Gastric Cancer Clinical Trial
Official title:
A Pilot Trial of Nelfinavir for the Lytic Activation and Treatment of Gammaherpesvirus-Related Tumors
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | February 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Serial assessment of methylation of viral DNA | The methylation of viral DNA in plasma at baseline and during the course of NFV therapy and follow-up will be determined for each patient. | Day 4 of Cycle 1, at the end of cycles 1-4, 2 weeks post-treatment, and 4 weeks post-treatment | No |
Secondary | Serial assessment of viral copy number in plasma | Viral DNA copy number in plasma at baseline and during the course of NFV therapy and follow-up will be determined for each patient by quantitative polymerase chain reaction assay (qPCR). | Day 4 of Cycle 1, at the end of cycles 1-4, 2 weeks post-treatment, and 4 weeks post-treatment | No |
Secondary | Tolerability of high-dose nelfinavir | The tolerability of high-dose NFV in patients with relapsed/refractory EBV(+) or KSHV(+) tumors will be determined by evaluation of dose limiting toxicities (DLT). | Every week up to 2 weeks post-treatment | Yes |
Secondary | Tumor regression and response | The responses of EBV(+) and KSHV(+) tumors after 4 cycles of NFV therapy will be assessed by CT for solid tumors, CT or PET-CT for lymphomas and lymphoproliferative disorders, and skin exam with lesion measurements for KS. | Within 2 weeks of ending treatment | No |
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