Actively Recruiting
Nelfinavir, Cisplatin, and External Beam Radiation Therapy for the Treatment of Locally Advanced Vulvar Cancer That Cannot Be Removed by Surgery
Led by M.D. Anderson Cancer Center · Updated on 2025-10-22
25
Participants Needed
1
Research Sites
333 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Nelfinavir, Cisplatin, and External Beam Radiation Therapy for the Treatment of Locally Advanced Vulvar Cancer That Cannot Be Removed by Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with primary, untreated invasive vulvar carcinoma not suitable for surgery, stages T2-T4, N0-3, M0
- Histological confirmation of primary invasive vulvar cancer
- Absolute neutrophil count (ANC) of at least 1,500/microliter within 28 days before consent
- Platelet count of at least 100,000/microliter within 28 days before consent
- Creatinine level less than 2.0 mg/dL within 28 days before consent
- Total bilirubin no more than 1.5 times the normal limit within 28 days before consent
- SGOT (glutamic-oxaloacetic transaminase) no more than 3 times normal within 28 days before consent
- ECOG/GOG performance status of 0, 1, or 2
- Patients with ureteral obstruction must have treatment such as stent or nephrostomy tube
- Consent given within 12 weeks of diagnosis or patient must be restaged
- Patients of childbearing potential must use effective birth control
- Confirmed HIV negative status within 3 months before consent
- Signed informed consent and authorization for release of personal health information
You will not qualify if you...
- Patients with stage T1N0 vulvar cancer
- Evidence of metastases outside the radiation field at staging
- Prior pelvic or abdominal radiation, chemotherapy, or any treatment for vulvar cancer
- Presence of severe infection or septicemia
- Conditions preventing completion of the study or required follow-up
- Pregnant patients not willing to terminate pregnancy before treatment
- Renal abnormalities requiring radiation field modification
- Other cancers within last 5 years except non-melanoma skin cancer
- Gastrointestinal conditions preventing oral medication absorption
- Poorly controlled diabetes despite treatment
- Current use of specific anti-arrhythmic, sedative, or other listed interacting medications
- Patients with phenylketonuria
- Estimated glomerular filtration rate (eGFR) less than 30
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
L
Lilie L Lin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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