EBV-Specific CTLs Following CD45 Antibody to Patients With Epstein-Barr Virus (EBV) + Nasopharyngeal Carcinoma (NPC)
Completed · Phase 1
Conditions studied: Nasopharyngeal Cancer, EBV Infections
In brief
To determine the safety of the combination of CD45 monoclonal antibody (Mab) followed by intravenous injection of EBV specific CTL in patients with nasopharyngeal cancer. To compare the expansion, persistence and anti-tumor effects of the EBV specific CTL given after CD45 Mab administration with that observed in our first study. To obtain preliminary information on the safety and response to an extended dosage regimen of EBV-specific CTL in patients, who have stable disease or a partial response after the initial dose of EBV-specific CTL.
Key facts
- Study ID
- NCT00078546
- Run by
- Baylor College of Medicine
- People needed
- 12
- Starts
- 2003-09-01
- Expected to finish
- 2007-04-01
- Last updated by the study team
- 2012-07-30
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Any patient with EBV positive NPC, in relapse or with primary resistant disease
- Life expectancy of more than 6 weeks.
- No severe intercurrent infection
- Patient, parent/guardian able to give informed consent
- Bilirubin less than 2x normal
- SGOT less than 3x normal,
- Hgb higher than 8.0 g/L
- Creatinine less than 2x normal for age
- Patients should have been off other investigational therapy for one month prior to entry in this study.
- Karnofsky score of over or equal to 50.
You may not qualify if…
- 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 investigator's discretion after approval by the CCGT Protocol Review Committee and the FDA reviewer.
Where it is running
- Texas Children's Hospital — Houston, Texas, United States
- The Methodist Hospital — Houston, Texas, United States
Full record on ClinicalTrials.gov
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