10 patients have been enrolled on the study. 2 of the patients entered on trial were inevaluable. An end of study biopsy was not possible on one patient and another was found to have an EBV negative tumor upon re-evaluation. Two patients experienced adverse events while on study. Patient 002 had a history of hypertension and mild angina-like symptoms. On day 2 of cycle 1 (12-17-97), the patient became hypotensive and quickly recovered. Several hours later he developed angina symptoms that had ECG changes including significant Q waves in inferior leads. Cardiac enzymes were normal and the patient was well otherwise. Patient 002 did not receive any further treatment after this event. Patient 005 received his first cycle of therapy March 2nd, 1998 through 8th, 1998 and tolerated treatment well. A post-treatment biopsy was done on March 9th, 1998 (within 72 hours of completion of the study drug infusion). The patient was admitted to the Prince of Wales Hospital on March 11th for anemia secondary to epistaxis. The patient was transfused three units of packed red blood cells, and discharged without incident. The patient returned for follow-up post-discharge on March 17th, 1998. At this visit the patient had a stable hemoglobin and platelet count. A repeat CT was done on March 25th, 1998, showing static disease. On March 27th, 1998, the patient expired with nasopharyndeal hemorrhage, a common complication of nasoparyngeal carcinoma. The JCCI was made aware of the 2 cases in which adverse reactions were reported during or after completion of therapy.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000052-38S2
Application #
6264066
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
38
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Johns Hopkins University
Department
Type
DUNS #
045911138
City
Baltimore
State
MD
Country
United States
Zip Code
21218
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