The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
High-dose Methotrexate
DrugHigh-dose methotrexate (HD-MTX) is administered intravenously at a dose of 12 g/m² (maximum dose 20 g) over 4 hours as part of standard-of-care MAP chemotherapy for participants with newly diagnosed high-grade osteosarcoma. HD-MTX is delivered with standard supportive care measures, including alkalinized intravenous hydration, serial serum methotrexate level monitoring, and leucovorin rescue beginning 24 hours after methotrexate initiation and continued until discharge criteria are met. Treatment is administered according to institutional standards throughout neoadjuvant/induction and adjuvant/consolidation therapy.
Treatment groups
46 Participants
are divided into 1 treatment groupGroup A: Standard-of-Care MAP Chemotherapy with Threshold-Adjusted HD-MTX DischargeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Dose Limiting Toxicity (DLT)
A binary response for dose-limiting toxicity following MTX visit discharge defined as rehospitalization due to acute toxicity or serious adverse event of special interest
Time frame
Within 7-days post-discharge of methotrexate visitSecondary outcomes
1
Length of Stay (LOS)
Length of hospital stay measured in hours from time of admission to time of discharge for each HD-MTX inpatient cycle
Time frame
From time of admission to time of discharge in hours for each HD-MTX inpatient cycle, assessed across [up to] 12 cycles per participant, through completion of HD-MTX therapy (up to approximately 30 weeks per participant from first week of treatment)2
Patient Cost Per Visit
Total estimated cost associated with each HD-MTX inpatient cycle, based on hospital billing charges and nights of stay
Time frame
Approximately 30 weeks per participant from first week of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wake Forest University Health Sciences
Lead sponsor
Alliance for Research and Innovations in Pediatric Oncology (ARISE) Cancer Consortium
Collaborator
Source ClinicalTrials.gov