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Antiviral
ribavirin for Head and Neck Cancers
N/A
Waitlist Available
Led By David Pfisher, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
Study Summary
This trial will enroll patients with HPV-16 positive squamous cell cancer of the tonsil and/or base of tongue who have completed standard therapy or who are not candidates for standard therapy.
Eligible Conditions
- Head and Neck Cancers
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-treatment and post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-treatment and post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To Explore if Ribavirin Therapy for 2 Weeks Decreases Tumor Expression
Secondary outcome measures
To Explore if Ribavirin Reduces the Expression of HPV-16 Oncoproteins E6 and E7
to Explore the Pharmacodynamic Effects of Ribavirin
Side effects data
From 2006 Phase 4 trial • 48 Patients • NCT0008759479%
Fatigue
58%
Nausea
42%
Depression
42%
Insomnia
42%
Decreased appetite
42%
Headache
38%
Irritability
38%
Vomiting
38%
Arthralgia
33%
Neutropenia
33%
Pyrexia
33%
Myalgia
29%
Chills
25%
Alopecia
25%
Rash
21%
Dry mouth
17%
Dry skin
17%
Drug screen positive
17%
Cough
17%
Pharyngolaryngeal pain
13%
Abdominal pain upper
13%
Abdominal pain
13%
Urinary tract infection
13%
Anaemia
13%
Influenza like illness
13%
Hyperhidrosis
13%
Dysgeusia
13%
Dyspnoea
8%
Bronchitis
8%
Constipation
8%
Injection site erythema
8%
Cellulitis
8%
Gastritis
8%
Epistaxis
8%
Tooth extraction
8%
Nasopharyngitis
8%
Rhinorrhoea
8%
Haemoglobin decreased
8%
Hypokalaemia
8%
Asthenia
8%
Rash papular
8%
Lethargy
8%
Paraesthesia
8%
Joint sprain
8%
Vision blurred
4%
Heat stroke
4%
Diarrhoea
4%
Pneumonia aspiration
4%
Bile duct stone
4%
Overdose
4%
Drug withdrawal syndrome
4%
Pain in extremity
4%
Confusional state
4%
Upper respiratory tract infection
4%
Excoriation
4%
Anxiety
4%
Dizziness
4%
Hypoaesthesia
4%
Thrombocytopenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Self-Administration Therapy
Direct Observed Therapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: ribavirinExperimental Treatment1 Intervention
This will be a single institution non-randomized study for patients with tonsil and/or base of tongue squamous cell cancer. This is a pilot study to obtain pharmacodynamic data regarding the effects of ribavirin on tonsil squamous cell cancer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ribavirin
2005
Completed Phase 4
~4610
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,935 Previous Clinical Trials
588,852 Total Patients Enrolled
David Pfisher, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have smoked the equivalent of more than 10 packs of cigarettes per year for many years.You have previously received chemotherapy or radiation treatment for a specific type of throat cancer called tonsillar or base of tongue squamous cell cancer.You have had a previous stroke or mini-stroke (also known as a TIA).You are able to perform daily activities and tasks with little to no difficulty.You have a serious condition that affects the blood vessels in your arms or legs.You have moderate to severe congestive heart failure according to the New York Heart Association (NYHA) grading system.You have had a heart attack or unstable chest pain in the last 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: ribavirin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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