Nelfinavir for the Treatment of Gammaherpesvirus-Related Tumors

Stopped early · Early Phase 1

Conditions studied: Non-Hodgkin Lymphoma, Hodgkin Lymphoma, Kaposi Sarcoma, Gastric Cancer, Nasopharyngeal Cancer, EBV, Castleman Disease

In brief

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.

Key facts

Study ID

NCT02080416

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

1

Starts

2014-07-01

Expected to finish

2016-02-01

Last updated by the study team

2016-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.