Brain Cancer

EAF151



DSC-MRI in Measuring Relative Cerebral Blood Volume for Early Response to Bevacizumab in Patients with Recurrent Glioblastoma

STATUS: Active


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 patientโ€™s 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 patientโ€™s 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
Status: ACTIVE
Contact: Site Public Contact

Saint Joseph's Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact

Scottsdale
Mayo Clinic in Arizona
Status: ACTIVE
Contact: Site Public Contact

Tucson
Banner University Medical Center - Tucson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: UACC-NCTN@uacc.arizona.edu

University of Arizona Cancer Center-North Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

CA
Castro Valley
Eden Hospital Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: hempell@sutterhealth.org

Loma Linda
Loma Linda University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Los Angeles
USC / Norris Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: ucstudy@uci.edu

Palo Alto
VA Palo Alto Health Care System
Status: ACTIVE
Contact: Site Public Contact

FL
Boca Raton
Boca Raton Regional Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Status: ACTIVE
Contact: Site Public Contact

Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Status: ACTIVE
Contact: Site Public Contact

Jacksonville
Baptist MD Anderson Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Mayo Clinic in Florida
Status: ACTIVE
Contact: Site Public Contact

Miami
Miami Cancer Institute
Status: ACTIVE
Contact: Site Public Contact

University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Tampa
Moffitt Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ClinicalTrials@moffitt.org

Moffitt Cancer Center - McKinley Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ClinicalTrials@moffitt.org

Moffitt Cancer Center-International Plaza
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ClinicalTrials@moffitt.org

GA
Atlanta
Emory University Hospital / Winship Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Northside Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ClinicalTrials@northside.com

Cumming
Northside Hospital-Forsyth
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicaltrials@northside.com

IN
Indianapolis
IU Health Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: iutrials@iu.edu

Indiana University / Melvin and Bren Simon Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: iutrials@iu.edu

KS
Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

Overland Park
University of Kansas Hospital-Indian Creek Campus
Status: ACTIVE
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

KY
Lexington
Baptist Health Lexington
Status: ACTIVE
Contact: Site Public Contact

MD
Baltimore
Maryland Proton Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Email: info@mdproton.com

University of Maryland / Greenebaum Cancer Center
Status: ACTIVE
Contact: Site Public Contact

MI
Detroit
Henry Ford Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CTOResearch@hfhs.org

MN
Coon Rapids
Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Site Public Contact

Saint Paul
Regions Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

United Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

MO
Columbia
University of Missouri - Ellis Fischel
Status: ACTIVE
Contact: Site Public Contact

Creve Coeur
Siteman Cancer Center at West County Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Saint Louis
Siteman Cancer Center-South County
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Washington University School of Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: info@siteman.wustl.edu

NC
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancerclinicaltrials@med.unc.edu

Charlotte
Carolinas Medical Center / Levine Cancer Institute
Status: ACTIVE
Contact: Site Public Contact

Durham
Duke University Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Greenville
East Carolina University
Status: ACTIVE
Contact: Site Public Contact
Email: eubankss@ecu.edu

Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE
Contact: Site Public Contact

NJ
Middletown
Memorial Sloan Kettering Monmouth
Status: ACTIVE
Contact: Site Public Contact

NM
Albuquerque
University of New Mexico Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: LByatt@nmcca.org

NY
Commack
Memorial Sloan Kettering Commack
Status: ACTIVE
Contact: Site Public Contact

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Uniondale
Memorial Sloan Kettering Nassau
Status: ACTIVE
Contact: Site Public Contact

West Harrison
Memorial Sloan Kettering Westchester
Status: ACTIVE
Contact: Site Public Contact

OH
Cincinnati
University of Cincinnati Cancer Center-UC Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancer@uchealth.com

OR
Portland
Oregon Health and Science University
Status: ACTIVE
Contact: Site Public Contact
Email: trials@ohsu.edu

PA
Pittsburgh
Allegheny General Hospital
Status: ACTIVE
Contact: Site Public Contact

RI
Providence
Rhode Island Hospital
Status: ACTIVE
Contact: Site Public Contact

TX
Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu

Houston
Memorial Hermann Texas Medical Center
Status: ACTIVE
Contact: Site Public Contact

San Antonio
University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: evelyn.swenson-britt@uhs-sa.com

University of Texas Health Science Center at San Antonio
Status: ACTIVE
Contact: Site Public Contact
Email: phoresearchoffice@uthscsa.edu

VA
Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CTOclinops@vcu.edu

WI
Menomonee Falls
Froedtert Menomonee Falls Hospital
Status: ACTIVE
Contact: Site Public Contact

Milwaukee
Aurora Saint Luke's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: ncorp@aurora.org

Medical College of Wisconsin
Status: ACTIVE
Contact: Site Public Contact

Mukwonago
ProHealth D N Greenwald Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research.institute@phci.org

Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Waukesha
ProHealth Waukesha Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

UW Cancer Center at ProHealth Care
Status: ACTIVE
Contact: Site Public Contact
Email: Chanda.miller@phci.org

West Bend
Froedtert West Bend Hospital / Kraemer Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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.


EAF151 Home Page
ECOG-ACRIN Cancer Research Group