High-dose Methotrexate for Bone Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this study is to learn whether children, adolescents, and young adults with newly diagnosed high-grade osteosarcoma can be safely discharged from the hospital at slightly higher methotrexate blood levels after receiving standard high-dose methotrexate chemotherapy. Participants are 22 years old or younger and are receiving standard MAP (high-dose methotrexate with doxorubicin and cisplatin) chemotherapy as part of their routine cancer treatment.
The main questions this study aims to answer are:
* Is hospital discharge at higher methotrexate levels safe, based on side effects or hospital re-admission within 7 days?
* Can patient-derived osteosarcoma tumor organoids be successfully generated across multiple centers?
Researchers will compare safety outcomes and hospital length of stay to historical patient data discharged at lower methotrexate levels.
Participants will receive standard chemotherapy, meet study-defined discharge criteria, be monitored for side effects, and have the option to provide tumor and blood samples for future research.
Who Is on the Research Team?
Thomas Russell, MD
Principal Investigator
Alliance for Research and Innovations in Pediatric Oncology (ARISE) Cancer Consortium
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard MAP chemotherapy, including high-dose methotrexate, with hospital discharge based on serum methotrexate threshold levels
Follow-up
Participants are monitored for safety and effectiveness after treatment, including incidence of dose-limiting toxicity within 7 days post-discharge
Optional Correlative Studies
Participants may provide tumor and blood samples for future research, including patient-derived osteosarcoma tumor organoids and circulating tumor cells
What Are the Treatments Tested in This Trial?
Interventions
- High-dose Methotrexate
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants with newly diagnosed high-grade osteosarcoma receive standard-of-care MAP chemotherapy, including high-dose methotrexate (HD-MTX), with hospital discharge based on serum methotrexate threshold levels (ranging from ≤0.10 µM to ≤0.20 µM) and renal function criteria to evaluate the safety of earlier discharge. Threshold levels are not randomized and are evaluated sequentially over the course of the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
Alliance for Research and Innovations in Pediatric Oncology (ARISE) Cancer Consortium
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.