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Alkylating Agent

Nelfinavir + Chemoradiation for Vulvar Cancer

Phase 1
Recruiting
Led By Lilie L Lin
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with primary, previously untreated, histologically confirmed invasive carcinoma of the vulva (any cell type) not amenable to surgical excision, clinical stages T2-T4, N0-3, M0
Patients with an Eastern Cooperative Oncology Group/Gynecologic Oncology Group (ECOG/GOG) performance status of 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing nelfinavir, an antiviral drug, in combination with cisplatin and external beam radiation therapy to treat patients with vulvar cancer that has spread to nearby tissue or lymph nodes.

Who is the study for?
This trial is for patients with locally advanced vulvar cancer that can't be surgically removed. Eligible participants have not had prior treatment, are in good enough health to undergo therapy (ECOG/GOG status 0-2), and have proper organ function. They must not be pregnant, HIV positive, or have other conditions like severe infections or diabetes that aren't well-managed.Check my eligibility
What is being tested?
The study is testing the combination of nelfinavir (an antiviral drug), cisplatin (a chemotherapy drug), and external beam radiation therapy to see if they're more effective together than just cisplatin and radiation alone for treating vulvar cancer.See study design
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, vomiting, kidney damage from cisplatin; skin irritation from radiation; and possible liver issues or digestive problems from nelfinavir.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My vulvar cancer is confirmed, not surgically removable, and at a certain stage.
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I can take care of myself but may not be able to do heavy physical work.
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I have a tube or stent for my blocked ureter.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Recommended phase II dose (RP2D) of nelfinavir
Secondary outcome measures
Overall survival
Progression-free survival

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (nelfinavir, cisplatin, EBRT)Experimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nelfinavir
FDA approved
External Beam Radiation Therapy
2006
Completed Phase 3
~3070
Platinum
Not yet FDA approved

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,377 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,347 Total Patients Enrolled
Lilie L LinPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
654 Total Patients Enrolled

Media Library

Cisplatin (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04169763 — Phase 1
Vulvar Cancer Research Study Groups: Treatment (nelfinavir, cisplatin, EBRT)
Vulvar Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT04169763 — Phase 1
Cisplatin (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04169763 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the typical medical applications of Nelfinavir?

"Nelfinavir is a popular drug used to treat human immunodeficiency virus type 1 (hiv-1) infection. It also has been noted as effective in treating advanced ovarian cancer that resists standard treatments, and neoplasm metastasis."

Answered by AI

Can you enlighten me as to any antecedent studies involving Nelfinavir?

"At the present moment, 749 clinical trials are underway to investigate Nelfinavir. Of those studies, 289 have progressed to Phase 3 testing. Although many of these experiments take place in Shanghai, there are also 44135 other sites conducting research on this drug."

Answered by AI

What risks are posed by the utilization of Nelfinavir?

"Our specialists at Power gave Nelfinavir a grade of 1 due to being in Phase 1; minimal evidence exists regarding its safety and effectiveness."

Answered by AI

Are they currently enrolling participants for this scientific experiment?

"Affirmative. The clinicaltrial.gov registry discloses that this research is currently recruiting subjects, with the inaugural post date of August 7th 2020 and a recent update on September 18th 2020. A total of eighteen volunteers are necessary for participation at only one site."

Answered by AI

How many individuals have been approved to participate in this clinical trial?

"Affirmative. According to clinicaltrials.gov, the medical study is currently recruiting participants which was first listed on August 7th 2020 and last modified on September 18th 2020. The research requires 18 individuals from 1 centre."

Answered by AI
~8 spots leftby Dec 2026