Nelfinavir for the Treatment of Gammaherpesvirus-Related Tumors

• Register: ClinicalTrials.gov
• Last refreshed on: 20 June 2016
• Main ID: NCT02080416
• Date of registration: 04/03/2014
• Prospective Registration: Yes
• Primary sponsor: Sidney Kimmel Comprehensive Cancer Center
• Public title: Nelfinavir for the Treatment of Gammaherpesvirus-Related Tumors
• Scientific title: A Pilot Trial of Nelfinavir for the Lytic Activation and Treatment of Gammaherpesvirus-Related Tumors
• Date of first enrolment: July 2014
• Target sample size: 1
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02080416
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 0

Countries of recruitment

United States

Contacts

• Name: Richard Ambinder, MD
• Affiliation: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Non-Hodgkin Lymphoma

Kaposi Sarcoma

Hodgkin Lymphoma

EBV

Castleman Disease

Nasopharyngeal Cancer

Gastric Cancer

Intervention(s)

Drug: Nelfinavir

Primary Outcome(s)

Lytic activation of viral gene expression by NFV [Time Frame: Day 4 and day 5 of Cycle 1]

Secondary Outcome(s)

Serial assessment of methylation of viral DNA [Time Frame: Day 4 of Cycle 1, at the end of cycles 1-4, 2 weeks post-treatment, and 4 weeks post-treatment]

Tolerability of high-dose nelfinavir [Time Frame: Every week up to 2 weeks post-treatment]

Tumor regression and response [Time Frame: Within 2 weeks of ending treatment]

Serial assessment of viral copy number in plasma [Time Frame: Day 4 of Cycle 1, at the end of cycles 1-4, 2 weeks post-treatment, and 4 weeks post-treatment]

Secondary ID(s)

NA_00092477

J13174

Source(s) of Monetary Support

Please refer to primary and secondary sponsors