Brain Cancer
EAF151
DSC-MRI in Measuring Relative Cerebral Blood Volume for Early Response to Bevacizumab in Patients with Recurrent Glioblastoma
STATUS: Closed to Accrual
This phase II trial studies how well dynamic susceptibility contrast-enhanced magnetic resonance imaging (DSC-MRI) works in measuring relative cerebral blood volume (rCBV) for early response to bevacizumab in patients with glioblastoma that has come back. DSC-MRI may help evaluate changes in the blood vessels within the cancer to determine a patientās response to treatment.
- 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 >= 60
- Women must not be pregnant or breast-feeding as gadolinium enhanced magnetic resonance imaging (MRI) is contra-indicated
- Progression of disease assessed by local site using Revised Assessment in Neuro-Oncology (RANO) criteria, with plan to administer bevacizumab or its biosimilars, either as single therapy or in conjunction with other chemotherapeutic regimens or immunotherapy regimens, in order to treat tumor progression/recurrence per the treating physician; patients receiving bevacizumab or its biosimilars primarily for reduction of edema (i.e. alleviation of symptoms) rather than for tumor treatment are excluded; if the patientās most recent recurrence occurs while on immunotherapy, this must be judged as true recurrence using immunotherapy (i)RANO criteria
- Patients who have not previously received a bevacizumab-containing regimen or its biosimilars (i.e., this must be the first bevacizumab-containing therapy or its biosimilars administered to the patient)
- For patients with intratumoral hemorrhage (acute, subacute, or chronic) seen on hemosiderin-sensitive (gradient-echo) MRI, there must be at least 10 x 10 x 10 mm "measurable enhancement" that is not obscured or distorted by magnetic susceptibility blooming artifact
- Progressive enhancement (> 25% increase in contrast enhancing volume compared to nadir or a new measurable lesion) on MRI performed within 28 days of registration, and >= 42 days since completion of standard radiation/temozolomide therapy; adjuvant temozolimide is allowable; 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 * NOTE: If the MRI performed to identify progressive enhancement meets the dynamic susceptibility contrast (DSC)-MRI qualifications (including second dose of Gadavist) for this study and is done on a qualified scanner then this MRI may be used as the baseline (S0) DSC-MRI; bevacizumab or its biosimilars still needs to starts within 3 days of S0 scan and patient must be registered before receiving bevacizumab or biosimilar
- Patient must be cleared for administration of bevacizumab or its biosimilars with respect to any recent surgeries, and post-surgical scans must confirm the presence of measurable residual disease
- Patients must be able to tolerate brain MRI scans with Gadavist/Gadovist (gadabutrol) * 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 a treatment regimen containing bevacizumab or its biosimilars; patient can be treated with bevacizumab or its biosimilars alone or in combination with other chemotherapies or immunotherapies; patient may receive treatment with Optune * NOTE: Bevacizumab or its biosimilar should be given between 5 and 10 mg/kg IV every 2-3 weeks
United States
AZ
Phoenix
Mayo Clinic Hospital in Arizona
Contact: Site Public Contact
Saint Joseph's Hospital and Medical Center
Contact: Site Public Contact
Scottsdale
Mayo Clinic in Arizona
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Tucson
Banner University Medical Center - Tucson
Contact: Site Public Contact
Email: UACC-IIT@uacc.arizona.edu
University of Arizona Cancer Center-North Campus
Contact: Site Public Contact
Email: UACC-IIT@uacc.arizona.edu
CA
Castro Valley
Eden Hospital Medical Center
Contact: Site Public Contact
Email: Melanie.Cook@sutterhealth.org
Loma Linda
Loma Linda University Medical Center
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Los Angeles
USC / Norris Comprehensive Cancer Center
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Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
Contact: Site Public Contact
Email: ucstudy@uci.edu
Palo Alto
VA Palo Alto Health Care System
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FL
Boca Raton
Boca Raton Regional Hospital
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Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
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Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Contact: Site Public Contact
Jacksonville
Baptist MD Anderson Cancer Center
Contact: Site Public Contact
Mayo Clinic in Florida
Contact: Site Public Contact
Miami
Miami Cancer Institute
Contact: Site Public Contact
University of Miami Miller School of Medicine-Sylvester Cancer Center
Contact: Site Public Contact
Tampa
Moffitt Cancer Center
Contact: Site Public Contact
Email: ClinicalTrials@moffitt.org
Moffitt Cancer Center - McKinley Campus
Contact: Site Public Contact
Email: ClinicalTrials@moffitt.org
Moffitt Cancer Center-International Plaza
Contact: Site Public Contact
Email: ClinicalTrials@moffitt.org
GA
Atlanta
Emory University Hospital/Winship Cancer Institute
Contact: Site Public Contact
Northside Hospital
Contact: Site Public Contact
Email: ClinicalTrials@northside.com
Cumming
Northside Hospital-Forsyth
Contact: Site Public Contact
Email: clinicaltrials@northside.com
IN
Indianapolis
IU Health Methodist Hospital
Contact: Site Public Contact
Email: iutrials@iu.edu
Indiana University/Melvin and Bren Simon Cancer Center
Contact: Site Public Contact
Email: iutrials@iu.edu
KS
Kansas City
University of Kansas Cancer Center
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu
Overland Park
University of Kansas Hospital-Indian Creek Campus
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu
