Nelfinavir, Cisplatin, and External Beam Radiation Therapy for the Treatment of Locally Advanced Vulvar Cancer That Cannot Be Removed by Surgery
Recruiting
Phase 1
Interventional Study
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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 25 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Other
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About This Trial
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 chemotherap…
Trial Locations
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Eligibility Criteria
Inclusion 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 invasi…
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