RECRUITING

Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma

Conditions

Glioma, Malignant Glioblastoma Glioblastoma Multiforme Glioblastoma Multiforme, Adult High Grade Glioma GBM Brain Cancer tissue autograft blood brain barrier pedicled temporoparietal fascial pericranial flap

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Glioblastoma Multiforme (GBM)

Quick Facts

Study Start:2023-06-29

Study Completion:2027-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05954858

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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). 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.	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.

Inclusion Criteria

Exclusion 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).
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.

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.

Contacts and Locations

Study Contact

John Boockvar, MD

CONTACT

212-434-3900

jboockvar@northwell.edu

Tamika Wong, MPH

CONTACT

212-434-4836

twong4@northwell.edu

Principal Investigator

John Boockvar, MD

PRINCIPAL_INVESTIGATOR

Feinstein Institute for Medical Research/Lenox Hill Hospital

Study Locations (Sites)

Lenox Hill Brain Tumor Center

New York, New York, 10075

United States

Collaborators and Investigators

Sponsor: Northwell Health

John Boockvar, MD, PRINCIPAL_INVESTIGATOR, Feinstein Institute for Medical Research/Lenox Hill Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-29

Study Completion Date2027-06-30

Study Record Updates

Study Start Date2023-06-29

Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

tissue autograft
blood brain barrier
pedicled temporoparietal fascial
pericranial flap

Additional Relevant MeSH Terms

Glioma, Malignant
Glioblastoma
Glioblastoma Multiforme
Glioblastoma Multiforme, Adult
High Grade Glioma
GBM
Brain Cancer