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Nelfinavir, Cisplatin, and Radiation for Advanced Vulvar Cancer

This study is looking at the side effects and best dose of nelfinavir when given with cisplatin and external beam radiation therapy for locally advanced vulvar cancer that cannot be removed by surgery. Nelfinavir is an antiviral drug that may help stop tumor cells from growing. Cisplatin is a chemotherapy drug that also works to stop cancer cell growth, and radiation therapy uses high-energy beams to kill tumor cells. This study is for patients aged 18 and older with specific stages of vulvar cancer (Stage II, IIIA, IIIB, IIIC) that has not been previously treated and cannot be surgically removed. The main goals are to find a safe dose of nelfinavir and to track any side effects over one year. The study plans to enroll 25 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 25 participants.
What's involved
You would take nelfinavir by mouth twice daily for up to 8 weeks. Starting in week 2, you would also receive cisplatin intravenously (IV) once weekly for 7 weeks and undergo external beam radiation therapy for 5 consecutive days each week for 7 weeks.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you will be followed up every 3-6 months for one year.

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NCT04169763

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~25 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:CisplatinExternal Beam Radiation TherapyNelfinavir

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recommended phase II dose (RP2D) of nelfinavir
Measured over 1 year
+1 more outcome measured

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

Explore related trials

Vulvar Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

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

Who to contact

Lilie L Lin
[email protected]
713-563-2300
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Recommended phase II dose (RP2D) of nelfinavir1 year

    Defined as the dose for which the isotonic estimate of the dose limiting toxicity (DLT) rate is closest to the target DLT rate of 30%. If there are ties, the higher dose will be chosen as the RP2D when the isotonic estimate is lower than 30%, and the lower dose will be chosen when the isotonic estimate is greater than or equal to 30%.

  • Incidence of adverse events1 year

    Results from the dose escalation phase of study will be summarized by a tabulation of the number of patients treated and the number who experience a DLT at each dose level tested. Comprehensive safety data on all toxicities will be tabulated by type, grade, duration, attribution to treatment, and administered dose level. A patient level summary by worst grade toxicity will be included. Laboratory data and concomitant medications associated with episodes of toxicity will be summarized. Will also report the number of patients who discontinue therapy and the reasons for discontinuation.