RECRUITING

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

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase I Study of Nelfinavir and Cisplatin Chemotherapy Concurrent With Pelvic Radiation for Locally Advanced Vulvar Cancer Not Amenable to Surgical Resection

Quick Facts

Study Start:2020-08-07

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04169763

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Lilie L Lin

CONTACT

713-563-2300

lllin@mdanderson.org

Principal Investigator

Lilie L Lin

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Lilie L Lin, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-07

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2020-08-07

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

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