Status:
COMPLETED
T-Lymphocytes in Treating Patients With Epstein-Barr Virus-Positive Nasopharyngeal Cancer, 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:
Head and Neck Cancer
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
Patients have a type of cancer called nasopharyngeal cancer. This cancer has come back or not gone away or is at high risk for coming back after treatment (including the best treatment we know for nas...
Detailed Description
We will first test a biopsy of the tumor (that has already been done) to see if your tumor cells are EBV positive. If the patient is eligible, we will then take 60-70 ml (12-14 teaspoons) of blood fro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00609219
Start Date
August 1 2001
End Date
June 1 2012
Last Update
October 10 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