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Squamous Cell Carcinoma of Head and Neck

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Neoplasms, Squamous Cell

Head and Neck Neoplasms

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Nelfinavir

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Single Arm, Phase II study of Nelfinavir Lead-In (Period 1) Followed by Concurrent Chemoradiation with Nelfinavir (Period 2)

Period 1: Nelfinavir Lead-In (1250 mg bid, 7-14 days).

Nelfinavir (Viracept®) 1250 mg

Period 2: Concurrent Chemoradiation (70 Gy over 7 weeks) with Nelfinavir (1250 mg bid)

Chemoradiation

Alexander Lin, MD

This is a Phase II trial of definitive chemoradiotherapy (CTRT) given with the protease inhibitor,Nelfinavir (NFV), in patients with locally advanced head and neck. Eligible patients will receive a "lead-in" period of Nelfinavir (1250 mg po bid) for 7-14 days prior to initiation of CTRT. Nelfinavir will then be given concurrently with platinum-based chemotherapy and radiation therapy (planned total dose of 70 Gy over 7 weeks).

This is a single-arm Phase II study of organ-preservation chemoradiotherapy given in combination with the protease inhibitor, Nelfinavir, in patients with stage II, IVa, or IVb (per AJCC version 7) squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx. Patients start treatment with Nelfinvir at a dose of 1250 mg twice daily for 7-14 days, before continuing Nelfinvir at this dose concurrent with chemotherapy and radiation therapy (for a total dose of 70 Gy over a period of 7 weeks).

Phase II Trial of Nelfinavir With Concurrent Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck

A Phase II Trial of a Protease Inhibitor, Nelfinavir (NFV), Given With Definitive, Concurrent Chemoradiotherapy (CTRT) in Patients With Locally-Advanced, Human Papilloma Virus (HPV) Negative, Squamous Cell Carcinoma of the Head and Neck

locoregional control determined via diagnostic imaging and clinical examination.

Decrease in Hypoxia from Nelfinavir was determined by change in uptake and volume as assessed via 18f-FMISO or 18f-EF5 PET/CT pre-Nelfinavir versus post Nelfnavir lead-in

Change in Glucose Metabolism from Nelfinavir was determined by change in glucose uptake as assessed via FDG-PET/CT pre-Nelfinavir versus post Nelfnavir lead-in

Abramson Cancer Center at Penn Medicine

Single Arm Phase 2

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Locoregional head and neck cancer

Locoregional Control

Period 1: Nelfinavir Lead-In (1250 mg bid, 7-14 days)

Period 2: Definitive Chemoradiotherapy with Nelfinavir (70 Gy radiotherapy over 7 weeks)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase II Trial of Nelfinavir With Concurrent Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck	NCT02207439	Head and Neck S...	Nelfinavir (Vir... Chemoradiation	18 Years -	Abramson Cancer Center at Penn Medicine
Phase II Trial of Nelfinavir With Concurrent Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck	NCT02207439	Head and Neck S...	Nelfinavir (Vir... Chemoradiation	18 Years -	Abramson Cancer Center at Penn Medicine

Spots Global Cancer Trial Database for nelfinavir (viracept®) 1250 mg