The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma

NCT07560826 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: Pro00081644ARISE-CATSINDO
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Osteosarcoma in Children; Osteosarcoma in Adolescents and Young Adults

Keywords

Osteosarcoma; CATSINDO; Organoids; Interventional

Outcome Measures

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

  Within 7-days post-discharge of methotrexate visit

Secondary Outcomes (2)

• Length of Stay (LOS)

  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)

• Patient Cost Per Visit

  Approximately 30 weeks per participant from first week of treatment

Study Arms (1)

Standard-of-Care MAP Chemotherapy with Threshold-Adjusted HD-MTX Discharge

EXPERIMENTAL

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.

Drug: High-dose Methotrexate

Interventions

High-dose Methotrexate DRUG

High-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.

Standard-of-Care MAP Chemotherapy with Threshold-Adjusted HD-MTX Discharge

Eligibility Criteria

• Age: 7 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants with localized or metastatic high-grade osteosarcoma.
• Participants must be ≤ 22 years of age at the time of consent.
• Participants must have a body surface area of greater than or equal to 0.8 m2.
• Participants receiving or planning to receive induction/neoadjuvant MAP chemotherapy with HD-MTX given at the standard dose of 12 gm/m2 (maximum 20 gm).
• NOTE: Participants may be participating on other clinical studies such as the COG trial AOST2032 or any other clinical trial as long as their treatment includes MAP chemotherapy with the standard HD-MTX dose of 12 gm/m2 (maximum 20 gm).
• Participants may receive other chemotherapy agents in their treatment provided that drug(s) are not known to interfere with HD-MTX clearance when given concurrently. Medications known to interfere with HD-MTX clearance are listed in Appendix A.
• Participants must meet minimum organ function requirements to receive HD-MTX:
• Adequate liver function defined as: total bilirubin ≤ 1.5x upper limit of normal (ULN) for age at the time of consent and alanine aminotransferase (ALT/SGPT) ≤ 135 U/L for age at the time of consent.
• Adequate renal function defined as: a serum creatinine based on age/gender OR - a 24-hour urine Creatinine clearance ≥ 70 mL/min/1.73 m2, OR - an estimated glomerular filtration rate (GFR) of greater than or equal to 70 mL/min/1.73 m2 for age at the time of consent.
• Adequate bone marrow function defined as: peripheral absolute neutrophil count (ANC) ≥ 1000/µL, platelet count ≥ 100,000/µL (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment), and hemoglobin ≥ 8.0 g/dL (transfusion independent, defined as not receiving red blood cell transfusions within a 7-day period prior to enrollment)
• Adequate cardiac function, defined as a left ventricular ejection fraction (LVEF) ≥ 50%, assessed per institutional standard of care using non-invasive imaging modalities such as a Multi-Gated Acquisition (MUGA) scan or echocardiogram (echo).
• NOTE: Cardiac function assessment will be performed as part of routine clinical care. No additional imaging or procedures will be mandated by the research protocol.
• Informed consent, and assent when appropriate, must be obtained, per institutional guidelines.
• Participants can enroll after initiation of induction MAP chemotherapy so long as they are enrolled prior to the second cycle of chemotherapy (prior to week 6 cisplatin and doxorubicin).
• Participants must be willing and able to comply with all study procedures for the entire length of the study.

You may not qualify if:

• Female participants who are pregnant and/or lactating and breast feeding their infant(s).
• NOTE: Pregnancy testing will follow institutional standard of care practice and is not mandated by the protocol.
• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Alliance for Research and Innovations in Pediatric Oncology (ARISE) Cancer Consortium: collaborator

Study Sites (8)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Novant Health Hemby Children's Hospital

Charlotte, North Carolina, 28204, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Prisma Health Midlands

Columbia, South Carolina, 29203, United States

Location

Prisma Health Upstate

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Osteosarcoma

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Thomas Russell, MD

  Alliance for Research and Innovations in Pediatric Oncology (ARISE) Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Neagle

CONTACT

980-442-2303; heather.neagle@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 1, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)