Status:
COMPLETED
Carboplatin and Docetaxel Followed by Epstein-Barr Virus Cytotoxic T Lymphocytes
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 Carcinoma
Eligibility:
All Genders
10+ years
Phase:
PHASE2
Brief Summary
Patients have a type of cancer called nasopharyngeal carcinoma (NPC) that has either come back or not gone away after the best known standard treatments. Most patients that respond to chemotherapy on...
Detailed Description
A blood sample will be obtained to start making the CTLs before the patient begins chemotherapy. The patients EBV-specific T cells will be grown while the patient is being treated with chemotherapy an...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Nasopharyngeal Carcinoma in first or subsequent relapse or with primary refractory disease in whom the EBV-genome or antigens have been demonstrated in tissue biopsy samples
- Age 10 years or older
- Life expectancy of 8 weeks or more
- Karnofsky or Lansky score of 50 or more
- Normal bilirubin level (per institutional standard)
- AST and ALT 1.5 x or less upper limit of normal
- Alk Phos level less than 2.5 x upper limit of normal
- ANC greater than 1500 cells/ul
- Hgb 8.0 or greater
- Platelets 100,000 cells/ul or more
- Creatinine 2 x or less ULN or GFR 50 ml/min/1.73 m2 or more
- Women of child-bearing potential must take/use effective birth control while participating in the study.
- EXCLUSION CRITERIA:
- Due to the unknown effects of this therapy on a fetus, pregnant women will be excluded from this research.
- Prior allergic reaction to the study drugs used in this protocol or other drugs formulated with polysorbate 80.
- Known HIV positive subjects since treatment may be significantly immunosuppressive
- Women who are breast-feeding
- Severe intercurrent infection
- Patients, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Exclusion
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00953420
Start Date
November 1 2009
End Date
July 1 2015
Last Update
August 18 2017
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Houston Methodist Hospital
Houston, Texas, United States, 77030
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030
3
Texas Children's Hospital
Houston, Texas, United States, 77030