RecruitingPhase 1NCT04169763

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

25 participants

Start Date

Aug 7, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding nelfinavir (an antiviral drug) to standard chemotherapy and radiation improves treatment for vulvar cancer that cannot be removed surgically. **You may be eligible if...** - You have a confirmed diagnosis of invasive vulvar cancer that cannot be surgically removed - Your cancer is stage T2–T4 (locally advanced) - You have adequate blood counts, kidney, and liver function - You have not had prior radiation to the pelvis for this cancer **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You have serious infections (e.g., active hepatitis, HIV with low CD4 count) - You are pregnant or breastfeeding - You have severe neuropathy (nerve damage) or uncontrolled diabetes - You are taking certain medications that interact with nelfinavir Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCisplatin

Given IV

RADIATIONExternal Beam Radiation Therapy

Undergo EBRT

DRUGNelfinavir

Given PO


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT04169763