A Pilot Trial of Nelfinavir for the Lytic Activation and Treatment of Gammaherpesvirus-Related Tumors
This is a pilot trial to determine if nelfinavir can induce lytic viral gene expression in patients with EBV-associated or KSHV-associated tumors.
â?¢ Age 18 years or older â?¢ Biopsy proven EBV(+) or KSHV(+) malignancy, including but not limited to: a. EBV(+) non-Hodgkin lymphoma or lymphoproliferative disease b. EBV(+) Hodgkin lymphoma c. KSHV(+) Kaposi sarcoma involving skin, with or without organ involvement d. KSHV(+) primary effusion lymphoma e. EBV(+) gastric cancer f. EBV(+) nasopharyngeal cancer g. EBV(+) leimyosarcoma h. KSHV(+) Castleman disease i. Chronic active EBV â?¢ Relapsed/refractory disease failing greater than 2 prior therapies. An exception is patients with KS, where patients can be previously untreated, relapsed/refractory to one or more prior therapies, or intolerant of a prior therapy. â?¢ Measurable disease, as demonstrated by imaging or physical exam performed less than 28 days of study entry, provided no anti-tumor therapies or interventions have occurred in that time period. â?¢ KS patients with skin-only disease must have cutaneous lesions amenable to four 3 mm punch biopsies during the course of the study (either four separate lesions measuring greater than 4 mm each OR two separate lesions measuring greater than 8 mm each). â?¢ Eastern Cooperative Oncology Group (ECOG) performance status less than 2 â?¢ Life expectancy of greater than 12 weeks â?¢ Patients must be able to lie flat for at least 60 minutes and fit on a PET-CT scanner â?¢ Ability to comply with an oral drug regimen â?¢ Ability and willingness to give informed consent and ability to return to the study clinic during the study period â?¢ Females of childbearing potential must have a negative pregnancy test at screening and prior to imaging â?¢ Patients must have normal organ and marrow function
09/16/2014 04:03 AM