Study Stopped
Accrual goals not met
A Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)
A Phase I-II Study of Allogeneic CMV Specific Cytotoxic T Lymphocytes (CTL) for Patients With Refractory Glioblastoma Multiforme (GBM)
2 other identifiers
interventional
25
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 5, 2009
CompletedFirst Posted
Study publicly available on registry
October 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2010
CompletedMay 2, 2018
April 1, 2018
1.2 years
October 5, 2009
April 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the incidence of tumor responses, as defined as stable disease, partial, or complete responses after the infusion of CMV CTL.
2 years
Secondary Outcomes (3)
To determine the duration and magnitude of donor chimerism post infusion by micro chimerism assays.
2 years
To determine the incidence of increases in CMV pp65 or IE-1 T cells post infusion of allogeneic CMV CTL of GBM patients.
2 years
To determine safety of allogeneic CTL infusions in this patient population.
2 years
Study Arms (1)
GBM Treatment
EXPERIMENTALInterventions
CTL Infusion (3 - 5 x 10E6 cells/kg)
Eligibility Criteria
You may qualify if:
- 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%.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kenneth Lucas G. Lucas, MD
Milton S. Hershey Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2009
First Posted
October 6, 2009
Study Start
September 1, 2009
Primary Completion
October 28, 2010
Study Completion
October 28, 2010
Last Updated
May 2, 2018
Record last verified: 2018-04