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Clinical Trial 20015

Cancer Type: Neurologic Oncology
Interventions:Avastin (Bevacizumab); Bevacizumab ()

Study Type: Diagnostic
Phase of Study: N/A
Investigators:

  • Peter Forsyth

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

Change in Relative Cerebral Blood Volume as a Biomarker for Early Response to Bevacizumab in Patients with Recurrent Glioblastoma

Summary

Objective

To determine whether binary changes (increase vs. decrease) in normalized rCBV within enhancing tumor from baseline scan (S0) to post-dose 1 treatment scan (S1) is associated with overall survival (OS).

Inclusion Criteria

Inclusion Criteria: Histologically proven intracranial glioblastoma or gliosarcoma at initial surgery Patients will be eligible if the original histology was low-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma is made (high-grade transformation) Karnofsky performance status >= 70 Women must not be pregnant or breast-feeding Progression of disease assessed by local site using Revised Assessment in Neuro-Oncology (RANO) criteria, with plan to give whole-dose bevacizumab therapeutically, either as single therapy or in conjunction with other chemotherapeutic regimens; patients getting bevacizumab to support additional radiation therapy or immunotherapy, or primarily for reduction of edema rather than for tumor treatment, are excluded; this must be the patient?s initial recurrence Patient must not have been treated previously with immunotherapies (vaccines, checkpoint inhibitors, T-cells) Intratumoral hemorrhage (acute, subacute, or chronic) as seen on hemosiderin-sensitive (gradient-echo) MRI may preclude patient inclusion because of anticipated limited evaluation due to magnetic susceptibility artifact on the heavily T2-weighted DSC-MRI images; if the region of enhancing tumor not affected by blooming artifact on the hemosiderin-sensitive images does not meet the 10 x 10 x 10 mm ?measurable enhancement? threshold specified elsewhere, the patient is ineligible Progressive enhancement (> 25% increase in contrast enhancing volume compared to nadir) on MRI within 14 days of registration, >= 42 days since completion of radiation/temozolomide therapy, and >= 28 days since surgical resection or cytotoxic chemotherapy; measurable enhancement is defined as two perpendicular in-plane diameters of at least 10 mm and at least 10 mm in the 3rd orthogonal direction Patients must be able to tolerate brain MRI scans with dynamic intravenous gadolinium-based contrast agent injections Ability to withstand 22 gauge intravenous (IV) placement No history of untreatable claustrophobia No magnetic resonance (MR) incompatible implants/devices or metallic foreign bodies No contraindication to intravenous contrast administration Adequate organ function, including adequate renal function defined as estimated glomerular filtration rate (eGFR) >= 40 mL/min/1.73 m^2 as calculated per institution standard of care, and meeting local site requirements for intravenous administration of gadolinium-based MRI contrast agents No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance Weight compatible with limits imposed by the MRI scanner table Patient must be scheduled to receive treatment with a standard dose regimen of bevacizumab (bevacizumab infusion on days 1 and 15 of a 28-day treatment cycle); patient can be treated with bevacizumab alone or in combination with other chemotherapies