About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Patients who are undergoing needle biopsy only or non-eligible for a surgical intervention
Tumors located solely in the brain stem, midbrain, or thalamus without inclusion/involvement of surrounding brain matter
Previous treatment with bevacizumab
Radiographic evidence of leptomeningeal disease
Trial design
Treatments tested in this trial
- Allogeneic Adipose-derived Mesenchymal Stem Cells
- Biospecimen Collection
- Craniotomy
- Magnetic Resonance Imaging
- Ommaya Reservoir Tap