ACTIVE_NOT_RECRUITING

DSC-MRI in Measuring rCBV for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma

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Conditions

GliosarcomaRecurrent Glioblastoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2017-07-25
Study Completion:2027-05-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03115333

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically proven intracranial glioblastoma or gliosarcoma at initial surgery
  2. * 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)
  3. * Karnofsky performance status \>= 70
  4. * Women must not be pregnant or breast-feeding
  5. * 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
  6. * Patient must not have been treated previously with immunotherapies (vaccines, checkpoint inhibitors, T-cells)
  7. * 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
  8. * 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
  9. * Patients must be able to tolerate brain MRI scans with dynamic intravenous gadolinium-based contrast agent injections
  10. * Ability to withstand 22 gauge intravenous (IV) placement
  11. * No history of untreatable claustrophobia
  12. * No magnetic resonance (MR) incompatible implants/devices or metallic foreign bodies
  13. * No contraindication to intravenous contrast administration
  14. * 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
  15. * 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
  16. * Weight compatible with limits imposed by the MRI scanner table
  17. * 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
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Jerrold Boxerman
PRINCIPAL_INVESTIGATOR
ECOG-ACRIN Cancer Research Group

Study Locations (Sites)

Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
United States
Mayo Clinic Hospital
Phoenix, Arizona, 85054
United States
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
United States
Eden Hospital Medical Center
Castro Valley, California, 94546
United States
Loma Linda University Medical Center
Loma Linda, California, 92354
United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
VA Palo Alto Health Care System
Palo Alto, California, 94304
United States
Boca Raton Regional Hospital
Boca Raton, Florida, 33486
United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States
Moffitt Cancer Center-International Plaza
Tampa, Florida, 33607
United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Northside Hospital
Atlanta, Georgia, 30342
United States
Northside Hospital-Forsyth
Cumming, Georgia, 30041
United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
United States
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
United States
Baptist Health Lexington
Lexington, Kentucky, 40503
United States
Maryland Proton Treatment Center
Baltimore, Maryland, 21201
United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Regions Hospital
Saint Paul, Minnesota, 55101
United States
United Hospital
Saint Paul, Minnesota, 55102
United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125
United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
United States
University of Missouri - Ellis Fischel
Columbia, Missouri, 65212
United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
United States
Washington University School of Medicine
St Louis, Missouri, 63110
United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129
United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102
United States
Memorial Sloan Kettering Commack
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
East Carolina University
Greenville, North Carolina, 27834
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio, 45219
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
United States
Memorial Hermann Texas Medical Center
Houston, Texas, 77030
United States
University Hospital
San Antonio, Texas, 78229
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051
United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149
United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066
United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188
United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188
United States
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095
United States

Collaborators and Investigators

Sponsor: ECOG-ACRIN Cancer Research Group

  • Jerrold Boxerman, PRINCIPAL_INVESTIGATOR, ECOG-ACRIN Cancer Research Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-07-25
Study Completion Date2027-05-07

Study Record Updates

Study Start Date2017-07-25
Study Completion Date2027-05-07

Terms related to this study

Additional Relevant MeSH Terms

  • Gliosarcoma
  • Recurrent Glioblastoma