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

NCT04169763 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-05-20

No results posted yet for this study

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.

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

DRUG

Cisplatin

Given IV

RADIATION

External Beam Radiation Therapy

Undergo EBRT

DRUG

Nelfinavir

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Lilie L Lin · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-07
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04169763 on ClinicalTrials.gov