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

Glioblastoma Multiforme Clinical Trial

Official title:

A Phase I-II Study of Allogeneic CMV Specific Cytotoxic T Lymphocytes (CTL) for Patients With Refractory Glioblastoma Multiforme (GBM)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00990496
• Other study ID #: 31717
• Secondary ID: PSHCI #09-045
• Status: Terminated
• Phase: Phase 1
• Start date: September 2009
• Est. completion date: October 28, 2010

Study information

• Verified date: April 2018
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: October 28, 2010
• Est. primary completion date: October 28, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Drug:
• Fludarabine
30 mg/m2
• Cyclophosphamide
600 mg/m2

Biological:
• CMV Specific Cytotoxic T Lymphocytes (CTL)
CTL Infusion (3 - 5 x 10E6 cells/kg)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To determine the duration and magnitude of donor chimerism post infusion by micro chimerism assays.		2 years
Secondary	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
Secondary	To determine safety of allogeneic CTL infusions in this patient population.		2 years