Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Vulvar Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Vulvar Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Vulvar Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Cisplatin

Nelfinavir

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

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.

External Beam Radiation Therapy

Lilie L Lin

Lilie L. Lin

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.

PRIMARY OBJECTIVES:

I. To determine the safety and dose limiting toxicities of nelfinavir in combination with cisplatin plus inguinal +/-pelvic radiation therapy for treatment of patients with unresectable T2-4, N0-3 vulvar carcinoma.

II. To determine the recommended phase II dose of nelfinavir combined with chemoradiotherapy.

SECONDARY OBJECTIVES:

I. To determine recurrence site (local/distant), progression-free survival and overall survival.

II. To determine the levels of Akt activity (and downstream effectors such as pGSK3, pEBP1) and p16INK4A in addition to the presence of human papilloma virus (HPV) 16 and 18, and E6/E7 ribonucleic acid (RNA) in vulvar biopsy specimens of patients at up to two(2) different time points (1. pre nelfinavir, pre-radiation, 2. while on nelfinavir, pre-radiation).

OUTLINE:

Patients receive nelfinavir orally (PO) twice daily (BID) for up to 8 weeks. Starting week 2, patients also receive cisplatin intravenously (IV) over 60-90 minutes once weekly during weeks 2-8. Patients undergo external beam radiation therapy (EBRT) for 5 consecutive days between weeks 2-8. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3-6 months for 1 year.

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

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

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%.

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.

Will be estimated using the product-limit method developed by Kaplan and Meier. Will report rates at specific times (e.g., at 6 and 12 months) and medians, if attained, with corresponding 95% confidence interval.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Behaviors and Mental Disorders

Uterine Cervical Neoplasms

Vaginal Neoplasms

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Vaginal Diseases

Quality of Life

Vaginal Cancer

Patients receive sexual health counseling prior to starting and at the completion of radiation.

Counseling

Quality-of-Life Assessment

Questionnaire Administration

Allison M Quick, MD

This phase I trial studies a sexual health counseling intervention during radiation therapy in improving quality of life for women with gynecologic cancer. Women with gynecologic cancer often suffer long-term complications from treatment that can affect their physical and psychological well-being. An early sexual health counseling intervention prior to and after radiation may improve symptoms management and reduce the physical and psychological effects of treatment.

PRIMARY OBJECTIVE:

I. To determine the feasibility of a sexual health counseling intervention before and after pelvic radiation for women with gynecologic cancers.

SECONDARY OBJECTIVE:

I. To preliminarily evaluate the efficacy of a sexual health counseling intervention on patient reported outcomes in quality of life, sexual function, and genitourinary symptoms.

OUTLINE:

Patients receive sexual health counseling prior to starting and at the completion of radiation.

After completion of study, patients are followed up at 1 and 6 months after radiation.

Sexual Health Counseling Intervention During Radiation Therapy in Improving Quality of Life for Women With Gynecologic Cancer

Counseling Intervention During Radiation Therapy for Women With Gynecologic Cancer

Patients' characteristics and responses to the questionnaires will be summarized using appropriate summary statistics based on their distributions. Parametric tests such as the student's t test and Chi-square test or nonparametric tests such as Mann-Whitney U test and Fisher's exact test will be used to compare patients' characteristics between patients who completed the program and those who did not.

Will be assesses using the European Organization for Research and Treatment of Cancer (EORTC) Core QoL Questionnaire (EORTC QLQ-C30). Data will be displayed graphically using boxplots, histograms and scatterplots to identify interesting features and potential outliers.

Will be assessed using the EORTC QLQ-CX24. Data will be displayed graphically using boxplots, histograms and scatterplots to identify interesting features and potential outliers.

Will be assessed using the VHA. Data will be displayed graphically using boxplots, histograms and scatterplots to identify interesting features and potential outliers.The Vaginal Health Assessment, the examination tool used in the clinical validation of the VAS, will be utilized to for the gynecologic physical examination for all patients. 15 The assessment evaluates the physical aspect of the vagina including agglutination, adhesions, pH, dryness, rugosity, elasticity, length, thickness, epithelial integrity, vascularity, and irritation. Vaginal diameter will also be assessed during the manual portion of the exam.

Estimates will be \<2.5, 2.5, 3.0, 3.5, 4.0 or \>4 cm. 16

Will be assessed using the VAS. Data will be displayed graphically using boxplots, histograms and scatterplots to identify interesting features and potential outliers. Each item is scored from 0 (none) to 3 (severe) and a composite score is calculated by taking the mean of the items.

A lower score indicates better function. In cancer patients and survivors, the scale were found to have high internal consistency.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nelfinavir, Cisplatin, and External Beam Radiation Therapy for the Treatment of Locally Advanced Vulvar Cancer That Cannot Be Removed by Surgery	NCT04169763	Stage II Vulvar... Stage III Vulva... Stage IIIA Vulv... Stage IIIB Vulv... Stage IIIC Vulv... Stage IVA Vulva...	Cisplatin External Beam R... Nelfinavir	18 Years -	M.D. Anderson Cancer Center
Sexual Health Counseling Intervention During Radiation Therapy in Improving Quality of Life for Women With Gynecologic Cancer	NCT04269837	Malignant Femal... Stage I Cervica... Stage I Uterine... Stage I Vaginal... Stage I Vulvar ... Stage IA Cervic... Stage IA Uterin... Stage IA Vagina... Stage IA Vulvar... Stage IA1 Cervi... Stage IA2 Cervi... Stage IB Cervic... Stage IB Uterin... Stage IB Vagina... Stage IB Vulvar... Stage IB1 Cervi... Stage IB2 Cervi... Stage II Cervic... Stage II Uterin... Stage II Vagina... Stage II Vulvar... Stage IIA Cervi... Stage IIA Vagin... Stage IIA1 Cerv... Stage IIA2 Cerv... Stage IIB Cervi... Stage IIB Vagin... Stage III Cervi... Stage III Uteri... Stage III Vagin... Stage III Vulva... Stage IIIA Cerv... Stage IIIA Uter... Stage IIIA Vulv... Stage IIIB Cerv... Stage IIIB Uter... Stage IIIB Vulv... Stage IIIC Uter... Stage IIIC Vulv... Stage IIIC1 Ute... Stage IIIC2 Ute... Stage IVA Cervi... Stage IVA Uteri... Stage IVA Vagin... Stage IVA Vulva...	Counseling Quality-of-Life... Questionnaire A...	18 Years -	Ohio State University Comprehensive Cancer Center
Nelfinavir, Cisplatin, and External Beam Radiation Therapy for the Treatment of Locally Advanced Vulvar Cancer That Cannot Be Removed by Surgery	NCT04169763	Stage II Vulvar... Stage III Vulva... Stage IIIA Vulv... Stage IIIB Vulv... Stage IIIC Vulv... Stage IVA Vulva...	Cisplatin External Beam R... Nelfinavir	18 Years -	M.D. Anderson Cancer Center
Nelfinavir, Cisplatin, and External Beam Radiation Therapy for the Treatment of Locally Advanced Vulvar Cancer That Cannot Be Removed by Surgery	NCT04169763	Stage II Vulvar... Stage III Vulva... Stage IIIA Vulv... Stage IIIB Vulv... Stage IIIC Vulv... Stage IVA Vulva...	Cisplatin External Beam R... Nelfinavir	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for stage iiic vulvar cancer ajcc v8