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

NCT03115333

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.

Related Conditions:
  • Glioblastoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: DSC-MRI in Measuring Relative Cerebral Blood Volume for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma
  • Official Title: Change in Relative Cerebral Blood Volume as a Biomarker for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma

Clinical Trial IDs

  • ORG STUDY ID: EAF151
  • SECONDARY ID: NCI-2016-01357
  • SECONDARY ID: EAF151
  • SECONDARY ID: EAF151
  • SECONDARY ID: EAF151
  • SECONDARY ID: U10CA180820
  • NCT ID: NCT03115333

Conditions

  • Gliosarcoma
  • Recurrent Glioblastoma

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Diagnostic (DSC-MRI)ExperimentalPatients undergo DSC-MRI within 3 days before bevacizumab initiation and at day 15.

    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 >= 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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Change in rCBV within enhancing tumor
    Time Frame:Baseline to 2 weeks
    Safety Issue:
    Description: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.

    Secondary Outcome Measures

    Measure:CBF
    Time Frame:Baseline
    Safety Issue:
    Description: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.
    Measure:Change in CBF
    Time Frame:Baseline to 2 weeks
    Safety Issue:
    Description: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.
    Measure:PFS
    Time Frame:Up to 5 years
    Safety Issue:
    Description: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
    Measure:rCBV
    Time Frame:Baseline
    Safety Issue:
    Description: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.

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:ECOG-ACRIN Cancer Research Group

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