The CATSINDO Trial - Study on New Treatment Approach for Newly Diagnosed Osteosarcoma
Sponsor: Wake Forest University Health Sciences
ClinicalTrials ID:NCT07560826
This study is exploring if children, teens, and young adults with newly diagnosed high-grade osteosarcoma can safely leave the hospital with slightly higher levels of methotrexate in their blood after receiving standard chemotherapy. Participants are 22 years old or younger and are receiving standard MAP chemotherapy as part of their cancer treatment.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The aim of this study is to find out if it is safe for young patients with newly diagnosed high-grade osteosarcoma to be discharged from the hospital with higher methotrexate levels in their blood after receiving high-dose methotrexate chemotherapy. The study will also explore if patient-derived tumor samples can be successfully created across different centers. Researchers will compare the safety and hospital stay length to past patient data who were discharged at lower methotrexate levels. Participants will receive standard chemotherapy, meet specific discharge criteria, be monitored for side effects, and may choose to provide tumor and blood samples for future research.
Description
This study is looking at whether it is safe for children, teens, and young adults with newly diagnosed high-grade osteosarcoma to leave the hospital with higher levels of methotrexate in their blood after receiving high-dose methotrexate as part of their standard MAP chemotherapy. Participants will be discharged once they meet specific criteria for methotrexate clearance, kidney function, and overall safety. The study will adjust methotrexate discharge levels based on observed side effects, starting at a level of 0.15 micromolar.
The study will also compare hospital stay lengths and costs with past data using traditional discharge criteria. Optional studies include creating patient-derived tumor samples and analyzing circulating tumor cells to study chemotherapy sensitivity and other future research. A separate review of past patients treated with high-dose methotrexate will help understand safety outcomes and methotrexate clearance patterns.
Eligibility Criteria
Inclusion Criteria
- Have localized or metastatic high-grade osteosarcoma.
- Be 22 years old or younger.
- Have a body surface area of at least 0.8 m2.
- Be receiving or planning to receive MAP chemotherapy with high-dose methotrexate at the standard dose.
- May be part of other clinical studies as long as they include MAP chemotherapy with the standard methotrexate dose.
- May receive other chemotherapy drugs that do not interfere with methotrexate clearance.
- Have adequate liver, kidney, and bone marrow function as determined by specific medical tests.
- Have adequate heart function as determined by standard medical imaging.
- Provide informed consent and assent if appropriate.
- Can enroll after starting MAP chemotherapy but before the second cycle.
- Be willing and able to follow all study procedures for the entire study duration.
Exclusion Criteria
- Female participants who are pregnant or breastfeeding.
- Sexually active participants who can have children and have not agreed to use effective birth control during the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of North Carolina at Chapel Hill | 27599 | Chapel Hill | North Carolina |
| Atrium Health Levine Children's Hospital | 28203 | Charlotte | North Carolina |
| Novant Health Hemby Children's Hospital | 28204 | Charlotte | North Carolina |
| Duke University Medical Center | 27710 | Durham | North Carolina |
| East Carolina University | 27834 | Greenville | North Carolina |
| Atrium Health Wake Forest Baptist | 27157 | Winston-Salem | North Carolina |
| Medical University of South Carolina | 29425 | Charleston | South Carolina |
| Prisma Health Midlands | 29203 | Columbia | South Carolina |
| Prisma Health Upstate | 29605 | Greenville | South Carolina |
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