Connexion
M'inscrire

Votre recherche

Filtres

Project précédent
Projet suivant
Nous verifions auprès de chaque centre si des nouvelles informations sont disponibles

MCC-20339

Evolutionary therapy for rhabdomyosarcoma
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT04388839
Soft Tissue Cancer
Skeletal Muscle Tissue Cancer
Sarcoma
Source :Importé depuis le centre
rhabdomyosarcome
chimiothérapie
métastatique
FISH
PCR
PAX/FOXO1
FFPE
biopsie
TEP
cyclophosphamide
contraception
assentiment
infection
arythmie
psychiatrique
Mots clés générés par intelligence artificielle
Recrutement fermé
Dernière modification : 2025/11/25
Type de recherche

Interventionnel

Médicament expérimental

PHASE2


Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Sexe(s) des participants

ALL

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

Inclusion Criteria:

* Participants must have a new histologic diagnosis of rhabdomyosarcoma
* Participants must have FISH, PCR or other molecular confirmation of PAX/FOXO1 fusion per institutional standards
* Participants must have sufficient tissue (up to 10 unstained FFPE) for correlative testing
* All participants must have distant metastatic disease; either biopsy positive or PET avid extranodal or distant nodal lesions determined by the investigator to be metastatic disease. Patients with a single distant metastatic site that has been excised prior to study entry are eligible
* No prior systemic chemotherapy
* Participants enrolled to Arm B, maintenance, must be able to take oral cyclophosphamide. Note: enteral administration of cyclophosphamide is allowable.
* Males and females of reproductive potential may not participate unless they have agreed to the use of, at minimum, two methods of contraception during and after treatment or abstinence.
* Women of childbearing potential should adhere to contraception for a period of 4 months after completion of systematic chemotherapy administration
* Men who are sexually active with women of child bearing potential should adhere to contraception for a period of 4 months after completion of systematic chemotherapy administration
* All patients and/or their parents or legal guardians must have the ability to understand and the willingness to sign a written informed consent or assent document.

Exclusion Criteria:

* Participants with regional lymph nodes as the only site of disease are not eligible. Distant nodal sites alone are eligible
* Participants who are receiving any other investigational agents for rhabdomyosarcoma are ineligible
* Participants must not be receiving any additional medicines being given for the specific purpose of treating cancer. Alternative medications including, but not limited to cannabis based products would not be a reason for exclusion
* Participants are ineligible if they have uncontrolled intercurrent illness including, but not limited to:

* ongoing or active infection not expected to resolve with current antibiotic plan
* cardiac arrhythmia
* psychiatric illness/social situations that would limit compliance with study requirements
* Patients who are pregnant or breastfeeding are not eligible because there is no available information regarding human fetal or teratogenic toxicities. Females of childbearing potential must have a negative serum or urine pregnancy test within 24 hours of starting protocol therapy.
* Participants who are considered unable to comply with the safety monitoring requirements of the study are not eligible

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
Arm A - First Strike Participants will receive 42 weeks of conventional doses of vinorelbine, actinomycin D and cyclophosphamide Donnée non disponible
  • Inconnu
  • Arm B - Second Strike - Maintenance Participants will receive conventional doses of Vincristine/Actinomycin D/Cyclophosphamide (VAC) until complete response (CR) for 12-42 weeks and then switch to up to 2 years of vinorelbine/oral cyclophoshamide Donnée non disponible
  • Inconnu
  • Arm C - Adaptive Therapy Therapy with VAC that starts and stops based on response, adaptive timing of therapy, with a prolonged time to progression rather than complete remission goal Donnée non disponible
  • Inconnu
  • Arm - D Conventional Therapy Participants will receive a chemotherapy combination based on published trials. An example would be 42 weeks of VAC but may also include irinotecan, doxorubicin, ifosfamide, etoposide. Donnée non disponible
  • Inconnu
  • Arm A - First Strike
    État du recrutement
    unknown
    Arm B - Second Strike - Maintenance
    État du recrutement
    unknown
    Arm C - Adaptive Therapy
    État du recrutement
    unknown
    Arm - D Conventional Therapy
    État du recrutement
    unknown
    Données à jour depuis : 25 novembre 2025

    Description de l'étude

    Résumé de l'étude

    This clinical trial will evaluate 4 different strategies of chemotherapy schedules in newly diagnosed participants with metastatic Fusion Positive (alveolar) Rhabdomyosarcoma. The participant and their physician will choose from: Arm A) a first strike therapy, Arm B) a first strike-second strike (maintenance) therapy, Arm C) an adaptively timed therapy, and Arm D) conventional chemotherapy.

    Source : Importé depuis le centre

    Sites

    Centres participants

      10 affichés sur 18 centres
    • CAROLINAS MEDICAL CENTER, LEVINE CANCER INSTITUTE

      Charlotte

      NORTH CAROLINA, UNITED STATES

      Recrutement local
      État du recrutement: FERMÉ
    • CHILDREN'S HOSPITAL OF COLORADO

      Aurora

      COLORADO, UNITED STATES

      Recrutement local
      État du recrutement: FERMÉ
    • CONNECTICUT CHILDREN'S MEDICAL CENTER

      Hartford

      CONNECTICUT, UNITED STATES

      Recrutement local
      État du recrutement: FERMÉ
    • DUKE CHILDREN'S HOSPITAL

      Durham

      NORTH CAROLINA, UNITED STATES

      Recrutement local
      État du recrutement: FERMÉ
    • JOHNS HOPKINS ALL CHILDREN'S HOSPITAL

      St. petersburg

      FLORIDA, UNITED STATES

      Recrutement local
      État du recrutement: FERMÉ
    • MOFFITT CANCER CENTER

      Tampa

      FLORIDA, UNITED STATES

      Recrutement local
      État du recrutement: FERMÉ
    • MONTEFIORE MEDICAL CANCER CENTER

      The bronx

      NEW YORK, UNITED STATES

      Recrutement local
      État du recrutement: FERMÉ
    • NATIONWIDE CHILDREN'S HOSPITAL

      Columbus

      OHIO, UNITED STATES

      Recrutement local
      État du recrutement: FERMÉ
    • PRIMARY CHILDREN'S MEDICAL CENTER/UTAH

      Salt lake city

      UTAH, UNITED STATES

      Recrutement local
      État du recrutement: FERMÉ
    • ROSWELL PARK COMPREHENSIVE CANCER CENTER

      Buffalo

      NEW YORK, UNITED STATES

      Recrutement local
      État du recrutement: FERMÉ

    Dernière modification : 25 novembre 2025
    Données à jour depuis : 10 mars
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT04388839