Study of Sunitinib in Patients With Von Hippel-Lindau (VHL) Disease (VHLSUT)
|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: NCT01168440|
Recruitment Status : Completed
First Posted : July 23, 2010
Last Update Posted : September 13, 2012
VHL patients may benefit from sunitinib. This study will investigate the following objectives :
- To determine the objective response rate according to RECIST criteria, in VHL patients with advanced tumors or tumors untreatable by other means, and treated with sunitinib.
- To evaluate the safety and tolerability of sunitinib in VHL patients according to the NCI-CTC criteria Version 3.0.
- To determine the following time-to-event endpoints: overall survival, time to disease progression, progression free survival, time to response and duration of response.
- To evaluate quality of life in VHL patients receiving sunitinib.
|Condition or disease||Intervention/treatment||Phase|
|Von Hippel-Lindau Disease||Drug: Sunitinib||Phase 2|
Treatment with sunitinib, 50 mg PO daily, 6 weeks courses with schedule 4/2 (4 weeks of treatment followed by 2 weeks of rest).
Treatment until disease progression or unacceptable toxicity.
Dose reduction depending on type and severity of toxicity. At the end of treatment period (after 8 courses), responding and well tolerating patients will be allowed to receive sunitinib upon investigator's opinion.
Follow-up for up to 24 months from inclusion.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-arm, Phase II Study of Sunitinib in Patients With Von Hippel-Lindau (VHL) Disease|
|Study Start Date :||March 2010|
|Primary Completion Date :||February 2011|
|Study Completion Date :||February 2011|
U.S. FDA Resources
- Objective response rate (RECIST criteria) [ Time Frame: Every 6 weeks ]Course: 4 weeks sunitinib / 2weeks rest. Response assessment: after 4 weeks and 8 weeks of sunitinib (1 extra assessment by contrast-enhanced US after 2 weeks for kidney tumors). Then every 6 weeks for eye and every 12 weeks for all other tumors.
- Safety and tolerability (NCI-CTC criteria Version 3.0). [ Time Frame: Every 6 weeks ]
- Time-to-event endpoints: overall survival, time to disease progression, progression free survival, time to response and duration of response. [ Time Frame: Every 6 weeks ]
- Quality of life in VHL patients receiving sunitinib. [ Time Frame: Every 6 weeks ]
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): NCT01168440
|Hospital Saint André - Service de cancérologie|
|Bordeaux, France, 33075|
|Kremlin-Bicêtre, France, 94275|
|Hôpital Européen Georges Pompidou - Service d'Oncologie Médicale|
|Paris, France, 75015|
|Principal Investigator:||Stephane RICHARD, MD, PhD||Hôpital Kremlin-Bicêtre (France)|
|Study Director:||Reza T ELAIDI, PhD||ARTIC (Hopital Européen Georges Pompidou, FRANCE)|