NCT00348790

Vatalanib in Treating Patients With Recurrent or Progressive Meningioma

A Phase II Trial of PTK-787 in Recurrent or Progressive Meningiomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Vatalanib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well vatalanib works in treating patients with recurrent or progressive meningioma.

Detailed description

OBJECTIVES: Primary * Determine the efficacy of vatalanib, in terms of radiographic improvement and clinical improvement, in patients with recurrent or progressive meningioma. Secondary * Determine the 6-month progression-free survival of these patients. * Describe the response rate and overall survival of these patients. * Determine the safety of vatalanib in these patients. * Correlate the response rates with expression of vascular endothelial growth factor, epidermal growth factor receptor, platelet-derived growth factor, and HER2. * Develop exploratory data concerning surrogate markers of angiogenic activity in vivo using magnetic resonance perfusion. OUTLINE: Patients receive oral vatalanib twice daily on days 1-28. Courses repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 1 year. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Conditions

• Brain and Central Nervous System Tumors
• Sarcoma

Interventions

Type	Name	Description
DRUG	vatalanib

Timeline

• Start date: 2006-05-01
• Primary completion: 2010-11-01
• Completion: 2013-07-01
• First posted: 2006-07-06
• Last updated: 2018-10-26
• Results posted: 2014-10-27

Locations

3 sites across 1 country: United States