Adipose-Derived Mesenchymal Stem Cells (AMSCs) For Recurrent Glioblastoma

Overview

Información sobre este estudio

This study aims to evaluate the safety of local delivery of AMSCs for recurrent GBM by noting the incidence of adverse events, as well as radiological and clinical progression.

To assess the preliminary efficacy of local delivery of AMSCs for recurrent GBM by comparing the clinical, survival, progression, and radiographic outcomes from patients enrolled in our study to historical controls from our institution.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Participants ≥ 18 years < 65 years of age.
  • KPS ≥ 60.
  • Negative pregnancy test done < 7 days prior to registration, for persons of childbearing potential only.
  • Patients with a previous histological diagnosis of GBM that show recurrence at the same location, who are candidates to- and will undergo a redo craniotomy for excision of recurrent tumor.  
  • Patients have undergone previous standard of care as outlined by Stupp et al. (2004) which include maximal safe resection followed by concomitant radiation therapy and chemotherapy with oral temozolomide.  
  • There is measurable disease according to the iRANO criteria defined in section “11.2.1 Measurable Disease” of this protocol.  
  • Adequate organ function as assessed by the following laboratory values ≤ 3 weeks prior to registration:
    • Serum creatinine and urea ≤ 2 times the upper limit of normal;
    • ALT, AST and alkaline phosphatase ≤ 3 times the upper limit of normal, and bilirubin ≤ 2.5 mg/dL;
    • Prothrombin time ≤1.5 times upper limit of normal;
    • INR and PTT ≤ 1.5 times the upper limit of normal;
    • Hemoglobin ≥ 9 g/dL;
    • Platelets ≥ 100 x 10^9/L;
    • Absolute Neutrophil Count (ANC) ≥ 1.5 x 10^9/L.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
  • Patient or Legally Authorized Representative (LAR) is able to fully understand and provide written and verbal consent for the protocol.
  • Willingness to provide mandatory blood specimens for correlative research.
  • Willingness to provide mandatory tissue specimens for correlative research.
  • Willingness to undergo Ommaya reservoir placement and provide CSF samples for correlative research.

Exclusion Criteria:

  • Patients who are undergoing biopsy only or non-eligible for a surgical intervention.
  • Tumors located in the brain stem, midbrain, or thalamus.
  • Previous treatment with Bevacizumab.
  • Radiographic evidence of leptomeningeal disease.

Eligibility last updated 3/2/23. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Alfredo Quinones-Hinojosa, M.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available

Información adicional de contacto

Formulario de contacto para ensayos sobre cáncer

Teléfono: 855-776-0015 (toll-free)

Preguntas de estudios clínicos para pacientes internacionales