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

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Status: Active

Description

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 patient’s response to treatment.

Eligibility 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 >= 60
  • 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 administer bevacizumab, either as single therapy or in conjunction with other chemotherapeutic regimens, in order to treat tumor progression/recurrence per the treating physician; patients receiving bevacizumab primarily for reduction of edema (i.e. alleviation of symptoms) rather than for tumor treatment are excluded
  • Patients who have not previously received a bevacizumab-containing regimen (i.e., this must be the first bevacizumab-containing therapy administered to the patient)
  • Patient must not have planned treatment with immunotherapies (vaccines, checkpoint inhibitors, T-cells); if the patient’s most recent recurrence occurs while on immunotherapy, this must be judged as true recurrence using Immunotherapy Response Assessment in Neuro-Oncology (iRANO) criteria
  • 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; 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
  • Patient must be cleared for bevacizumab administration 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 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 bevacizumab containing chemotherapy regimen; patient can be treated with bevacizumab alone or in combination with other chemotherapies; patient may also be receiving treatment with Optune

Locations & Contacts

Arizona

Phoenix
Saint Joseph's Hospital and Medical Center
Status: Active
Contact: Christopher Dardis
Phone: 888-823-5923 Email: ctsucontact@westat.com

California

Castro Valley
Eden Hospital Medical Center
Status: Active
Contact: Stacy D. D'Andre
Phone: 510-537-1234
Loma Linda
Loma Linda University Medical Center
Status: Active
Contact: Muhammad Omair Kamal
Phone: 909-558-3375
Los Angeles
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Mark Susumu Shiroishi
Phone: 323-865-0451
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: Active
Contact: Daniel Chow
Phone: 877-827-8839 Email: ucstudy@uci.edu

Florida

Boca Raton
Boca Raton Regional Hospital
Status: Active
Contact: Sajeel Akbar Chowdhary
Phone: 561-955-4800
Jacksonville
Baptist MD Anderson Cancer Center
Status: Active
Contact: Robert Cavaliere
Phone: 904-202-7051

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Contact: Jeffrey J. Olson
Phone: 404-778-1868

Kentucky

Lexington
Baptist Health Lexington
Status: Active
Contact: Arvinda Padmanabhan
Phone: 859-260-6425

Michigan

Detroit
Henry Ford Hospital
Status: Active
Contact: Ding Wang
Phone: 313-916-1784

Minnesota

Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: Temporarily closed to accrual
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Rochester
Mayo Clinic
Status: Active
Contact: Timothy J. Kaufmann
Phone: 855-776-0015
Saint Paul
United Hospital
Status: Active
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: Active
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: Active
Contact: Olivier Rixe
Phone: 505-925-0366 Email: LByatt@nmcca.org

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Contact: Yueh Lee
Phone: 877-668-0683 Email: cancerclinicaltrials@med.unc.edu
Charlotte
Carolinas Medical Center / Levine Cancer Institute
Status: Active
Contact: Ashley Love Sumrall
Phone: 704-355-2884
Durham
Duke University Medical Center
Status: Active
Contact: Jeffrey Crawford
Phone: 888-275-3853

Pennsylvania

Philadelphia
ECOG-ACRIN Cancer Research Group
Status: Active
Contact: Jerrold L. Boxerman
Phone: 401-444-1488

Rhode Island

Providence
Rhode Island Hospital
Status: Active
Contact: Jerrold L. Boxerman
Phone: 401-444-1488

Texas

San Antonio
University Hospital
Status: Active
Contact: Andrew Jacob Brenner
Phone: 210-450-3800 Email: CTO@uthscsa.edu
University of Texas Health Science Center at San Antonio
Status: Active
Contact: Andrew Jacob Brenner
Phone: 210-450-3800 Email: CTO@uthscsa.edu

Wisconsin

Menomonee Falls
Community Memorial Hospital
Status: Active
Contact: Jennifer M. Connelly
Phone: 262-257-5100
Milwaukee
Froedtert and the Medical College of Wisconsin
Status: Active
Contact: Jennifer M. Connelly
Phone: 414-805-4380
Mukwonago
ProHealth D N Greenwald Center
Status: Active
Contact: Timothy Robert Wassenaar
Phone: 888-823-5923 Email: ctsucontact@westat.com
Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Status: Active
Contact: Timothy Robert Wassenaar
Phone: 262-928-7878
Waukesha
ProHealth Waukesha Memorial Hospital
Status: Active
Contact: Timothy Robert Wassenaar
Phone: 262-928-7632
UW Cancer Center at ProHealth Care
Status: Active
Contact: Timothy Robert Wassenaar
Phone: 262-928-5539 Email: Chanda.miller@phci.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

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).

SECONDARY OBJECTIVES:

I. To determine whether the baseline S0 normalized rCBV measure alone is associated with OS.

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

III. To determine whether changes in normalized rCBV as a continuous variable within enhancing tumor from baseline (S0) to post-dose 1 treatment scan (S1) is associated with OS or PFS.

IV. To determine the association between normalized rCBV and OS when adjusting for changes in enhancing tumor volume.

V. To determine whether baseline cerebral blood flow (CBF) or changes in CBF are associated with OS or PFS.

VI. To determine the association between standardized rCBV and PFS or OS.

EXPLORATORY OBJECTIVES:

I. To measure the repeatability of normalized CBV and standardized CBV at baseline (pre-bevacizumab).

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.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Diagnostic

Lead Organization

Lead Organization
ECOG-ACRIN Cancer Research Group

Principal Investigator
Jerrold L. Boxerman

Trial IDs

Primary ID EAF151
Secondary IDs NCI-2016-01357
Clinicaltrials.gov ID NCT03115333