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

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ClinicalTrials.gov Identifier: NCT03115333
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : December 8, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Brief 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.

Condition or disease Intervention/treatment Phase
Gliosarcoma Recurrent Glioblastoma Procedure: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine whether binary changes (increase versus [vs.] decrease) in rCBV within enhancing tumor from baseline to 2 weeks after initiation of anti-angiogenic therapy is associated with overall survival (OS).

SECONDARY OBJECTIVES:

I. To determine whether the baseline pre-treatment rCBV measure alone is associated with OS.

II. To determine whether binary changes (increase vs. decrease) in rCBV within enhancing tumor from baseline to 2 weeks after initiation of anti-angiogenic therapy is associated with progression-free survival (PFS).

III. To determine whether changes in rCBV as a continuous variable within enhancing tumor from baseline to 2 weeks after initiation of anti-angiogenic therapy is associated with OS or PFS.

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

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

OUTLINE:

Patients undergo DSC-MRI within 3 days before bevacizumab initiation and at day 15.

After completion of study intervention, patients are followed up every 3 months for 1 year and then every 6 months for up to 4 years.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Change in Relative Cerebral Blood Volume as a Biomarker for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma
Actual Study Start Date : April 14, 2017
Estimated Primary Completion Date : May 7, 2022
Estimated Study Completion Date : May 7, 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: Diagnostic (DSC-MRI)
Patients undergo DSC-MRI within 3 days before bevacizumab initiation and at day 15.
Procedure: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
Undergo DSC-MRI
Other Names:
  • DSC-MRI
  • Dynamic Susceptibility Contrast-Enhanced MRI
  • DYNAMIC SUSCEPTIBILITY-CONTRAST MRI




Primary Outcome Measures :
  1. Change in rCBV within enhancing tumor [ Time Frame: Baseline to 2 weeks ]
    Will determine whether binary changes (increase vs. decrease) in rCBV is associated with OS. Kaplan-Meier survival curves will be generated for both the increased and the decreased rCBV groups. The median survival time of both groups will be estimated and compared with a two-sided log rank test. Univariate Cox proportional hazards model will be used to test the association between changes in rCBV from baseline to 2 weeks and OS or PFS.

  2. OS [ Time Frame: Up to 5 years ]
    Will determine if binary changes (increase vs. decrease) in rCBV is associated with OS. The median survival time of both groups will be estimated and compared with a two-sided log rank test. Will determine whether changes in rCBV as a continuous variable within enhancing tumor from baseline to 2 weeks after initiation of anti-angiogenic therapy is associated with OS. Univariate Cox proportional hazards model will be used to test the association between changes in rCBV from baseline to 2 weeks and OS. The hazard ratio and its 95% confidence interval (CI) will be presented. Will determine the as


Secondary Outcome Measures :
  1. CBF [ Time Frame: Baseline ]
    Will determine if baseline CBF is associated with OS or PFS. Kaplan-Meier survival curves will be generated for both the increased and the decreased CBF groups, for either OS or PFS. The median survival time/progression free survival time of both groups will be estimated and compared with a two-sided log rank test. Univariate Cox proportional hazards model will be used to test the association between baseline CBF and OS or PFS. The hazard ratio and its 95% CI will be presented.

  2. Change in CBF [ Time Frame: Baseline to 2 weeks ]
    Will determine if changes in CBF is associated with OS or PFS. Kaplan-Meier survival curves will be generated for both the increased and the decreased CBF groups, for either OS or PFS. The median survival time/progression free survival time of both groups will be estimated and compared with a two-sided log rank test. The hazard ratio and its 95% CI will be presented.

