Status:
COMPLETED
EBV-Specific CTLs Following CD45 Antibody to Patients With Epstein-Barr Virus (EBV) + Nasopharyngeal Carcinoma (NPC)
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
The Methodist Hospital Research Institute
Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions:
Nasopharyngeal Cancer
EBV Infections
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
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, pe...
Detailed Description
Three different doses of CTL will be evaluated: dose level I: 2 x 10e7/m2; dose level II: 5 x 10e7/m2; dose level III: 1 x 10e8/m2 Day 1 YTH 24/54 800ug/kg over 8 hr; Day 2 YTH 24/54 800ug/kg over 8 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- .
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00078546
Start Date
September 1 2003
End Date
April 1 2007
Last Update
July 30 2012
Active Locations (2)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030
2
The Methodist Hospital
Houston, Texas, United States, 77030