Epstein-Barr Virus (EBV) Protocol Information
Protocol Title:
A Phase I/II Trial of Butyrate and Ganciclovir in Epstein-Barr Virus (EBV)-Associated Malignancies
Investigators:
Douglas V. Faller, Ph.D., M.D.
Susan P. Perrine, M.D.
Boston University School of Medicine
Cancer Research Center, Rm. K-701
715 Albany St., Boston, MA 02118 -2526
Ph:617-638-4173; FAX:617-638-4176
dfaller@bu.edu
sperrine@bu.edu
Steven J. Mentzer, M.D.
Brigham and Women’s Hospital
Ph: (617) 912-9487
sjmentzer@bics.bwh.harvard.edu
Richard O’Reilly, M.D. / Trudy Small, M.D.
Memorial Sloan Kettering Hospital
Oliver Hermine
Hospital Necker, Paris, France
Steven Horwitz, M.D.
Stanford University Medical Center
Principle:
EBV-associated tumors normally are not sensitive to anti-viral agents such as ganciclovir because they do no express viral TK. The drug arginine butyrate induces the TK gene in the EBV(+) tumors and makes them susceptible to ganciclovir.
FDA-Registered Phase I/II Study
Abbreviated Eligibility / Patient Selection:
4.1 EBV(+) neoplasm (immunohistochemistry and/or in situ hybridization)
4.3 Prior cytotoxic chemotherapy or radiotherapy NOT required
4.5 Granulocyte count > 1000; platelets > 50,000/mm3.
4.6 Bilirubin < 1.5mg/dl, serum aminotransferases <2 X normal, and serum creatinine <3.0 mg/dl
4.9 No limitations on functional status for eligibility
4.11 > one (1) year of age
Abbreviated Treatment Schedule:
On day -1, begin treatment with ganciclovir at standard doses (5 mg/kg IV over 1 hour, bid)
On day 0, infusion of arginine butyrate will begin
Level 1: 500 mg/kg/day IV (20.8 mg/kg/hr) for 2 days
Level 2: 1000 mg/kg/day IV (41.6 mg/kg/hr) for 2 days
Level 3: 1250 mg/kg/day IV (62.5 mg/kg/hr) as tolerated and continued until day 21
Results in Treatment of Lyphoproliferative Disease (LPD) so far:
75% CR, as assessed radiologically (but numbers still small).
If you wish to enroll a patient, please contact Drs. Faller or Perrine
EBV Adult Informed Consent Form