  3. PFS [ Time Frame: Up to 5 years ]
    Will determine whether binary changes (increase vs. decrease) in rCBV within enhancing tumor from baseline to 2 weeks after initiation of anti-angiogenic therapy is associated with PFS. Will determine whether changes in rCBV as a continuous variable within enhancing tumor from baseline to 2 weeks after initiation of anti-angiogenic therapy is associated with PFS. Univariate Cox proportional hazards model will be used to test the association between changes in rCBV from baseline to 2 weeks and PFS. Kaplan-Meier survival curves will be generated for both the increased and the decreased rCBV grou

  4. rCBV [ Time Frame: Baseline ]
    Will determine whether the baseline pre-treatment rCBV measure alone is associated with OS. Univariate Cox proportional hazards model will be used to test the association between baseline rCBV and OS. The hazard ratio and its 95% confidence interval will be presented.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 >= 70
  • 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 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
  • Patient must not have been treated previously with immunotherapies (vaccines, checkpoint inhibitors, T-cells)
  • 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
  • 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
  • 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115333


Locations
United States, Arizona
Saint Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: Christopher Dardis    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Christopher Dardis         
United States, California
Eden Hospital Medical Center Recruiting
Castro Valley, California, United States, 94546
Contact: Stacy D. D'Andre    510-537-1234      
Principal Investigator: Stacy D. D'Andre         
UC Irvine Health/Chao Family Comprehensive Cancer Center Recruiting
Orange, California, United States, 92868
Contact: Daniel Chow    877-827-8839    ucstudy@uci.edu   
Principal Investigator: Daniel Chow         
United States, Florida
Baptist MD Anderson Cancer Center Recruiting
Jacksonville, Florida, United States, 32207
Contact: Robert Cavaliere    904-202-7051      
Principal Investigator: Robert Cavaliere         
United States, Georgia
Emory University Hospital/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Jeffrey J. Olson    404-778-1868      
Principal Investigator: Jeffrey J. Olson         
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Olivier Rixe    505-925-0366    LByatt@nmcca.org   
Principal Investigator: Olivier Rixe         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Jeffrey Crawford    888-275-3853      
Principal Investigator: Jeffrey Crawford         
United States, Pennsylvania
ECOG-ACRIN Cancer Research Group Recruiting
Philadelphia, Pennsylvania, United States, 19103
Contact: Jerrold L. Boxerman    401-444-1488      
Principal Investigator: Jerrold L. Boxerman         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Jerrold L. Boxerman    401-444-1488      
Principal Investigator: Jerrold L. Boxerman         
United States, Texas
University Hospital Recruiting
San Antonio, Texas, United States, 78229
Contact: Andrew J. Brenner    210-450-3800    CTO@uthscsa.edu   
Principal Investigator: Andrew J. Brenner         
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Andrew J. Brenner    210-450-3800    CTO@uthscsa.edu   
Principal Investigator: Andrew J. Brenner         
United States, Wisconsin
Froedtert and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Jennifer M. Connelly    414-805-4380      
Principal Investigator: Jennifer M. Connelly         
ProHealth D N Greenwald Center Recruiting
Mukwonago, Wisconsin, United States, 53149
Contact: Timothy R. Wassenaar    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Timothy R. Wassenaar         
ProHealth Oconomowoc Memorial Hospital Recruiting
Oconomowoc, Wisconsin, United States, 53066
Contact: Timothy R. Wassenaar    262-928-7878      
Principal Investigator: Timothy R. Wassenaar         
ProHealth Waukesha Memorial Hospital Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Timothy R. Wassenaar    262-928-7632      
Principal Investigator: Timothy R. Wassenaar         
UW Cancer Center at ProHealth Care Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Timothy R. Wassenaar    262-928-5539    Chanda.miller@phci.org   
Principal Investigator: Timothy R. Wassenaar         
Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jerrold Boxerman ECOG-ACRIN Cancer Research Group

Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT03115333     History of Changes
Other Study ID Numbers: EAF151
NCI-2016-01357 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
EAF151
EAF151 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
EAF151 ( Other Identifier: CTEP )
U10CA180820 ( U.S. NIH Grant/Contract )
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Glioblastoma
Gliosarcoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents