Phase 1, Dose Escalation, Non-Randomized, Open Label, Clinical Trial Evaluating the Safety and Preliminary Efficacy of Allogenic Adipose-Derived Mesenchymal Stem Cells (AMSCs) for Recurrent Glioblastoma
Mayo Clinic
Summary
This phase I trial tests the safety, side effects, and best dose of allogenic adipose-derived mesenchymal stem cells (AMSCs) in treating patients with glioblastoma or astrocytoma that has come back (recurrent) who are undergoing brain surgery (craniotomy). Glioblastoma is the most common and most aggressive form of primary and malignant tumor of the brain. Currently, the standard of care for this disease includes surgical resection, followed by radiation with chemotherapy and tumor treating fields. Despite this aggressive therapy, the survival after finishing treatment remains low and the disease often reoccurs. Unfortunately, the available therapy options for recurrent glioblastoma are minimal and do not have a great effect on survival. AMSCs are found in body fat and when separated from the fat, are delivered into the surgical cavity at the time of surgery. When in direct contact with tumor cells, AMSCs affect tumor growth, residual tumor cell death, and chemotherapy resistance. The use of AMSCs delivered locally into the surgical cavity of recurrent glioblastoma during a craniotomy could improve the long-term outcomes of these patients by decreasing the progression rate and invasiveness of malignant cells.
Description
PRIMARY OBJECTIVE: I. To establish the maximum tolerated dose (MTD) of locally delivered adipose-derived mesenchymal stem cells (AMSCs) in patients with recurrent glioblastoma (GBM). SECONDARY OBJECTIVES: I. To assess the safety and toxicity profile of locally delivered AMSCs in patients with recurrent GBM. II. To assess overall survival (OS) in recurrent GBM patients treated with locally delivered AMSCs. III. To assess progression free survival (PFS) in recurrent GBM patients treated with locally delivered AMSCs. CORRELATIVE OBJECTIVES: I. To explore the systemic immune response after…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants \>= 18 years * Karnofsky Performance Scale (KPS) \>= 60 * Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only * Patients with a previous histological diagnosis of glioblastoma multiforme, isocitrate dehydrogenase (IDH) wildtype (WT) or astrocytoma, IDH-mutant World Health Organization (WHO) grade IV according to the 2021 WHO classification of tumors of the central nervous system , who are candidates to- and will undergo a redo craniotomy for excision of recurrent tumor * There is measurable disease accord…
Interventions
- BiologicalAllogeneic Adipose-derived Mesenchymal Stem Cells
Receive IT
- ProcedureBiospecimen Collection
Undergo blood and tissue sample collection
- ProcedureCraniotomy
Undergo craniotomy
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedureOmmaya Reservoir Tap
Undergo Ommaya reservoir placement for collection of CSF
Location
- Mayo Clinic in FloridaJacksonville, Florida