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Home > "A" Clinical Trials Conditions > Administration of EBV-Specific Cytotoxic T-Lymphocytes to Patients with EBV-Positive Cancer of the Nose and Throat  Administration of EBV-Specific Cytotoxic T-Lymphocytes to Patients with EBV-Positive Cancer of the Nose and Throat
Administration of EBV-Specific Cytotoxic T-Lymphocytes to Patients with EBV-Positive Cancer of the Nose and Throat
For Condition: Epstein-Barr Virus Infections,Nasopharyngeal Cancer
Status: Recruiting
Sponsor(s): Baylor College of Medicine , Texas Children's Hospital,The Methodist Hospital
Synopsis: Most patients with nasopharyngeal cancer (NPC) show evidence of infection with the virus that causes infectious mononucleosis, Epstein Barr virus (EBV) before or at the time of diagnosis of nasopharyngeal cancer. EBV is found in the cancer cells of most patients with nasopharyngeal cancer suggesting that it may play a role in causing this cancer. The cancer cells infected by EBV are able to hide from the body's immune system and escape destruction. We want to see if special white blood cells called T cells that have been trained to kill EBV infected cells can survive in your blood and affect the tumor.
Details: The primary objective of the study is to determine the safety of 2 IV injections of autologously derived EBV specific cytotoxic T-lymphocytes (CTLs). The following dose levels will be evaluated: - 2x10 7 cells/m2 - 1x10 8 cells/m2 - 2x 10 8 cells/m2 Three different dosing schedules will be evaluated. Three to six patients will be evaluated on each dosing schedule. Each patient will receive two injections, 14 days apart, according to the following dosing schedules: Group One - Day 0 - 2x10 7 cells/m2 - Day 14 - 2x10 7 cells/m2 Group Two - Day 0 - 2x10 7 cells/m2 - Day 14 - 1x10 8 cells/m2 Group Three - Day 0 - 1x10 8 cells/m2 - Day 14 - 2x 10 8 cells/m2 If patients with active disease have stable disease or a partial response by the RECIST criteria at their 8 week or subsequent evaluations, they are eligible to receive up to 6 additional doses of CTLs at monthly intervals, each of which will consist of the same cell number as their second injection. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second injection.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - All patients with NPC in first or subsequent relapse or with primary refractory disease or high risk (T3 or T4, or node positive disease) in whom the EBV genome or antigens have been demonstrated in tissue biopsies will be eligible for this trial. - Patients with a life expectancy >6 weeks - Patients with a Karnofsky score of >/= 50 - No severe intercurrent infection. - Patient, parent/guardian able to give informed consent. - Patients with bilirubin <2x normal, SGOT <3x normal, and Hgb >8.0 - Patients with a creatinine <2x normal for age - Patients should have been off other investigational therapy for one month prior to entry in this study. Exclusion criteria: - Patients with a life expectancy of <6 weeks. - Patients with a Karnofsky score of < 50. - Patients with a severe intercurrent infection. - Patient, parent/guardian unable to give informed consent. - Patients with a bilirubin >2x normal. SGOT >3x normal or abnormal prothrombin time. - Patients with a creatinine >2x normal for age - Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom. Note: Patients who would be excluded from the protocol strictly for laboratory abnormalities can be included at the investigators discretion after approval by the CAGT Protocol Review Committee and the FDA reviewer.
Total Enrollment: 18
Location and Contact Information:
Overall Study Official:
MalcolmBrenner, Study Chair, Baylor College of Medicine
Texas Children's Hospital *Recruiting*
Houston, Texas,
United States
Recruiting Helen Heslop 832-824-4662
The Methodist Hospital *Recruiting*
Houston, Texas,
United States
Recruiting Helen Heslop 832-824-4662
Additional Information:
Study ID Numbers: 9935; NPC
Study Start Date: June 2001
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074594
Other Epstein-Barr Virus Infections Studies:
1. Genetic Studies of Chronic Active Epstein-Barr Disease
2. Giving Epstein-Barr Virus (EBV) Specific Killer T Lymphocytes to Patients who have had Donor Marrow Grafts.
3. Treating Severe Chronic Epstein-Barr Virus (EBV) Infection with EBV Specific Cytotoxic T Lymphocytes (CTLs)
4. Protein Studies of the Epstein-Barr virus in Ethnically Diverse Populations
5. Administration of EBV-Specific Cytotoxic T-Lymphocytes to Patients with EBV-Positive Cancer of the Nose and Throat
Related Studies:
Other Epstein-Barr Virus Infections Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Administration of EBV-Specific Cytotoxic T-Lymphocytes to Patients with EBV-Positive Cancer of the Nose and Throat
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