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

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

Status

Closed

Cancer Type

Brain & Spinal Cord Tumor

Trial Phase

Phase II

Eligibility

18 Years and older, Male and Female

Study Type

Diagnostic

NCT ID

NCT03115333

Protocol IDs

EAF151 (primary)
NCI-2016-01357

Study Sponsor

ECOG-ACRIN Cancer Research Group

NCI Full Details

http://clinicaltrials.gov/show/NCT03115333

Summary

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.

Objectives

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.

Eligibility

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
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 patient’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

Treatment Sites in Georgia

Atlanta Cancer Care - Alpharetta

3400 C Old Milton Parkway
Suite 400
Alpharetta, GA 30005
770-777-1315
www.atlantacancercare.com

Doctors:

Colleen S. Austin MD
Silpa C. Reddy MD
Sreekanth C. Reddy MD
Ronald G. Steis MD

Atlanta Cancer Care - Conyers

1498 Klondike Road
Suite 106
Conyers, GA 30094
404-303-3355
www.atlantacancercare.com

Atlanta Cancer Care - Cumming

1505 Northside Boulevard
Suite 4600
Cumming, GA 30041
770-205-5292 x1041
www.atlantacancercare.com

Doctors:

Sreekanth C. Reddy MD
Ronald G. Steis MD
Amelia B. Zelnak MD
Kelly A. May MD

Atlanta Cancer Care - Decatur

2545 Lawrenceville Highway
Suite 300
Decatur, GA 30033
404-303-3355
www.atlantacancercare.com

Doctors:

Lijo Simpson MD

Atlanta Cancer Care - Stockbridge

7813 Spivey Station Boulevard
Suite 210
Jonesboro, GA 30236
678 466-2069
www.atlantacancercare.com

Doctors:

Gurinderjit K. Sidhu MD
Lijo Simpson MD

Atlanta Cancer Care - Tower

5670 Peachtree Dunwoody Road
Suite 1100
Atlanta, GA 30342
404-303-3355
www.atlantacancercare.com

Doctors:

Colleen S. Austin MD
Silpa C. Reddy MD
Sreekanth C. Reddy MD
Amelia B. Zelnak MD
Kelly A. May MD

Georgia Cancer Specialists - Athens

125 King Avenue
Suite 200
Athens, GA 30606
www.gacancer.com

Doctors:

Ranjana S. Bhargava MD
Priya Rudolph

Georgia Cancer Specialists - Canton

228 Riverstone Drive
Canton, GA 30114
www.gacancer.com

Doctors:

Louis Crain Garrot MD
Gena H. Volas-Redd MD
Lynn M. Zemsky MD

Georgia Cancer Specialists - CenterPointe

1100 Johnson Ferry Road
Suite 600
Sandy Springs, GA 30342
404-256-4777 ext 9242
www.gacancer.com

Doctors:

Rodolfo E. Bordoni MD
Nishan H. Fernando MD
Pradeep C. Jolly MD

Georgia Cancer Specialists - Kennestone

790 Church Street
Suite 335
Marietta, GA 30060
www.gacancer.com

Doctors:

Louis Crain Garrot MD
Gena H. Volas-Redd MD
Lynn M. Zemsky MD

Georgia Cancer Specialists - Macon-Coliseum

308 Coliseum Drive
Suite 120
Macon, GA 31217
478-745-6130 x8152
www.gacancer.com

Doctors:

Cheryl F. Jones MD
Premila Malhotra MD

Georgia Cancer Specialists - Stemmer

2712 Lawrenceville Highway
Decatur, GA 30033
770-496-5555
www.gacancer.com

Doctors:

Jayanthi Srinivasiah MD
Simbo O. Aduloju MD
Aaron R. Alizadeh MD
Kathleen E. Lambert MD

Northside Hospital Cancer Institute

1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

Study Coordinator:
404-303-3355

Doctors:

Rodolfo E. Bordoni MD
Louis Crain Garrot MD
Pradeep C. Jolly MD
Cheryl F. Jones MD
Gurinderjit K. Sidhu MD
Jayanthi Srinivasiah MD
Gena H. Volas-Redd MD
Amelia B. Zelnak MD
Simbo O. Aduloju MD
Premila Malhotra MD
Aaron R. Alizadeh MD
Kelly A. May MD
Ranjana S. Bhargava MD
Priya Rudolph
Kathleen E. Lambert MD
Tatyana Sklyar

Northside Hospital Cancer Institute - Forsyth

1200 Northside Forsyth Drive
Suite 140
Cumming, GA 30041
404-303-3355
www.northside.com

Winship Cancer Institute of Emory University

1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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