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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sunitinib Malate 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.

Participant Flow:   Overall Study
    Sunitinib Malate
STARTED   2 
COMPLETED   0 
NOT COMPLETED   2 
Adverse Event                1 
Withdrawal by Subject                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sunitinib Malate 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).

Baseline Measures
   Sunitinib Malate 
Overall Participants Analyzed 
[Units: Participants]
 2 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   2 
>=65 years   0 
Age 
[Units: Years]
Mean (Full Range)
 48.5 
 (45 to 52) 
Gender 
[Units: Participants]
 
Female   2 
Male   0 
Region of Enrollment 
[Units: Participants]
 
United States   2 


  Outcome Measures

1.  Primary:   Change in Best Corrected Visual Acuity (BCVA) From Baseline to Week 36   [ Time Frame: Baseline and 36 Weeks ]

2.  Secondary:   Change in Retinal Thickness From Baseline to Week 36   [ Time Frame: Baseline and 36 Weeks ]

3.  Secondary:   Change in Retinal Angioma Leakage From Baseline to Week 36   [ Time Frame: Baseline and 36 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: meyerlec@nei.nih.gov


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