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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Alfredo Quinones-Hinojosa, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions