Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients
This study is using the combination of radiation and antiangiogenic agents (agents that destroy existing blood vessels) seems to be an approach to tumor cure.
Head and Neck Cancer
Nervous System Neoplasms
Radiation: External Beam Radiation Therapy
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase IB, Open-Label, Safety Study of the Combination of Sunitinib and Radiation for the Treatment of Patients With Cancer|
- To evaluate the safety and toxicity profile of sunitinib when used with concurrent radiation therapy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]The purpose of this study is to determine the safety of the combination of the antiangiogenic, sunitinib, when combined with external beam radiotherapy.
- To measure urine VEGF [ Time Frame: 2 years ] [ Designated as safety issue: No ]Urine VEGF may be a biomarker of response. This translational approach may be useful to determine who benefits from treatment.
|Study Start Date:||March 2007|
|Estimated Study Completion Date:||March 2014|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: Sunitinib plus Radiation
Sunitinib plus Radiation
The use of the FDA approved drug sunitinib, used in an "off-label" manner with external beam radiation therapy.
Other Names:Radiation: External Beam Radiation Therapy
Radiotherapy will be administered Monday through Friday for a maximum of 8 weeks. Total dose will depend on the patient's disease site.
The combination of ionizing radiation and antiangiogenic agents seems to be a counterintuitive approach to tumor cure because oxygen is a potent radiosensitizer and a reduction in oxygen concentration would be expected following a reduction in tumor vasculature after antiangiogenic treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437372
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Adam P Dicker, MD, PhD||Thomas Jefferson University|