Omental Tissue Autograft in Human Recurrent Glioblastoma Multiforme (rGBM)

Part of paid clinical trials in New York, New York.

Sponsor
Northwell Health
Study ID
NCT05979064
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Laparoscopically harvested omental tissue autograft — PROCEDURE
    1. Standard neurosurgical removal of recurrent GBM, 2. removal of fat from abdomen called omentum using a thin tube with a camera (laparoscopically), 3. the omental fat will be transferred and implanted into brain tumor cavity, 4. standard closure of surgical resection cavity.

Study Details

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.

Key Dates

Start date
Apr 4, 2023
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Laparoscopically harvested omental tissue autograft
    Use of laparoscopically harvested omental autografts into the resection cavity of recurrent glioblastoma multiforme (rGBM) patients.

Primary Outcome Measure

Safety parameter: proportion of patients experiencing rapidly progressive disease as indicated by MRI using RANO Criteria harvested omental graft for recurrent glioblastoma multiforme (rGBM). [ Time Frame: Study Day 1 - Day 180 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lenox Hill Brain Tumor CenterNew YorkNew York10075
John Boockvar, MD
[email protected]
212-434-3900
Tamika Wong, MPH
[email protected]
212-434-4836
John Boockvar, MD (PRINCIPAL_INVESTIGATOR)
David Langer, MD (SUB_INVESTIGATOR)
Robert A Andrews, MD (SUB_INVESTIGATOR)
Netanel Ben-Shalom, MD (SUB_INVESTIGATOR)
Avraham Zlochower, MD (SUB_INVESTIGATOR)
Tamika Wong, MPH (SUB_INVESTIGATOR)
Vadim Zhigin, PA-C (SUB_INVESTIGATOR)
Olivia Albers, NP (SUB_INVESTIGATOR)
Amy McKeown, NP (SUB_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Lenox Hill Brain Tumor Center· New York, NY

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