Trial Title:
Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Recurrent Glioblastoma or Recurrent Astrocytoma in Patients Undergoing Craniotomy
NCT ID:
NCT05789394
Condition:
Recurrent Glioblastoma, IDH-Wildtype
Recurrent Astrocytoma, IDH-Mutant, Grade 4
Astrocytoma, Grade IV
Conditions: Official terms:
Glioblastoma
Astrocytoma
Recurrence
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Allogeneic Adipose-derived Mesenchymal Stem Cells
Description:
Receive IT
Arm group label:
Treatment (AMSCs)
Other name:
Allogeneic Adipose-derived MSCs
Other name:
Allogeneic Adipose-derived Stem/Stromal Cells
Other name:
Allogeneic Mesenchymal Stem/Stromal Cells
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood and tissue sample collection
Arm group label:
Treatment (AMSCs)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Craniotomy
Description:
Undergo craniotomy
Arm group label:
Treatment (AMSCs)
Other name:
incision of the skull
Other name:
Open Craniotomy
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (AMSCs)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
MRIs
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Procedure
Intervention name:
Ommaya Reservoir Tap
Description:
Undergo Ommaya reservoir placement for collection of CSF
Arm group label:
Treatment (AMSCs)
Other name:
Ommaya Reservoir Access
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.
Detailed 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 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, tissue sample and cerebrospinal fluid
(CSF) sample collection on study.
After completion of study treatment patients are followed up every 2 months for 1 year.
Criteria for eligibility:
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 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 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
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224-9980
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Alfredo Quinones-Hinojosa, M.D.
Email:
Principal Investigator
Start date:
June 16, 2023
Completion date:
July 24, 2025
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05789394
https://www.mayo.edu/research/clinical-trials
