Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Recurrent Glioblastoma in Patients Undergoing Craniotomy

Study Purpose

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 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 GBM 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 GBM during a craniotomy could improve the long-term outcomes of these patients by decreasing the progression rate and invasiveness of malignant cells.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Participants >= 18 years < 65 years of age.

- 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 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 immunotherapy response assessment in neuro-oncology (iRANO) criteria.

- Serum creatinine and urea <= 2 times the upper limit of normal (=< 3 weeks prior to registration) - Alanine transaminase (ALT), aspartate transferase (AST) and alkaline phosphatase =< 3 times the upper limit of normal, and bilirubin =< 2.5 mg/dL (=< 3 weeks prior to registration) - Prothrombin time =< 1.5 times upper limit of normal (=< 3 weeks prior to registration) - International normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 times the upper limit of normal (=< 3 weeks prior to registration) - Hemoglobin >= 9 g/dL (=< 3 weeks prior to registration) - Platelets >= 100 x 10^9/L (=< 3 weeks prior to registration) - Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (=< 3 weeks prior to registration) - 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 cerebrospinal fluid (CSF) samples for correlative research.

Exclusion Criteria:

- Patients who are undergoing needle 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05789394
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mayo Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Alfredo Quinones-Hinojosa
Principal Investigator Affiliation	Mayo Clinic
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Recurrent Glioblastoma
Study Website:	View Trial Website

Additional Details

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 application of AMSCs through cytokine analysis on peripheral blood samples.

II. To explore the local changes on the brain parenchyma by analyzing tissue at recurrence.

III. To explore the presence of AMSCs on brain tissue at recurrence.

OUTLINE: This is a dose-escalation study. Patients receive AMSCs intratumorally (IT) and undergo Ommaya reservoir placement during a craniotomy on study. Patients also undergo magnetic resonance imaging (MRI) on study and during follow-up, as well as blood sample and cerebrospinal fluid (CSF) sample collection on study.

Arms & Interventions

Arms

Experimental: Treatment (AMSCs)

Patients receive AMSCs IT and undergo Ommaya reservoir placement during a craniotomy on study. Patients also undergo MRI on study and during follow-up, as well as blood sample and CSF sample collection on study.

Interventions

Biological: - Allogeneic Adipose-derived Mesenchymal Stem Cells

Receive IT

Procedure: - Biospecimen Collection

Undergo blood sample collection

Procedure: - Craniotomy

Undergo craniotomy

Procedure: - Magnetic Resonance Imaging

Undergo MRI

Procedure: - Ommaya Reservoir Tap

Undergo Ommaya reservoir placement for collection of CSF

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic in Florida, Jacksonville, Florida

Status

Recruiting

Address

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980

Site Contact

Clinical Trials Referral Office

[email protected]

855-776-0015

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