Clinical Trial: Study of Sunitinib in Patients With Von Hippel-Lindau (VHL) Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Single-arm, Phase II Study of Sunitinib in Patients With Von Hippel-Lindau (VHL) Disease

Brief Summary:

VHL patients may benefit from sunitinib. This study will investigate the following objectives :

PRIMARY OBJECTIVE

  • 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.

SECONDARY OBJECTIVES

  • 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.

Detailed Summary:

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.


Sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

Dates:
Date Received: March 18, 2010
Date Started: March 2010
Date Completion:
Last Updated: September 12, 2012
Last Verified: September 2012