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Sunitinib Malate to Treat Advanced Eye Disease in Patients With Von Hippel-Lindau Syndrome (VHL3)

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ClinicalTrials.gov Identifier: NCT00673816
Recruitment Status : Terminated (Inability to recruit and adequate number of participants)
First Posted : May 7, 2008
Results First Posted : December 19, 2011
Last Update Posted : December 19, 2011
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Von Hippel-Lindau Syndrome
Intervention Drug: Sunitinib Malate
Enrollment 2
Recruitment Details The recruitment goal was to enroll five participants; however, the study was terminated after only two participants had been enrolled as a result of slow recruitment and adverse events. Date of enrollment of the first participant was December 10, 2008, and the study was terminated on December 1, 2010.
Pre-assignment Details  
Arm/Group Title Sunitinib Malate
Hide Arm/Group Description Participants were expected to receive 9 months of sunitinib malate therapy administered in 6 cycles. Each cycle consisted of a daily oral dose of 50 mg sunitinib malate for 4 weeks followed by a 2-week rest period). Only one participant remained in the study for the Week 36 measures.
Period Title: Overall Study
Started 2
Completed 0
Not Completed 2
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             1
Arm/Group Title Sunitinib Malate
Hide Arm/Group Description Participants were expected to receive 9 months of sunitinib malate therapy administered in 6 cycles. Each cycle consisted of a daily oral dose of 50 mg sunitinib malate for 4 weeks followed by a 2-week rest period).
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants
48.5
(45 to 52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
2
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Change in Best Corrected Visual Acuity (BCVA) From Baseline to Week 36
Hide Description Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Time Frame Baseline and 36 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Left Eye Right Eye
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: ETDRS Letters
1 -5
2.Secondary Outcome
Title Change in Retinal Thickness From Baseline to Week 36
Hide Description Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.
Time Frame Baseline and 36 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Left Eye Right Eye
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: µm
116 1
3.Secondary Outcome
Title Change in Retinal Angioma Leakage From Baseline to Week 36
Hide Description Leakage of the retinal angioma was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the "Edit Segmentation" function of the Cirrus HD-OCT software. In cases where a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of leakage volume.
Time Frame Baseline and 36 Weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sunitinib Malate
Hide Arm/Group Description Participants were expected to receive 9 months of sunitinib malate therapy administered in 6 cycles. Each cycle consisted of a daily oral dose of 50 mg sunitinib malate for 4 weeks followed by a 2-week rest period). Only one participant remained in the study for the Week 36 measures.
All-Cause Mortality
Sunitinib Malate
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sunitinib Malate
Affected / at Risk (%) # Events
Total   0/2 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sunitinib Malate
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Blood and lymphatic system disorders   
Thrombocytopenia  1  1/2 (50.00%)  1
Ear and labyrinth disorders   
Vertigo  1  1/2 (50.00%)  1
Endocrine disorders   
Hypothyroidism  1  1/2 (50.00%)  1
Eye disorders   
Cataract  1  1/2 (50.00%)  1
Gastrointestinal disorders   
Diarrhoea  1  1/2 (50.00%)  3
Sensitivity of teeth  1  1/2 (50.00%)  2
Stomatitis   1/2 (50.00%)  2
Gastrooesophageal reflux disease  1  2/2 (100.00%)  4
Constipation  1  1/2 (50.00%)  1
Paraesthesia oral   1/2 (50.00%)  1
Dyspepsia  1  1/2 (50.00%)  1
Glossodynia  1  1/2 (50.00%)  2
Lip pain  1  1/2 (50.00%)  1
Oral discomfort  1  1/2 (50.00%)  1
Glossitis  1  1/2 (50.00%)  1
General disorders   
Fatigue  1  2/2 (100.00%)  3
Chills  1  2/2 (100.00%)  5
Temperature intolerance  1  1/2 (50.00%)  1
Asthenia  1  1/2 (50.00%)  1
Infections and infestations   
Urinary tract infection  1  1/2 (50.00%)  1
Investigations   
Urine analysis abnormal  1  1/2 (50.00%)  1
Alanine aminotransferase increased   1/2 (50.00%)  1
Blood creatine phosphokinase decreased  1  1/2 (50.00%)  1
Blood bilirubin increased  1  1/2 (50.00%)  1
Platelet count decreased  1  2/2 (100.00%)  3
Blood creatine decreased  1  1/2 (50.00%)  1
Blood pressure increased  1  1/2 (50.00%)  1
Blood alkaline phosphatase increased  1  1/2 (50.00%)  1
Blood lactate dehydrogenase increased  1  1/2 (50.00%)  1
Weight decreased   1/2 (50.00%)  1
Blood thyroid stimulating hormone increased  1  1/2 (50.00%)  1
Red blood cell count decreased  1  1/2 (50.00%)  1
White blood cell count decreased  1  1/2 (50.00%)  1
Metabolism and nutrition disorders   
Hypoalbuminaemia  1  1/2 (50.00%)  1
Decreased appetite  1  1/2 (50.00%)  1
Musculoskeletal and connective tissue disorders   
Neck pain  1  1/2 (50.00%)  1
Musculoskeletal chest pain  1  1/2 (50.00%)  1
Pain in extremity  1  1/2 (50.00%)  1
Nervous system disorders   
Dizziness  1  1/2 (50.00%)  1
Hyperaesthesia  1  1/2 (50.00%)  1
Dysgeusia  1  1/2 (50.00%)  3
Headache  1  2/2 (100.00%)  5
Psychiatric disorders   
Sleep disorder  1  1/2 (50.00%)  1
Reproductive system and breast disorders   
Vaginal haemorrhage  1  1/2 (50.00%)  2
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  1/2 (50.00%)  2
Sinus congestion  1  1/2 (50.00%)  1
Skin and subcutaneous tissue disorders   
Nail disclouration   1/2 (50.00%)  1
Rash  1  2/2 (100.00%)  2
Onychoclasis  1  1/2 (50.00%)  1
Hair disorder  1  1/2 (50.00%)  1
Skin discomfort  1  1/2 (50.00%)  2
Surgical and medical procedures   
Tooth extraction  1  1/2 (50.00%)  1
Vascular disorders   
Hypertension  1  1/2 (50.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Early termination of the trial resulted in a small number of participants being analyzed, and Microperimetry (MP-1) results were not accurate for either participant due to fixation issues.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Catherine Meyerle, MD
Organization: National Eye Institute
Phone: 301-435-7821
Publications:
Patyna S, Peng G. Distribution of sunitinib and its active metabolite in brain and spinal cord tissue following oral or intravenous administration in rodents and monkeys. European Journal of Cancer Suppl 4(12):21(Abstract 56), 2006.
http://www.rxlist.com/cgi/generic/sutent
http://www.pfizer/download/uspi_sutent.pdf
http://ctep.cancer.gov/forms/CTCAEv3.pdf
http://ctep.cancer.gov/guidelines/recist.html
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )
ClinicalTrials.gov Identifier: NCT00673816     History of Changes
Other Study ID Numbers: 080129
08-EI-0129 ( Other Identifier: National Eye Institute )
First Submitted: May 6, 2008
First Posted: May 7, 2008
Results First Submitted: September 27, 2011
Results First Posted: December 19, 2011
Last Update Posted: December 19, 2011