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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cisplatin — DRUG
  Given IV
• External Beam Radiation Therapy — RADIATION
  Undergo EBRT
• Nelfinavir — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Aug 7, 2020

Status verified

May 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

25 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (nelfinavir, cisplatin, EBRT)
  Patients receive nelfinavir PO BID for up to 8 weeks. Starting week 2, patients also receive cisplatin IV over 60-90 minutes once weekly during weeks 2-8. Patients undergo EBRT for 5 consecutive days between weeks 2-8. Treatment continues in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Recommended phase II dose (RP2D) of nelfinavir [ Time Frame: 1 year ]

Central Contacts

• Lilie L Lin
  713-563-2300
  [email protected]

Locations (1)

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