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New treatment option for Recurrent Glioblastoma
Official title Spectroscopic MRI, Proton Therapy, and Avastin for Recurrent Glioblastoma
ClinicalTrials.gov ID: NCT05284643
What this study is testing
What is Bevacizumab?
Bevacizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent glioblastoma.
Also referred to as Avastin.
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
- The purpose of this research is to find hidden cancer with an experimental magnetic resonance imaging (MRI) scan called spectroscopic magnetic resonance imaging (sMRI). That spectroscopic MRI scan will be used to increase the area of the brain receiving radiation and then the dose of radiation in attempt to kill more of the cancer.
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
- A. Recurrent glioblastoma (or variants such as gliosarcoma) based on one of the following criteria:
- An area of MRI enhancement consistent with glioblastoma outside of the initial high dose radiation field.
- Biopsy or resection proven recurrent glioblastoma.
- Progressive glioblastoma based on advanced imaging (brain positron emission tomography (PET), perfusion MRI, or clinical MR Spectroscopy) B...
- For "marginal" or "out of field" radiation failures where at least half of the enhancing disease is outside of the prior high dose radiation field...
You likely can't join if
- A. Brain malignancies other than glioblastoma (or variants such as gliosarcoma) by WHO 2021 criteria (benign lesions like meningioma are allowed) B...
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration.
- Transmural myocardial infarction within the last 6 months prior to registration.
- History of stroke or transient ischemic attack within 6 months prior to registration.
- Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease.
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
See the full eligibility criteria
- A. Recurrent glioblastoma (or variants such as gliosarcoma) based on one of the following criteria:
- An area of MRI enhancement consistent with glioblastoma outside of the initial high dose radiation field.
- Biopsy or resection proven recurrent glioblastoma.
- Progressive glioblastoma based on advanced imaging (brain positron emission tomography (PET), perfusion MRI, or clinical MR Spectroscopy) B. Pathology diagnosis of glioblastoma, or variants such as gliosarcoma, on...
- For "marginal" or "out of field" radiation failures where at least half of the enhancing disease is outside of the prior high dose radiation field but there is field overlap, patients must have completed prior radiation...
- For "in field" radiation failures where at least half of the enhancing disease is within the prior high dose radiation field, patients must have completed prior radiation at least six months or more prior to study...
- 28 days or 5 half-lives, whichever is shorter, elapsed from the administration of any experimental agent prior to initiation of study treatment.
- 28 days elapsed from the administration of any prior cytotoxic agents except i. 14 days from vincristine and ≥ 21 days from procarbazine and Temozolomide (TMZ) prior to initiation of study treatment. G. Age at least 18...
- [urine protein]/[urine creatinine]: if both protein and creatinine are reported in mg/dL
- [(urine protein) x0.088]/[urine creatinine]: if urine creatinine is reported in mmol/L Q. Patients on full-dose anticoagulants must meet both of the following criteria:
- No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
- In-range international normalized ratio (INR) (typically 2-3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin, within 21 days prior to registration
- A. Brain malignancies other than glioblastoma (or variants such as gliosarcoma) by WHO 2021 criteria (benign lesions like meningioma are allowed) B. Glioma that has not previously undergone standard first line therapies...
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration.
- Transmural myocardial infarction within the last 6 months prior to registration.
- History of stroke or transient ischemic attack within 6 months prior to registration.
- Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease.
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function other than screening panel (Section 3.1) and coagulation parameters are not...
- Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with...
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, 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 Miami, Florida, 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.