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

23. April 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

46

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • North Carolina
      • Chapel Hill, North Carolina, Vereinigte Staaten, 27599
        • University of North Carolina At Chapel Hill
        • Kontakt:
        • Hauptermittler:
          • Ian Davis, MD, PhD
      • Charlotte, North Carolina, Vereinigte Staaten, 28204
        • Novant Health Hemby Children's Hospital
        • Hauptermittler:
          • Jessica Bell, MD
        • Kontakt:
      • Durham, North Carolina, Vereinigte Staaten, 27710
        • Duke University Medical Center
        • Hauptermittler:
          • Jessica Sun, MD
        • Kontakt:
      • Greenville, North Carolina, Vereinigte Staaten, 27834
        • East Carolina University
        • Kontakt:
        • Hauptermittler:
          • Andrea Whitfield, DO
      • Winston-Salem, North Carolina, Vereinigte Staaten, 27157
    • South Carolina
      • Charleston, South Carolina, Vereinigte Staaten, 29425
        • Medical University of South Carolina
        • Hauptermittler:
          • Jacqueline Kraveka, DO
        • Kontakt:
      • Columbia, South Carolina, Vereinigte Staaten, 29203
        • Prisma Health Midlands
        • Kontakt:
        • Hauptermittler:
          • Chandni Dargan, MD
      • Greenville, South Carolina, Vereinigte Staaten, 29605
        • Prisma Health Upstate
        • Hauptermittler:
          • Chandni Dargan, MD
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of Dose Limiting Toxicity (DLT)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Length of Stay (LOS)
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Wake Forest University Health Sciences

Mitarbeiter

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

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2028

Studienabschluss (Geschätzt)

1. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

16. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. April 2026

Zuerst gepostet (Tatsächlich)

1. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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