Clinical trial · Interventional
Nelfinavir for the Treatment of Gammaherpesvirus-Related Tumors
A Pilot Trial of Nelfinavir for the Lytic Activation and Treatment of Gammaherpesvirus-Related Tumors
NCT02080416CI-TRIAL-00022546terminatedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Very slow accrual; terminated to allow resources to be utilized more effectively on other studies. No data analysis completed, nor any conclusions reached.
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castleman Disease | — | UNRESOLVED | — |
| EBV | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Kaposi Sarcoma | Kaposi Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Nasopharyngeal Cancer | Malignant Nasopharyngeal Neoplasm | CURATED_EXACT | 0.92 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nelfinavir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nelfinavir
- description
- Nelfinavir twice daily on days 1-14 of a 14-day cycle for 4 cycles
- interventionNames
- Drug: Nelfinavir
Primary outcomes (1)
- measure
- Lytic activation of viral gene expression by NFV
- timeFrame
- Day 4 and day 5 of Cycle 1
- description
- 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.
Secondary outcomes (4)
- measure
- Serial assessment of methylation of viral DNA
- timeFrame
- Day 4 of Cycle 1, at the end of cycles 1-4, 2 weeks post-treatment, and 4 weeks post-treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.