Sunitinib to Treat Recurrent Brain Cancer

Summary

Background: One way tumors are able to grow is by forming new blood vessels that supply them with nutrients and oxygen. Sunitinib blocks certain proteins on the surface of tumor and blood vessel cells that are involved with the formation of new blood vessels. Blocking these proteins may prevent the tumor cells or blood vessels from continuing to grow. Objectives: To determine whether sunitinib can cause tumors to shrink or stabilize in patients with recurrent brain cancer. Eligibility: Patients 18 years of age or older with brain cancer whose disease has worsened after standard treatment with surgery, radiation. Design: Patients take a sunitinib pill once a day in 4-week treatment cycles. Treatment may continue as long as the tumor remains stable or decreases in size and the side effects of treatment are tolerated. Routine blood tests are done every 2 weeks during the first 8 weeks of treatment and then every 4 weeks after that. Magnetic resonance imaging (MRI) scans are done before starting treatment (at baseline) and at the end of every 4-week cycle to monitor tumor growth. Positron emission tomography (PET) scans are done at baseline and at the end of the first cycle. Neurological and physical examinations are done at baseline, at week 2 of treatment and at the end of every treatment cycle. Health-related quality of life is assessed every 4 weeks. Pregnancy tests, electrocardiograms and echocardiograms are repeated as needed.

Timeline

Start

2008-06

Primary completion

2012-06

Completion

2012-06

Outcome

Outcome not reported

Stopped: “The study was terminated based on results of an interim analysis for futility.”

Publications

• Background Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin. 2007 Jan-Feb;57(1):43-66. doi: 10.3322/canjclin.57.1.43.
• Background Prados MD, Schold SC Jr, Fine HA, Jaeckle K, Hochberg F, Mechtler L, Fetell MR, Phuphanich S, Feun L, Janus TJ, Ford K, Graney W. A randomized, double-blind, placebo-controlled, phase 2 study of RMP-7 in combination with carboplatin administered intravenously for the treatment of recurrent malignant glioma. Neuro Oncol. 2003 Apr;5(2):96-103. doi: 10.1093/neuonc/5.2.96.
• Background Prados MD, Warnick RE, Mack EE, Chandler KL, Rabbitt J, Page M, Malec M. Intravenous carboplatin for recurrent gliomas. A dose-escalating phase II trial. Am J Clin Oncol. 1996 Dec;19(6):609-12. doi: 10.1097/00000421-199612000-00016.

Drugs

Indications