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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

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ClinicalTrials.gov Identifier: NCT02207439
Recruitment Status : Active, not recruiting
First Posted : August 4, 2014
Last Update Posted : July 2, 2021
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Stage III, IVa, or IVb Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Larynx, or Hypopharynx Drug: Nelfinavir (Viracept®) 1250 mg Drug: FMISO Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : July 2014
Actual Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022


Arm Intervention/treatment
Experimental: Single Arm Phase 2 Drug: Nelfinavir (Viracept®) 1250 mg
Drug: FMISO



Primary Outcome Measures :
  1. Determine locoregional control [ Time Frame: 5 years ]
    To determine locoregional control for patients with locally advanced, HPV-negative head and neck cancer, treated with definitive NFV + CTRT and compare it to published historical results.


Secondary Outcome Measures :
  1. Assessment of Nelfinavir on hypoxia [ Time Frame: 5 years ]
    To determine the effect of NFV on hypoxia as assessed by F-MISO PET/CT scanning.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ≥ 18 years old.
  • Histologically confirmed diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx stages III, IVa, or IVb, p16-negative on immunohistochemistry
  • Determined by the treating physician to be a candidate for organ preserving, concurrent standard chemotherapy and radiation therapy to the head and neck with definitive intent.
  • ECOG Performance Status 0-2
  • Patients must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits.
  • The effects of EF5 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, during study, until 1 month after completion of the final FMISO PET/CT scan. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Serum pregnancy testing will be required for women of childbearing potential.
  • Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria

  • Prior radiation therapy to the head and neck
  • Prior chemotherapy within the past 5 years
  • Previous therapy with a human immunodeficiency virus (HIV) protease inhibitor
  • Pregnant or lactating patients.
  • Patients with known HIV disease. These patients have a high probability of treatment with anti-retroviral therapy which may interact with the nelfinavir.
  • Absolute Neutrophil Count ≤ 1500 per mm3
  • Platelet count ≤ 100,000 per mm3
  • Serum creatinine > 1.5 times the upper limit of normal
  • Serum AST or ALT > 2 times the upper limit of normal
  • Serum bilirubin > 1.2 mg/dl
  • Weight loss of > 10% over the past 6 months which is due to tumor wasting syndrome
  • Distant metastases
  • Patients receiving the following drugs that are contraindicated with NFV will be excluded: Antiarrhythmics:amiodarone, quinidine, Antimycobacterial: rifampin, Ergot Derivatives:dihydroergotamine, ergonovine, ergotamine, methylergonovine, Herbal Products: St.John's wort (hypericum perforatum), HMG-CoA Reductase Inhibitors: lovastatin,simvastatin, Neuroleptic:pimozide, Proton Pump Inhibitors, Sedative/Hypnotics: midazolam, triazolam,
  • Patients receiving the following drugs will be clinically evaluated as to whether dosage/medication can be changed to permit patient on study: Anti-Convulsants: carbamazepine, Phenobarbital, Anti-Convulsant:phenytoin, Anti-Mycobacterial:rifabutin, PDE5 Inhibitors: sildenafil, vardenafil, tadalafil, HMG-CoA: Reductase Inhibitors: atorvastatin, rosuvastatin, Immuno-suppressants: cyclosporine,tacrolimus, sirolimus, Narcotic Analgesic: methadone, Oral Contraceptive:ethinyl estradiol, Macrolide Antibiotic:azithromycin, Inhaled/nasal steroid fluticasone, Antidepressant: trazodone.
  • Women of childbearing potential who have a positive result on screening urine pregnancy test.
  • Subjects with moderate-severe renal disease.
  • History of allergic reactionsattributed to Flagyl (metronidazole), which has a chemical structure similar to FMISO.
  • Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02207439


Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Alexander Lin, MD Abramson Cancer Center of the University of Pennsylvania
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02207439    
Other Study ID Numbers: UPCC 15313
First Posted: August 4, 2014    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: June 2021
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Papilloma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Nelfinavir
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents