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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 5 Years - 65 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00990496
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Milton S. Hershey Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Kenneth Lucas G. Lucas, MD
Principal Investigator Affiliation Milton S. Hershey Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Terminated
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme
Additional Details

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.

Arms & Interventions

Arms

Experimental: GBM Treatment

Interventions

Drug: - Fludarabine

30 mg/m2

Drug: - Cyclophosphamide

600 mg/m2

Biological: - CMV Specific Cytotoxic T Lymphocytes (CTL)

CTL Infusion (3 - 5 x 10E6 cells/kg)

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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