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

Trial ID: NCT05954858

Interventional - Phase Unknown - Recruiting

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).

Conditions

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

Interventions

• Tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap to bypass the blood brain barrier (BBB)

Eligibility

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).
• 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.

Sponsor

Northwell Health

Source: ClinicalTrials.gov

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