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

NCT04169763 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 2019-0629NCI-2019-07570
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Recommended phase II dose (RP2D) of nelfinavir

  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%.

  1 year

• Incidence of adverse events

  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.

  1 year

Secondary Outcomes (2)

• Progression-free survival

  1 year

• Overall survival

  1 year

Study Arms (1)

Treatment (nelfinavir, cisplatin, EBRT)

EXPERIMENTAL

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.

Drug: Cisplatin; Radiation: External Beam Radiation Therapy; Drug: Nelfinavir

Interventions

Cisplatin DRUG

Given IV

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone''s Chloride, Peyrone''s Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

Treatment (nelfinavir, cisplatin, EBRT)

External Beam Radiation Therapy RADIATION

Undergo EBRT

Also known as: Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy, External Beam RT, external radiation, External Radiation Therapy, external-beam radiation, Radiation, External Beam

Treatment (nelfinavir, cisplatin, EBRT)

Nelfinavir DRUG

Given PO

Treatment (nelfinavir, cisplatin, EBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Vulvar Neoplasms

Interventions

Cisplatin; 1,2-diaminocyclohexaneplatinum II citrate; Platinum; Radiation; Nelfinavir

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Physical Phenomena; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lilie L Lin

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lilie L Lin

CONTACT

713-563-2300; lllin@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: August 7, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 22, 2025

Record last verified: 2025-10

Locations

US (1)