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HIV drug shows promise against Hard-to-Treat vulvar cancer

NCT ID NCT04169763

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests whether adding the HIV drug nelfinavir to standard chemotherapy (cisplatin) and radiation can safely treat advanced vulvar cancer that has spread and cannot be surgically removed. About 25 adults with stage II-IVA vulvar cancer will take part. The main goal is to find the best dose of nelfinavir and check for side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * All 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. Hematoxylin \& eosin (H \& E) stained slide showing documentation of the primary invasive cancer is required. All specimens of primary tumor require documentation of type * Absolute neutrophil count (ANC) \>= 1,500/microliter (performed within 28 days from signing consent form) * Platelet count \>= 100,000/microliter (performed within 28 days from signing consent form) * Creatinine \< 2.0 mg/dL (performed within 28 days from signing consent form) * Total bilirubin =\< 1.5 times normal (performed within 28 days from signing consent form) * Glutamic-oxaloacetic transaminase (SGOT) =\< 3 times normal (performed within 28 days from signing consent form) * Patients with an Eastern Cooperative Oncology Group/Gynecologic Oncology Group (ECOG/GOG) performance status of 0, 1, or 2 * Patients with ureteral obstruction must be treated with stent or nephrostomy tube * Patients must be consented within twelve (12) weeks of diagnosis or must be restaged * Patients of childbearing potential must use an effective form of birth control. "Patients receiving oral contraceptives should be instructed that alternate or additional contraceptive measures should be used during therapy with VIRACEPT." * Confirmed seronegative HIV status within 3 months of signing consent * Patients must have signed an approved informed consent and authorization permitting release of personal health information Exclusion Criteria: * Patients with stage T1N0 disease * Patients who have known metastases to other organs outside the radiation field at the time of the original clinical and surgical staging * Patients who have received previous pelvic or abdominal radiation, cytotoxic chemotherapy, or previous therapy of any kind for this malignancy * Patients with septicemia or severe infection * Patients who have circumstances that will not permit completion of this study or the required follow-up * Patients who are pregnant at the time of diagnosis and do not wish pregnancy termination prior to initiation of treatment * Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of radiation fields * Patients with other concomitant malignancies (with the exception of non-melanoma skin cancer), who had (or have) any evidence of other cancer present within the last 5 years * Patients with gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis) * Patients with poorly controlled diabetes mellitus despite medication * Patients taking anti-arrhythmic agents such as amiodarone, quinidine, rifampin, ergot derivatives such as ergotamine, St John's wort, human menopausal gonadotropin (HMG)-CoA reductase inhibitors such as lovastatin, neuroleptic such as pimozide, sedatives such as midazolam and triazolam among other CYP3A4 and CYP2C19 substrates * Patients with phenylketonuria * Patients with estimated glomerular filtration rate (eGFR) \< 30

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • M D Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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