complete their planned chemotherapy doses and spend less time in the hospital. About 12 participants will receive glucarpidase alongside their standard treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
11 people
The number who actually took part.
- Started
-
Mar 2019
- Finished
-
Dec 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
25 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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). * 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. Exclusion Criteria: * 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. * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Osteosarcoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
-
OHSU Knight Cancer Institute
Portland, Oregon, 97239, United States
-
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A vast data bank could unlock secrets of bone and muscle diseases
- Can an immune booster outsmart High-Risk bone cancer?
- Can a new tracer light up bone cancer tumors?
- Can a Two-Drug combo beat tough childhood cancers?
- A simple blood test may reveal hidden infertility risk in young cancer survivors
- Can a targeted pill stall advanced sarcomas?