Trial Title:
Omental Tissue Autograft in Human Recurrent Glioblastoma Multiforme (rGBM)
NCT ID:
NCT05979064
Condition:
Glioma
Glioma, Malignant
Glioblastoma
Glioblastoma Multiforme
Glioblastoma Multiforme of Brain
GBM
Brain Cancer
High Grade Glioma
Conditions: Official terms:
Glioblastoma
Glioma
Brain Neoplasms
Conditions: Keywords:
blood brain barrier
omentum autograft
omental autograft
omentum
omental
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Laparoscopically harvested omental tissue autograft
Description:
1. Standard neurosurgical removal of recurrent GBM,
2. removal of fat from abdomen called omentum using a thin tube with a camera
(laparoscopically),
3. the omental fat will be transferred and implanted into brain tumor cavity,
4. standard closure of surgical resection cavity.
Arm group label:
Laparoscopically harvested omental tissue autograft
Summary:
This single center, single arm, open-label, phase I study will assess the safety of
laparoscopically harvested autologous omentum, implanted into the resection cavity of
recurrent glioblastoma multiforme (GBM) patients.
Detailed description:
Laparoscopically harvested omental grafts are commonly used to fill surgical cavities
after resection of head and neck cancers. Investigators hypothesize that an omental
tissue graft implanted into our patients with resected recurrent GBM may be used as a
readily available and accessible means of circumventing the blood brain barrier (BBB)
selectively and focally. The laparoscopically harvested omental graft omentum would
easily conform to many resected GBM cavities in our human patients with acceptable risk.
The predictable and rich vascular anatomy of a laparoscopically harvested piece of
omentum makes it an ideal tissue for cases of previously irradiated and/or infected wound
beds. This is why it is successfully used in head and neck and skull base tumors. The
permeability of the new blood vessels formed between the omental graft and the cortical
brain surface should allow for improved delivery of chemotherapeutics and immune cells
(macrophages and T cells) into the vicinity, extracellular space and microenvironment of
the resected tumor cavity including the brain adjacent to the tumor (BAT). Milky spots
within the greater omentum are very small white-coloured areas of lymphoid tissue will
also provide direct deposition of immune cells such as dendritic, macrophages and
lymphocytes into the milieu of the resected GBM. The milky spots are made up of
mesenchymal cells and are covered in a layer of mesothelium. These structures surround
the small blood vessels. The enclosing mesothelium contains macrophages, lymphocytes and
mast cells. They are also known as secondary lymphoid organs. Most milky spots contain
extremely thin-walled lymphatic capillaries. In addition, the technique of fat grafting
has been reliably used since 1990 as a way to improve and enhance wound healing, scar
healing, as well as tissue augmentation and tissue repair following radiation injury.
All subjects included in the study will undergo standard surgical resection for diagnosed
recurrent GBM. Following the resection, the surgical cavity will be lined with a
laparoscopically harvested piece of autologous omentum. The patient's dura, bone and
scalp will be closed as is customary. The subject will be followed for side effects
within 72 hours, 7 days, 30 days, 60 days, 120 days and 180 days. Risk assessment will
include seizure, stroke, infection, tumor progression, and death.
The investigators aim to prove that this commonly surgical technique for head and neck
cancers and reconstructive surgery is safe in a small human cohort of patients with
resected recurrent GBM and may improve progression-free survival (PFS) and overall
survival (OS).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subject is a male or female 18 years of age or older.
2. Subject is undergoing planned resection of known or suspected GBM.
3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.
4. Subject has a life expectancy of at least 6 months, in the opinion of the
Investigator.
5. Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate
for ≥ 80% resection of enhancing region.
6. Subject must be able to undergo MRI evaluation.
7. Subject meets the following laboratory criteria:
1. White blood count ≥ 3,000/μL
2. Absolute neutrophil count ≥ 1,500/μL
3. Platelets ≥ 100,000/μL
4. Hemoglobin > 10.0 g/dL (transfusion and/or ESA allowed)
5. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of
normal (ULN)
6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x ULN
7. Blood urea nitrogen (BUN) and creatinine < 1.5 x ULN
8. Females of reproductive potential must have a negative serum pregnancy test and be
willing to use an acceptable method of birth control.
9. Able to understand and willing to sign an institutional review board (IRB)- approved
written informed consent document
Inclusion criteria considered during surgery:
1. Subject has a histologically confirmed (frozen section) diagnosis of recurrent WHO
Grade IV glioblastoma multiforme (GBM).
2. Omental graft is technically feasible.
Exclusion Criteria:
1. Subject, if female, is pregnant or is breast feeding.
2. Subject intends to participate in another clinical trial.
3. Subject intends to undergo treatment with the Gliadel® wafer at the time of this
surgery.
4. Subject has an active infection requiring treatment.
5. Subject has radiographic evidence of multi-focal disease or leptomeningeal
dissemination.
6. Subject has a history of other malignancy, unless the patient has been disease- free
for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin
cancer is acceptable regardless of time, as well as localized prostate carcinoma or
cervical carcinoma in situ after curative treatment
7. Subject has a known positive test for human immunodeficiency virus infection, or
active hepatitis B or hepatitis C infection.
8. Subject has a history or evidence of any other clinically significant disorder,
condition or disease that would pose a risk to subject safety or interfere with the
study evaluation, procedures or completion.
9. Subject has had prior abdominal surgery.
10. Subject has severe renal insufficiency rendering gadolinium MRI contraindicated.
11. Subject who are unable to have an MRI scan for any reason.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Lenox Hill Brain Tumor Center
Address:
City:
New York
Zip:
10075
Country:
United States
Status:
Recruiting
Contact:
Last name:
John Boockvar, MD
Phone:
212-434-3900
Email:
jboockvar@northwell.edu
Contact backup:
Last name:
Tamika Wong, MPH
Phone:
212-434-4836
Email:
twong4@northwell.edu
Investigator:
Last name:
John Boockvar, MD
Email:
Principal Investigator
Investigator:
Last name:
David Langer, MD
Email:
Sub-Investigator
Investigator:
Last name:
Robert A Andrews, MD
Email:
Sub-Investigator
Investigator:
Last name:
Netanel Ben-Shalom, MD
Email:
Sub-Investigator
Investigator:
Last name:
Avraham Zlochower, MD
Email:
Sub-Investigator
Investigator:
Last name:
Tamika Wong, MPH
Email:
Sub-Investigator
Investigator:
Last name:
Vadim Zhigin, PA-C
Email:
Sub-Investigator
Investigator:
Last name:
Olivia Albers, NP
Email:
Sub-Investigator
Investigator:
Last name:
Amy McKeown, NP
Email:
Sub-Investigator
Start date:
April 4, 2023
Completion date:
April 2027
Lead sponsor:
Agency:
Northwell Health
Agency class:
Other
Source:
Northwell Health
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05979064
