Nelfinavir for the Treatment of Gammaherpesvirus-Related Tumors

• Status: Terminated
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The goals of this study is to determine if nelfinavir can target Epstein-Barr virus (EBV) and Kaposi sarcoma-associated herpesvirus (KSHV) in patients with certain cancers.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Treatments: Nelfinavir

Criteria

Inclusion Criteria:

• Age 18 years or older

• Biopsy proven EBV(+) or KSHV(+) malignancy

• Relapsed/refractory disease failing > 2 prior therapies

• Measurable, non-bony disease (at least one lesion on radiographic or physical exam assessment measuring > 2 cm in longest axis)

• KS patients with skin-only disease must have cutaneous lesions amenable to four 3 mm punch biopsies during the course of the study

• Eastern Cooperative Oncology Group (ECOG) performance status < 2

• Life expectancy of greater than 12 weeks

• Patients must be able to lie flat for at least 60 minutes and fit on a PET-CT scanner

• Ability to comply with an oral drug regimen

• Females of childbearing potential must have a negative pregnancy test at screening

• Patients must have normal organ and marrow function as defined below within 14 days of study entry

Exclusion Criteria:

• Patients with HIV-associated primary central nervous system lymphoma

• Radiotherapy or chemotherapy ending within 14 days of study enrollment

• Patients currently on other protease inhibitors

• Chronic diarrhea

• Acute, active infection within 14 days of enrollment

• Patients on active treatment for hypo- or hyperthyroidism

• End-stage liver disease unrelated to tumor

• Hepatitis B or hepatitis C infection

• Use of any other type of investigational agent or treatment concurrently or within 28 days before the first dose of study treatment

• History of iodine hypersensitivity

• Females who are pregnant or breastfeeding

• Physical or psychiatric conditions that in the estimation of the investigator place the patient at high risk of toxicity, non-compliance, or inability to complete the study requirements

• Use of drugs to treat or prevent herpesvirus infections

• Essential medication that is known to interact with nelfinavir