Trial Outcomes & Findings for Pharmacodynamic Effects of Ribavirin in Patients With Tonsil and/or Base of Tongue Squamous Cell Carcinoma (NCT NCT01268579)
NCT ID: NCT01268579
Last Updated: 2023-10-02
Results Overview
of phosphorylated eIF4E among patients with tonsillar squamous cell carcinoma.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
2 weeks
Results posted on
2023-10-02
Participant Flow
Participant milestones
| Measure |
Ribavirin
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.
ribavirin: The clinical intervention in this study is ribavirin therapy for approximately 14 days. Ribavirin 800 mg/day is administered in divided doses, 400 mg PO qAM and 400 mg PO qPM.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Ribavirin
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.
ribavirin: The clinical intervention in this study is ribavirin therapy for approximately 14 days. Ribavirin 800 mg/day is administered in divided doses, 400 mg PO qAM and 400 mg PO qPM.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Pharmacodynamic Effects of Ribavirin in Patients With Tonsil and/or Base of Tongue Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Ribavirin
n=9 Participants
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.
ribavirin: The clinical intervention in this study is ribavirin therapy for approximately 14 days. Ribavirin 800 mg/day is administered in divided doses, 400 mg PO qAM and 400 mg PO qPM.
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksof phosphorylated eIF4E among patients with tonsillar squamous cell carcinoma.
Outcome measures
| Measure |
Ribavirin
n=9 Participants
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.
ribavirin: The clinical intervention in this study is ribavirin therapy for approximately 14 days. Ribavirin 800 mg/day is administered in divided doses, 400 mg PO qAM and 400 mg PO qPM.
|
|---|---|
|
To Explore if Ribavirin Therapy for 2 Weeks Decreases Tumor Expression
Decreased p-eIF4E after 14 days of ribavirin
|
4 Participants
|
|
To Explore if Ribavirin Therapy for 2 Weeks Decreases Tumor Expression
No decreased p-eIF4E after 14 days of ribavirin
|
2 Participants
|
|
To Explore if Ribavirin Therapy for 2 Weeks Decreases Tumor Expression
Not evaluable
|
3 Participants
|
SECONDARY outcome
Timeframe: pre-treatment and post treatmentPopulation: N/A - data were not collected
on molecules that may be regulated directly or indirectly by eIF4E (eg, p16, p21, EGFR, p53).). Immunohistochemistry will be performed on Pathology samples (e.g. diagnostic biopsy), as well as on the post-treatment surgical pathology samples (e.g. definitive surgery),to describe the effects of ribavirin treatment on the expression of phosphorylated eIF4E.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: In pre- and post-treatment tumor samplesPopulation: N/A - data were not collected
Pathology samples (e.g. diagnostic biopsy), as well as on the post-treatment surgical pathology samples (e.g. definitive surgery)
Outcome measures
Outcome data not reported
Adverse Events
Ribavirin
Serious events: 0 serious events
Other events: 9 other events
Deaths: 8 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ribavirin
n=9 participants at risk
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.
ribavirin: The clinical intervention in this study is ribavirin therapy for approximately 14 days. Ribavirin 800 mg/day is administered in divided doses, 400 mg PO qAM and 400 mg PO qPM.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
6/9 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
55.6%
5/9 • Up to 1 year
|
|
Investigations
Blood bilirubin increase
|
33.3%
3/9 • Up to 1 year
|
|
General disorders
Fatigue
|
33.3%
3/9 • Up to 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
22.2%
2/9 • Up to 1 year
|
|
Investigations
Aspartate aminotransferase increase
|
22.2%
2/9 • Up to 1 year
|
|
General disorders
Fever
|
22.2%
2/9 • Up to 1 year
|
|
Gastrointestinal disorders
Gastroesophageal Reflux
|
22.2%
2/9 • Up to 1 year
|
|
Investigations
Weight loss
|
22.2%
2/9 • Up to 1 year
|
|
Investigations
Alanine aminotransferase increase
|
11.1%
1/9 • Up to 1 year
|
|
Investigations
Alkaline phosphatase increase
|
11.1%
1/9 • Up to 1 year
|
Additional Information
Dr. David Pfister MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4237
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place