Clinical Trials Logo

Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04222309
Other study ID # 19-0801
Secondary ID
Status Suspended
Phase Phase 1
First received
Last updated
Start date January 6, 2020
Est. completion date January 31, 2025

Study information

Verified date August 2023
Source Northwell Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This single center, single arm, open-label, phase I study will assess the safety of a laparoscopically harvested omental free flap into the resection cavity of recurrent glioblastoma multiforme (GBM) patients. All participants included in the study will undergo standard surgical resection for diagnosed recurrent GBM. Following the resection, the surgical cavity will be lined with a laparoscopically harvested omental free flap. The participant's dura, bone and scalp will be closed as is customary. The participant will be followed for side effects within 72 hours, 7 days, 30 days, 90 days and 180 days. Risk assessment will include seizure, stroke, infection, tumor progression, and death.


Description:

Laparoscopically harvested omental free flaps are commonly used to fill surgical cavities after resection of head and neck cancers. The investigators hypothesize that a laparoscopically harvested omental free flap in our patients with resected recurrent GBM may be used as a readily available and accessible means of circumventing the blood brain barrier (BBB) selectively and focally. The laparoscopically harvested omental free flap with its long vascular pedicle length, wide rotational arc and available surface area would easily conform to many resected GBM cavities in our human patients with acceptable risk. The predictable and rich vascular anatomy of a laparoscopically harvested omental free makes it an ideal flap for cases of previously irradiated and/or infected wound beds. This is why it is successfully used in head and neck and skull base tumors. The permeability of the blood vessels of the laparoscopically harvested omental free flap should allow for improved delivery of chemotherapeutics and immune cells (macrophages and T cells) into the vicinity, extracellular space and microenvironment of the resected tumor cavity including the brain adjacent to the tumor (BAT). "Milky spots" within the omentum will also provide direct deposition of immune cells such as dendritic, macrophages and lymphocytes into the milieu of the resected GBM. The investigators aim to prove that this commonly surgical technique for head and neck cancers is safe in a small human cohort of patients with resected recurrent GBM and may improve progression-free survival (PFS).


Recruitment information / eligibility

Status Suspended
Enrollment 10
Est. completion date January 31, 2025
Est. primary completion date January 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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. Able to understand and willing to sign an institutional review board (IRB)-approved written informed consent document Inclusion criteria considered during surgery: 1. Subject has a histologically confirmed (frozen section) diagnosis of recurrent WHO Grade IV glioblastoma multiforme (GBM). 2. Omental free flap is technically feasible. Exclusion Criteria: 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.

Study Design


Intervention

Procedure:
Laparoscopically harvested omental free flap
Laparoscopically harvested omental free flap into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.

Locations

Country Name City State
United States Lenox Hill Brain Tumor Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety parameter: proportion of patients experiencing rapidly progressive disease as indicated by MRI using RANO Criteria Increase in tumor size relative to baseline will be measured using RANO and assessed by MRI throughout study at within 72 hours, 7 days, 30 days, 90 days and 180 days. Rapidly progressive disease is defined as 25% growth relative to baseline. Study Day 1-180
Primary Safety parameter: proportion of patients experiencing increase in seizures, stroke, and infection Increase in seizures (defined as 15% relative to baseline), occurrence of a stroke, or occurrence of a severe infection will be determined throughout study within 72 hours, 7 days, 30 days, 90 days and 180 days. Time Frame: Study Day 1-180
Secondary Progression Free Survival (PFS) The proportion of patients who are alive at 6 months from flap implantation and are progression-free will be estimated using standard methods for proportions, along with the associated exact 95% confidence interval. 6 months
Secondary Overall Survival (OS) OS will be calculated as the time from treatment initiation (flap implantation) to the time of death. 6 months
Secondary Percent of screen fails The number and percent of screen failures with the reason for screen failures (flap not viable etc.) will be tabulated and summarized. Study Day 1 - 24 months
See also
  Status Clinical Trial Phase
Recruiting NCT05664243 - A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma Phase 1/Phase 2
Completed NCT02768389 - Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma Early Phase 1
Recruiting NCT05635734 - Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma Phase 1/Phase 2
Completed NCT03679754 - Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102 Phase 1
Completed NCT01250470 - Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma Phase 1
Terminated NCT03927222 - Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma Phase 2
Recruiting NCT03897491 - PD L 506 for Stereotactic Interstitial Photodynamic Therapy of Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma Phase 2
Active, not recruiting NCT03587038 - OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma Phase 1
Completed NCT01922076 - Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas Phase 1
Recruiting NCT04391062 - Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma Phase 2
Active, not recruiting NCT03661723 - Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma Phase 2
Active, not recruiting NCT02655601 - Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001 Phase 2
Completed NCT02206230 - Trial of Hypofractionated Radiation Therapy for Glioblastoma Phase 2
Completed NCT03493932 - Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade Phase 1
Terminated NCT02709889 - Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06058988 - Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer Phase 2
Completed NCT03018288 - Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM) Phase 2
Not yet recruiting NCT04552977 - A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma Phase 2
Withdrawn NCT03980249 - Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells Early Phase 1
Terminated NCT02905643 - Discerning Pseudoprogression vs True Tumor Growth in GBMs