Status:
RECRUITING
Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM
Lead Sponsor:
Northwell Health
Conditions:
Glioblastoma
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 therap...
Detailed Description
Those randomized to the treatment group (IA BV+TMZ/RT )the experimental aspects will include: 1. Subjects will first be treated with Mannitol prior to IA BV infusion. Mannitol is delivered IA, 12.5 m...
Eligibility Criteria
Inclusion
- Subject is a male or female 18 years of age or older.
- Subject has a confirmed diagnosis of GBM according to the 2021 WHO Classification of Tumors of the CNS. Accordingly, eligible GBM patients will comprise only IDH-wild type astrocytomas with microvascular proliferation or necrosis or one or more of 3 genetic parameters (TERT promoter mutations, EGFR gene amplification, or combined gain of entire chromosome 7 and loss of entire chromosome 10).
- Subject has a Karnofsky Performance Status (KPS) 70% or greater.
- Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.
- Subject must be able to undergo MRI evaluation.
- Subject meets the following laboratory criteria:
- i. White blood count ≥ 3,000/μL ii. Absolute neutrophil count ≥ 1,500/μL iii. Platelets ≥ 100,000/μL iv. Hemoglobin \> 10.0 g/dL (transfusion and/or ESA allowed) v. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN) vi. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x ULN vii. Blood urea nitrogen (BUN) and creatinine \< 1.5 x ULN
- Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.
- Males of reproductive potential must be willing to use an acceptable method of birth control to ensure effective contraception with partner.
- Able to understand and willing to sign an institutional review board (IRB)-approved written informed consent document (legally authorized representative permitted).
Exclusion
- Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM.
- Subject has an IDH mutant astrocytoma or other non GBM brain tumor according to the 2021 WHO classification of Tumors of the CNS.
- Subject intends to participate in another clinical trial
- Subject has an active infection requiring treatment.
- Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.
- 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
- Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.
- 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.
- Subject, if female, is pregnant or is breast feeding.
Key Trial Info
Start Date :
April 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
432 Patients enrolled
Trial Details
Trial ID
NCT05271240
Start Date
April 27 2022
End Date
April 1 2028
Last Update
September 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Lenox Hill Brain Tumor Center
New York, New York, United States, 10075