The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age7-22
SponsorWake Forest University Health Sciences
About 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.
Eligibility criteria
Qualifiers
Suspected diagnosis of high-grade osteosarcoma based on clinical and radiographic findings.
Informed consent (and assent, if applicable) obtained, per institutional guidelines.
Participants must be ≤ 22 years of age at the time of consent.
Participants with localized or metastatic high-grade osteosarcoma.
Disqualifiers
Female participants who are pregnant and/or lactating and breast feeding their infant(s).
Sexually active participants of reproductive potential who have not agreed to use an effective contraceptive method for the duration of protocol therapy, at the discretion of the investigator.
Trial design
Treatments tested in this trial
- High-dose Methotrexate
Treatment groups
46 Participants
are divided into 1 treatment groupSponsors and collaborators
Wake Forest University Health Sciences
Lead sponsor
Alliance for Research and Innovations in Pediatric Oncology (ARISE) Cancer Consortium
Collaborator
Source ClinicalTrials.gov