Nervous System Disorders

Category: Cancer (Oncology), HIC#13605
Title:
Phase II Trial of Sunitinib (SU011248) in Patients with Recurrent or Inoperable Meningioma
Contact:Sandra Oliphant
Phone:(434)982-0871
E-mail:slo2n@virginia.edu

Meningiomas are a type of brain tumor. The usual treatments include surgery, radiation therapy/radiosurgery, and chemotherapy. Surgery is the treatment of choice for symptomatic patients, but significant percentage of patients may not be candidates for surgical resection. Radiation therapy is the primary treatment for inoperable meningiomas. Radiation therapy is also used as secondary treatment after surgery in some patients. Unfortunately, tumors may recur following surgery or radiation therapy. In those cases treatment options are limited. There is no known cure for recurrent meningioma. The use of chemotherapy in the treatment of meningioma is limited.

The purpose of this study is to look at survival rate of those treated with an investigational medicine called Sunitinib. Participants will have a routine history and physical exam performed, tumor evaluations by magnetic resonance imaging (MRI), and routine blood tests.

You may qualify for the study if you:
" Are a male or non-pregnant female age 18 or older
" Have histologically proven recurrent meningioma or intracranial hemangiopericytoma or hemangioblastoma
" Have evidence of tumor progression by MRI or CT scan within 14 days of entering study
" Have recovered from recent surgery for your tumor
" Had prior chemotherapy, radiation therapy, interstitial brachytherapy, or radiosurgery more than 4 weeks (28 days) prior to study entry

You may not qualify for this study if you have/had/are:
" History of any other cancer (patients with non-melanoma skin cancer or carcinoma in-situ of the cervix may be eligible if in complete remission and off all therapy for the disease for a minimum of 3 years)
" Receiving any other investigational agents
" Are using certain antiepileptic medications or St John's Wort
" Heart attack, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, stroke, or pulmonary embolism, uncontrolled hypertension, thyroid abnormality, history of bleeding in your brain
" On treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg daily for prevention of blood clothing is allowed)
" Pregnant women or nursing women

You will not receive payment for participating in this study

For more information or to see if you qualify, please contact:
Contact: Goga Radakovic
Phone: (434) 243-5750
Email: gr2p@virginia.edu

Primary Investigator: David Schiff, MD
Accepts adult enrollment: YES
IRB-HSR# 13605

Primary Investigator: Schiff David,
Department: Neurology
Accepts adult enrollment :YES
Accepts minor enrollment :NO