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

23 aprile 2026 aggiornato da: Wake Forest University Health Sciences

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This Phase II, multi-institutional study evaluates the safety of hospital discharge at higher serum methotrexate (MTX) levels in children, adolescents, and young adults with newly diagnosed high-grade osteosarcoma receiving standard-of-care high-dose methotrexate (HD-MTX) as part of MAP chemotherapy.

Participants are discharged once they meet the pre-defined MTX clearance, kidney function, and clinical safety criteria. Methotrexate discharge thresholds are evaluated using an adaptive Bayesian threshold-finding design, starting at a serum MTX level of less than or equal to 0.15 micromolar, with possible escalation or de-escalation based on observed toxicity.

Secondary objectives include comparison of hospital length of stay and estimated inpatient costs with historical controls using traditional discharge criteria. Optional correlative studies include patient-derived osteosarcoma tumor organoids and circulating tumor cells to evaluate chemotherapy sensitivity and other future research. A separate retrospective chart review of prior patients treated with HD-MTX is included to understand safety outcomes and MTX clearance patterns.

Tipo di studio

Interventistico

Iscrizione (Stimato)

46

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27599
        • University of North Carolina at Chapel Hill
        • Contatto:
        • Investigatore principale:
          • Ian Davis, MD, PhD
      • Charlotte, North Carolina, Stati Uniti, 28204
        • Novant Health Hemby Children's Hospital
        • Investigatore principale:
          • Jessica Bell, MD
        • Contatto:
      • Durham, North Carolina, Stati Uniti, 27710
        • Duke University Medical Center
        • Investigatore principale:
          • Jessica Sun, MD
        • Contatto:
      • Greenville, North Carolina, Stati Uniti, 27834
        • East Carolina University
        • Contatto:
        • Investigatore principale:
          • Andrea Whitfield, DO
      • Winston-Salem, North Carolina, Stati Uniti, 27157
        • Atrium Health Wake Forest Baptist
        • Investigatore principale:
          • Sarah Supples, MD
        • Contatto:
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29425
        • Medical University of South Carolina
        • Investigatore principale:
          • Jacqueline Kraveka, DO
        • Contatto:
      • Columbia, South Carolina, Stati Uniti, 29203
        • Prisma Health Midlands
        • Contatto:
        • Investigatore principale:
          • Chandni Dargan, MD
      • Greenville, South Carolina, Stati Uniti, 29605
        • Prisma Health Upstate
        • Investigatore principale:
          • Chandni Dargan, MD
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

Pre-Enrollment Criteria:

  1. Suspected diagnosis of high-grade osteosarcoma based on clinical and radiographic findings.
  2. Informed consent (and assent, if applicable) obtained, per institutional guidelines.
  3. Participants must be ≤ 22 years of age at the time of consent.

Inclusion Criteria:

  1. Participants with localized or metastatic high-grade osteosarcoma.
  2. Participants must be ≤ 22 years of age at the time of consent.
  3. Participants must have a body surface area of greater than or equal to 0.8 m2.

  4. 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).

  5. 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.

  6. 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)

  7. 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.

  8. Informed consent, and assent when appropriate, must be obtained, per institutional guidelines.
  9. 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).
  10. Participants must be willing and able to comply with all study procedures for the entire length of the study.

Exclusion Criteria:

  1. 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.

  2. 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Standard-of-Care MAP Chemotherapy with Threshold-Adjusted HD-MTX Discharge
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.
Droga: High-dose Methotrexate
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Dose Limiting Toxicity (DLT)
Lasso di tempo: Within 7-days post-discharge of methotrexate visit
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Length of Stay (LOS)
Lasso di tempo: 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)
Length of hospital stay measured in hours from time of admission to time of discharge for each HD-MTX inpatient cycle
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
Lasso di tempo: Approximately 30 weeks per participant from first week of treatment
Total estimated cost associated with each HD-MTX inpatient cycle, based on hospital billing charges and nights of stay
Approximately 30 weeks per participant from first week of treatment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Wake Forest University Health Sciences

Collaboratori

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

Investigatori

  • Investigatore principale: Thomas Russell, MD, Alliance for Research and Innovations in Pediatric Oncology (ARISE) Cancer Consortium

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 dicembre 2028

Completamento dello studio (Stimato)

1 dicembre 2028

Date di iscrizione allo studio

Primo inviato

16 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

23 aprile 2026

Primo Inserito (Effettivo)

1 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Pro00081644 (Advarra IRB)
  • ARISE-CATSINDO (Altro identificatore: Alliance for Research and Innovations in Pediatric Oncology (ARISE) Cancer Consortium)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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