Westwood
University of Kansas Hospital-Westwood Cancer Center
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu
KY
Lexington
Baptist Health Lexington
Contact: Site Public Contact
MD
Baltimore
Maryland Proton Treatment Center
Contact: Site Public Contact
Email: info@mdproton.com
University of Maryland/Greenebaum Cancer Center
Contact: Site Public Contact
MI
Detroit
Henry Ford Hospital
Contact: Site Public Contact
Email: CTOResearch@hfhs.org
MN
Coon Rapids
Mercy Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Rochester
Mayo Clinic in Rochester
Contact: Site Public Contact
Saint Paul
Regions Hospital
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Email: mmcorc@healthpartners.com
United Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
MO
Columbia
MU Health - University Hospital/Ellis Fischel Cancer Center
Contact: Site Public Contact
Creve Coeur
Siteman Cancer Center at West County Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu
Saint Louis
Siteman Cancer Center-South County
Contact: Site Public Contact
Email: info@siteman.wustl.edu
Washington University School of Medicine
Contact: Site Public Contact
Email: info@siteman.wustl.edu
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu
NC
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Contact: Site Public Contact
Email: cancerclinicaltrials@med.unc.edu
Charlotte
Carolinas Medical Center/Levine Cancer Institute
Contact: Site Public Contact
Durham
Duke University Medical Center
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Greenville
East Carolina University
Contact: Site Public Contact
Email: eubankss@ecu.edu
Winston-Salem
Wake Forest University Health Sciences
Contact: Site Public Contact
NJ
Middletown
Memorial Sloan Kettering Monmouth
Contact: Site Public Contact
NM
Albuquerque
University of New Mexico Cancer Center
Contact: Site Public Contact
Email: HSC-ClinicalTrialInfo@salud.unm.edu
NY
Commack
Memorial Sloan Kettering Commack
Contact: Site Public Contact
New York
Memorial Sloan Kettering Cancer Center
Contact: Site Public Contact
Uniondale
Memorial Sloan Kettering Nassau
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West Harrison
Memorial Sloan Kettering Westchester
Contact: Site Public Contact
OH
Cincinnati
University of Cincinnati Cancer Center-UC Medical Center
Contact: Site Public Contact
Email: cancer@uchealth.com
OR
Portland
Oregon Health and Science University
Contact: Site Public Contact
Email: trials@ohsu.edu
PA
Pittsburgh
Allegheny General Hospital
Contact: Site Public Contact
RI
Providence
Rhode Island Hospital
Contact: Site Public Contact
TX
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu
Houston
Memorial Hermann Texas Medical Center
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Humble
Memorial Hermann Northeast Hospital
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
San Antonio
University Hospital
Contact: Site Public Contact
Email: evelyn.swenson-britt@uhs-sa.com
University of Texas Health Science Center at San Antonio
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Email: phoresearchoffice@uthscsa.edu
The Woodlands
Memorial Hermann The Woodlands Hospital
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Email: ecog.rss@jimmy.harvard.edu
VA
Richmond
Virginia Commonwealth University/Massey Cancer Center
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Email: CTOclinops@vcu.edu
WI
Menomonee Falls
Froedtert Menomonee Falls Hospital
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Milwaukee
Aurora Saint Luke's Medical Center
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Email: ncorp@aurora.org
Medical College of Wisconsin
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Mukwonago
ProHealth D N Greenwald Center
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Email: research.institute@phci.org
Oconomowoc
ProHealth Oconomowoc Memorial Hospital
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Waukesha
ProHealth Waukesha Memorial Hospital
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UW Cancer Center at ProHealth Care
Contact: Site Public Contact
Email: Chanda.miller@phci.org
West Bend
Froedtert West Bend Hospital/Kraemer Cancer Center
Contact: Site Public Contact
PRIMARY OBJECTIVE: I. To determine whether binary changes (increase versus [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) in recurrent glioblastoma (GBM) patients receiving bevacizumab or its biosimilars for the first time. SECONDARY OBJECTIVES: I. To determine whether the baseline S0 normalized rCBV measure alone is associated with OS. II. To determine whether change in normalized rCBV within enhancing tumor as a continuous variable is associated with OS. III. To determine whether change in normalized rCBV within enhancing tumor as a continuous variable is associated with OS when adjusting for change in enhancing tumor volume and other potential confounders. IV. To determine whether baseline cerebral blood flow (CBF) or changes in CBF are associated with OS. V. To determine the association between standardized rCBV and OS. VI. To determine whether baseline normalized rCBV or change in normalized rCBV are associated with progression-free survival (PFS). VII. To determine whether baseline CBF or change in CBF are associated with PFS. VIII. To determine the association between standardized rCBV and PFS. EXPLORATORY OBJECTIVE: I. To measure the repeatability of normalized rCBV and standardized rCBV at baseline (pre-bevacizumab or biosimilar). OUTLINE: Patients undergo DSC-MRI within 3 days before bevacizumab initiation and in 12-25 days before their second bevacizumab infusion is given. After completion of study intervention, patients are followed up every 3 months for 5 years.
Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.
The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.