Actively Recruiting
Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM
Led by Northwell Health · Updated on 2024-09-19
432
Participants Needed
1
Research Sites
309 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the most common form of primary brain cancer, afflicting approximately 7,000 patients in the United States each year. These highly malignant cancers remain a significant unmet clinical need in oncology. The investigators have completed a Phase I clinical trial that has shown that Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (BV) is safe up to a dose of 15mg/kg in patients with recurrent malignant glioma. Additionally, the investigators have shown in a recently completed Phase I/II clinical trial, that SIACI BV improves the median progression free survival (PFS) from 4-6 months to 11.5 months and overall survival (OS) from 12-15 months to 23 months in patients with newly diagnosed GBM. Therefore, this two-arm, randomized trial (2:1) is a follow up study to these trials and will ask simple questions: Will this repeated SIACI treatment regimen increase progression free survival (PFS-primary endpoint) and overall survival (OS-secondary endpoint) when compared with standard of care in patients with newly diagnosed GBM? Exploratory endpoints will include adverse events and safety analysis as well as quality of life (QOL) assessments. The investigators expect that this project will provide important information regarding the utility of repeated SIACI BV therapy for newly diagnosed GBM and may alter the way these drugs are delivered to our patients in the near future.
CONDITIONS
Official Title
Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years of age or older
- Confirmed diagnosis of glioblastoma IDH-wild type as defined by 2021 WHO CNS tumor classification
- Karnofsky Performance Status of 70% or greater
- Life expectancy of at least 6 months as judged by Investigator
- Able to undergo MRI evaluation
- Laboratory criteria: white blood count 2,000/bcL or more, neutrophils 1,500/bcL or more, platelets 100,000/bcL or more, hemoglobin above 10.0 g/dL, bilirubin and alkaline phosphatase up to 2 times upper normal limit, AST and ALT less than 3 times upper normal limit, BUN and creatinine less than 1.5 times upper normal limit
- Females of reproductive potential must have a negative pregnancy test and use acceptable birth control
- Males of reproductive potential must use acceptable birth control
- Able to understand and willing to sign IRB-approved informed consent
You will not qualify if you...
- Already started chemotherapy or radiation for glioblastoma
- Diagnosis of IDH mutant astrocytoma or other non-glioblastoma brain tumor
- Planning to participate in another clinical trial
- Active infection needing treatment
- Multifocal disease or leptomeningeal spread seen on scans
- History of other cancers unless disease-free for 5 years; treated basal or squamous skin cancer, localized prostate or cervical carcinoma in situ allowed
- Known HIV, active hepatitis B or C infection
- Any other serious medical condition posing risk or interfering with study
- Pregnant or breastfeeding females
AI-Screening
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Trial Site Locations
Total: 1 location
1
Lenox Hill Brain Tumor Center
New York, New York, United States, 10075
Actively Recruiting
Research Team
J
John Boockvar, MD
CONTACT
T
Tamika Wong, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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