Nelfinavir for the Treatment of Gammaherpesvirus-Related Tumors

NCT02080416 | Terminated Early Phase 1 DMC

• 2 other identifiers: J13174NA_00092477
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Hodgkin Lymphoma; Hodgkin Lymphoma; Kaposi Sarcoma; Gastric Cancer; Nasopharyngeal Cancer; EBV; Castleman Disease

Keywords

EBV; KSHV; malignancy; lymphoma; sarcoma; virus-associated

Outcome Measures

Primary Outcomes (1)

• Lytic activation of viral gene expression by NFV

  To determine if NFV activates lytic gene expression in the tumors of patients with EBV(+) or KSHV(+) cancers, as evidenced by the ability to image the tumor with \[124I\]fialuridine-PET-CT.

  Day 4 and day 5 of Cycle 1

Secondary Outcomes (4)

• Serial assessment of methylation of viral DNA

  Day 4 of Cycle 1, at the end of cycles 1-4, 2 weeks post-treatment, and 4 weeks post-treatment

• Serial assessment of viral copy number in plasma

  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

  Every week up to 2 weeks post-treatment

• Tumor regression and response

  Within 2 weeks of ending treatment

Study Arms (1)

Nelfinavir

EXPERIMENTAL

Nelfinavir twice daily on days 1-14 of a 14-day cycle for 4 cycles

Drug: Nelfinavir

Interventions

Nelfinavir DRUG

Nelfinavir will be given 3000 mg orally twice daily on days 1-14 of a 14-day cycle. NFV will be continued in patients tolerating therapy for 4 cycles (8 weeks).

Also known as: Viracept®

Nelfinavir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Hodgkin Disease; Sarcoma, Kaposi; Stomach Neoplasms; Nasopharyngeal Neoplasms; Castleman Disease; Neoplasms; Lymphoma; Sarcoma

Interventions

Nelfinavir

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neoplasms, Connective and Soft Tissue; Neoplasms, Vascular Tissue; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Richard Ambinder, MD

  The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 6, 2014
• Study Start: July 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 10, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)