Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma|
- To evaluate the activity of sunitinib in patients with recurrent meningiomas as measured by 6-month progression-free survival. [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- To evaluate the safety of sunitinib in patients with recurrent meningiomas. [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
- To develop exploratory data correlating response to the molecular phenotype of the tumor. [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
- To develop exploratory data correlating serum angiogenic peptides and Dynamic Contrast Enhanced (DCE)-MRI with outcomes. [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Sunitinib will be administered at a dose of 50 mg orally once daily for four consecutive weeks, followed by a two-week rest period. Intra-patient dose reduction may be required depending on the type and severity of individual toxicity encountered. Imaging studies will be performed after every other cycle. Patients may continue on study as long as they are tolerating treatment and in the absence of disease progression.
The study drug will be administered on an outpatient basis. The starting dose will be 50 mg daily for 28 days (4 consecutive weeks) followed by 14 days off for patients not on CYP3A4 inducers or inhibitors. A cycle equals 42 days.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00589784
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, New Jersey|
|Memoral Sloan Kettering Cancer Center|
|Basking Ridge, New Jersey, United States|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center at Commack|
|Commack, New York, United States, 11725|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburg, Pennsylvania, United States|
|United States, Virginia|
|University of Virginia Health Science Center|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Thomas Kaley, MD||Memorial Sloan-Kettering Cancer Center|