NCT04169763

Nelfinavir, Cisplatin, and External Beam Radiation Therapy for the Treatment of Locally Advanced Vulvar Cancer That Cannot Be Removed by Surgery

A Phase I Study of Nelfinavir and Cisplatin Chemotherapy Concurrent With Pelvic Radiation for Locally Advanced Vulvar Cancer Not Amenable to Surgical Resection

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of nelfinavir when given together with cisplatin and external beam radiation therapy in treating patients with vulvar cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery. Nelfinavir is an antiviral drug normally used to treat human immunodeficiency virus (HIV). Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving nelfinavir, cisplatin, and external beam radiation therapy may work better than giving only cisplatin and external beam radiation therapy in treating patients with vulvar cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety and dose limiting toxicities of nelfinavir in combination with cisplatin plus inguinal +/-pelvic radiation therapy for treatment of patients with unresectable T2-4, N0-3 vulvar carcinoma. II. To determine the recommended phase II dose of nelfinavir combined with chemoradiotherapy. SECONDARY OBJECTIVES: I. To determine recurrence site (local/distant), progression-free survival and overall survival. II. To determine the levels of Akt activity (and downstream effectors such as pGSK3, pEBP1) and p16INK4A in addition to the presence of human papilloma virus (HPV) 16 and 18, and E6/E7 ribonucleic acid (RNA) in vulvar biopsy specimens of patients at up to two(2) different time points (1. pre nelfinavir, pre-radiation, 2. while on nelfinavir, pre-radiation). OUTLINE: Patients receive nelfinavir orally (PO) twice daily (BID) for up to 8 weeks. Starting week 2, patients also receive cisplatin intravenously (IV) over 60-90 minutes once weekly during weeks 2-8. Patients undergo external beam radiation therapy (EBRT) for 5 consecutive days between weeks 2-8. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3-6 months for 1 year.

Conditions

• Stage II Vulvar Cancer AJCC v8
• Stage III Vulvar Cancer AJCC v8
• Stage IIIA Vulvar Cancer AJCC v8
• Stage IIIB Vulvar Cancer AJCC v8
• Stage IIIC Vulvar Cancer AJCC v8
• Stage IVA Vulvar Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Cisplatin	Given IV
RADIATION	External Beam Radiation Therapy	Undergo EBRT
DRUG	Nelfinavir	Given PO

Timeline

• Start date: 2020-08-07
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2019-11-20
• Last updated: 2025-10-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study