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Compares treatment options for Glioblastoma
Official title Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM
ClinicalTrials.gov ID: NCT05271240
What this study is testing
What is Repeated Superselective Intraarterial Cerebral infusion (SIACI) of Bevacizumab (Avastin) with Temozolomide and Radiation?
Repeated Superselective Intraarterial Cerebral infusion (SIACI) of Bevacizumab (Avastin) with Temozolomide and Radiation is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for glioblastoma.
Also referred to as IA BV+TMZ/RT, Intraarterial Bevacizumab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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).
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.