Trial Title:
Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma
NCT ID:
NCT05954858
Condition:
Glioma, Malignant
Glioblastoma
Glioblastoma Multiforme
Glioblastoma Multiforme, Adult
High Grade Glioma
GBM
Brain Cancer
Conditions: Official terms:
Glioblastoma
Glioma
Brain Neoplasms
Conditions: Keywords:
tissue autograft
blood brain barrier
pedicled temporoparietal fascial
pericranial flap
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:
Tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap to bypass the blood brain barrier (BBB)
Description:
Surgical tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap
into the resection cavity of newly diagnosed glioblastoma multiforme (GBM) patients.
Arm group label:
Surgical tissue autograft: TPF flap/pericranial flap
Other name:
surgical tissue flap
Other name:
tissue autograft
Summary:
This single center, single arm, open-label, phase 2 study will assess the safety and
efficacy of a pedicled temporoparietal fascial (TPF) or pericranial flap into the
resection cavity of newly diagnosed glioblastoma multifome (GBM) patients.
The objective of the Phase 2 study is to demonstrate that this surgical technique is safe
and effective in a human cohort of patients with resected newly diagnosed AA or GBM and
may improve progression-free survival (PFS) and overall survival (OS).
Detailed description:
Glioblastoma (GBM) is the most common primary central nervous system malignancy in
adults, and accounts for over half of all malignant brain tumors. The prognosis for newly
diagnosed GBM is extremely poor even with Stupp protocol consisting of surgery followed
by temozolomide and radiotherapy. For newly diagnosed GBM the median overall survival
(OS) is only 15 months, and the median progression-free survival (PFS) is a mere 5-6
months with only 53.9% of patients having 6 month PFS.
This Phase 2 study is an extension of our recently completely enrolled Phase I trial
which showed the initial safety of a TPF into the resection cavity of newly diagnosed
GBM. All 36 subjects included in this Phase 2 study will initially undergo standard
surgical resection for newly diagnosed GBM. Following the resection, the surgical cavity
will be lined with a long pedicled, autologous piece of tissue called a temporoparietal
fascial flap or pericranium. The patient's dura, bone and scalp will be closed as is
customary. The subject will be followed for side effects at 72 hours, 7 days, 30 days, 60
days, 120 days and 180 days. The primary outcome measure will be progression free
survival (PFS) and secondary outcome measures will include overall survival (OS). Risk
assessment will include seizure, stroke, infection, tumor progression, and death.
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. Males of reproductive potential must be willing to use an acceptable method of birth
control to ensure effective contraception with partner.
10. Able to understand and willing to sign an institutional review board (IRB)- approved
written informed consent document (legally authorized representative permitted).
Inclusion criteria considered during surgery:
1. Subject has a histologically confirmed (frozen section) diagnosis of WHO Grade IV
glioblastoma multiforme (GBM).
2. TPFF and/or pericranial flap is technically feasible.
Exclusion Criteria:
1. Subject, if female, is pregnant or is breast feeding.
2. Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM.
3. Subject intends to participate in another clinical trial
4. Subject intends to undergo treatment with the Gliadel® wafer at the time of this
surgery.
5. Subject has an active infection requiring treatment.
6. Subject has radiographic evidence of multi-focal disease or leptomeningeal
dissemination.
7. 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
8. Subject has a known positive test for human immunodeficiency virus infection, or
active hepatitis B or hepatitis C infection.
9. 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.
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:
twong4@northwell.edu
Contact backup:
Last name:
Tamika Wong, MPH
Phone:
212-434-4836
Email:
twong4@northwell.edu
Investigator:
Last name:
David Langer, MD
Email:
Sub-Investigator
Investigator:
Last name:
Netanel Ben-Shalom, MD
Email:
Sub-Investigator
Investigator:
Last name:
Randy D'Amico, MD
Email:
Sub-Investigator
Investigator:
Last name:
Deborah Gruber, MD
Email:
Sub-Investigator
Investigator:
Last name:
Avraham Zlochower, MD
Email:
Sub-Investigator
Investigator:
Last name:
Vadim Zhigin, PA
Email:
Sub-Investigator
Investigator:
Last name:
Olivia Albers, NP
Email:
Sub-Investigator
Investigator:
Last name:
Amy McKewon, NP
Email:
Sub-Investigator
Investigator:
Last name:
Tamika Wong, MPH
Email:
Sub-Investigator
Start date:
June 29, 2023
Completion date:
June 30, 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/NCT05954858
