RECRUITING

Omental Tissue Autograft in Human Recurrent Glioblastoma Multiforme (rGBM)

Conditions

Glioma Glioma, Malignant Glioblastoma Glioblastoma Multiforme Glioblastoma Multiforme of Brain GBM Brain Cancer High Grade Glioma blood brain barrier omentum autograft omental autograft omentum omental

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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 I study will assess the safety of laparoscopically harvested autologous omentum, implanted into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.

Official Title

Laparoscopically Harvested Omental Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)

Quick Facts

Study Start:2023-04-04

Study Completion:2027-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05979064

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. Able to understand and willing to sign an institutional review board (IRB)- approved written informed consent document 1. Subject has a histologically confirmed (frozen section) diagnosis of recurrent WHO Grade IV glioblastoma multiforme (GBM). 2. Omental graft is technically feasible.	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.

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. Able to understand and willing to sign an institutional review board (IRB)- approved written informed consent document
1. Subject has a histologically confirmed (frozen section) diagnosis of recurrent WHO Grade IV glioblastoma multiforme (GBM).
2. Omental graft is technically feasible.

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.

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

Northwell Health

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, Northwell Health

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 Date2023-04-04

Study Completion Date2027-04

Study Record Updates

Study Start Date2023-04-04

Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

blood brain barrier
omentum autograft
omental autograft
omentum
omental

Additional Relevant MeSH Terms

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