Clinical Trial: Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma
Brief Summary:
The purpose of this study is to find out what effects, good and/or bad, sunitinib has on patients and their tumors. At this time, no drugs are routinely used to treat meningioma, hemangioblastoma or hemangiopericytoma. Only surgery and radiation therapy are known to be useful.
Sunitinib is a drug approved for advanced kidney cancer. Sunitinib is also being studied for other tumors. It may be useful in the treatment of brain tumors because it can prevent formation of new blood vessels that allow tumor cells to survive and grow.
Detailed Summary: This is a phase II study of Sunitinib in patients with recurrent or inoperable meningiomas. An exploratory study will be performed for patients with recurrent hemangiopericytoma or hemangioblastoma. There will be approximately 50 patients enrolled on this study (40 meningiomas and 10 hemangiopericytomas/hemangioblastomas). The treatment plan is to use daily SU11248 at a dose of 50 mg, using the established schedule of 4 weeks of treatment followed by two weeks of rest period, forming a six-week treatment cycle. A medical professional will see each patient at least every six weeks while on the medication for toxicity assessment and physical examination. Extent of disease evaluations will occur at baseline, two weeks, twelve weeks, 24 weeks, and every twelve weeks thereafter. These evaluations will include MRI of the brain (or CT head if a patient cannot undergo MRI) and MR perfusion.
Sponsor: Memorial Sloan Kettering Cancer Center
Current Primary Outcome: Overall Objective Response [ Time Frame: 1.5 years ]
Original Primary Outcome: To evaluate the activity of sunitinib in patients with recurrent meningiomas as measured by 6-month progression-free survival. [ Time Frame: 1.5 years ]
Current Secondary Outcome:
Original Secondary Outcome: To describe the response rate, median-time-to-progression and overall survival in this patient population; To evaluate the safety of sunitinib in patients with recurrent meningiomas. [ Time Frame: 1.5 years ]
Information By: Memorial Sloan Kettering Cancer Center
Dates:
Date Received: December 26, 2007
Date Started: October 2007
Date Completion:
Last Updated: December 21, 2015
Last Verified: December 2015
