Conditions: Brain and Central Nervous System Tumors Sarcoma
Keywords: adult grade I meningioma adult grade II meningioma adult grade III meningioma adult malignant hemangiopericytoma adult anaplastic meningioma adult papillary meningioma adult melanocytic lesion recurrent adult brain tumor
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.

Patients who are responding may remain on study treatment for 12 months.

Interventions: intervention 1: vatalanib
Intervention descriptions: intervention 1: None

Protocol document: