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A Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)

Primary Purpose

Glioblastoma Multiforme

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Fludarabine
Cyclophosphamide
CMV Specific Cytotoxic T Lymphocytes (CTL)
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring Glioblastoma multiforme, GBM, Cytomegalovirus, CMV, Cytotoxic T lymphocyte, CTL

Eligibility Criteria

5 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

FOR SCREENING

  • Patients must have a histopathologic diagnosis of GBM.
  • Patients from 5 to 65 years of age with GBM.

FOR TREATMENT

  • GBM has progressed following primary therapy.
  • Tumor is CMV pp65 or IE1 positive by immunohistochemistry (IHC).
  • Subjects must have pulse oximetry > or = 94 % on no supplemental oxygen.
  • Creatinine clearance must be > 50 cc/min as estimated by patient's serum creatinine, weight, and age.
  • Bilirubin must be < 2.0 mg/dl and SGOT/SGPT < 2.5 X normal.
  • ECOG performance status must be < or = 2, and for patients <16 years of age, Lansky performance status must be > or = 70%.

Exclusion Criteria:

  • Pregnant females
  • Subjects who are moribund or who because of cardiac, pulmonary, renal, hepatic or neurologic dysfunction are not expected to survive one month following the T cell infusion

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    GBM Treatment

    Arm Description

    Outcomes

    Primary Outcome Measures

    To determine the incidence of tumor responses, as defined as stable disease, partial, or complete responses after the infusion of CMV CTL.

    Secondary Outcome Measures

    To determine the duration and magnitude of donor chimerism post infusion by micro chimerism assays.
    To determine the incidence of increases in CMV pp65 or IE-1 T cells post infusion of allogeneic CMV CTL of GBM patients.
    To determine safety of allogeneic CTL infusions in this patient population.

    Full Information

    First Posted
    October 5, 2009
    Last Updated
    April 30, 2018
    Sponsor
    Milton S. Hershey Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00990496
    Brief Title
    A Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)
    Official Title
    A Phase I-II Study of Allogeneic CMV Specific Cytotoxic T Lymphocytes (CTL) for Patients With Refractory Glioblastoma Multiforme (GBM)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    Accrual goals not met
    Study Start Date
    September 2009 (undefined)
    Primary Completion Date
    October 28, 2010 (Actual)
    Study Completion Date
    October 28, 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Milton S. Hershey Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The primary purpose of this study is to determine the safety and efficacy of the infusion of partially matched, allogeneic, CMV specific cytotoxic T cells (CTL) for patients with GBM that have failed primary therapy.
    Detailed Description
    Tumor specimens of consenting patients will be tested by immunohistochemistry (IHC) for the presence of IE-1 and/or pp65. Subjects whose tumors test positive for either or both CMV antigens will be consented for the treatment phase which will include a regimen of fludarabine and cyclophosphamide daily for two days, cyclophosphamide only for a third day, followed by one day of rest prior to the day of CTL infusion. This trial intended to be a Phase 1/2 trial, but it never progressed to Phase 2 before termination.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glioblastoma Multiforme
    Keywords
    Glioblastoma multiforme, GBM, Cytomegalovirus, CMV, Cytotoxic T lymphocyte, CTL

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    GBM Treatment
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Fludarabine
    Intervention Description
    30 mg/m2
    Intervention Type
    Drug
    Intervention Name(s)
    Cyclophosphamide
    Intervention Description
    600 mg/m2
    Intervention Type
    Biological
    Intervention Name(s)
    CMV Specific Cytotoxic T Lymphocytes (CTL)
    Intervention Description
    CTL Infusion (3 - 5 x 10E6 cells/kg)
    Primary Outcome Measure Information:
    Title
    To determine the incidence of tumor responses, as defined as stable disease, partial, or complete responses after the infusion of CMV CTL.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    To determine the duration and magnitude of donor chimerism post infusion by micro chimerism assays.
    Time Frame
    2 years
    Title
    To determine the incidence of increases in CMV pp65 or IE-1 T cells post infusion of allogeneic CMV CTL of GBM patients.
    Time Frame
    2 years
    Title
    To determine safety of allogeneic CTL infusions in this patient population.
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: FOR SCREENING Patients must have a histopathologic diagnosis of GBM. Patients from 5 to 65 years of age with GBM. FOR TREATMENT GBM has progressed following primary therapy. Tumor is CMV pp65 or IE1 positive by immunohistochemistry (IHC). Subjects must have pulse oximetry > or = 94 % on no supplemental oxygen. Creatinine clearance must be > 50 cc/min as estimated by patient's serum creatinine, weight, and age. Bilirubin must be < 2.0 mg/dl and SGOT/SGPT < 2.5 X normal. ECOG performance status must be < or = 2, and for patients <16 years of age, Lansky performance status must be > or = 70%. Exclusion Criteria: Pregnant females Subjects who are moribund or who because of cardiac, pulmonary, renal, hepatic or neurologic dysfunction are not expected to survive one month following the T cell infusion
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kenneth Lucas G. Lucas, MD
    Organizational Affiliation
    Milton S. Hershey Medical Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    A Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)

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