Surgical technique to improve outcomes in glioblastoma patients

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

This study is testing a new surgical method using special tissue flaps to see if it can help people with newly diagnosed glioblastoma live longer and have fewer problems after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Northwell Health (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (New York, New York)
• Trial ID: NCT05954858 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of using a pedicled temporoparietal fascial flap or pericranial flap in the surgical treatment of newly diagnosed glioblastoma multiforme patients. After standard surgical resection, the flap is placed in the resection cavity to potentially enhance progression-free survival and overall survival. The study will monitor patients for side effects and outcomes over a period of 180 days, with a focus on assessing the effectiveness of this innovative surgical approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are undergoing planned resection for glioblastoma and have a Karnofsky Performance Status of 70% or greater.

Not a fit: Patients with a life expectancy of less than 6 months or those unable to undergo MRI evaluation may not benefit from this study.

Why it matters

Potential benefit: If successful, this technique could significantly improve survival rates for patients with glioblastoma.

How similar studies have performed: Previous studies have shown initial safety for similar surgical techniques, but this specific approach is novel.

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.

Where this trial is running

New York, New York

• Lenox Hill Brain Tumor Center — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: John Boockvar, MD — Feinstein Institute for Medical Research/Lenox Hill Hospital
• Study coordinator: John Boockvar, MD

Conditions Glioma, Malignant; Glioblastoma; Glioblastoma Multiforme; Glioblastoma Multiforme, Adult; High Grade Glioma; GBM; Brain Cancer; tissue autograft