A Phase IB, Open-Label, Safety Study of the Combination of Sunitinib and Radiation for the Treatment of Patients With Cancer
Overview
- Phase
- Phase 1
- Intervention
- Sunitinib
- Conditions
- Cancer
- Sponsor
- Sidney Kimmel Cancer Center at Thomas Jefferson University
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- To evaluate the safety and toxicity profile of sunitinib when used with concurrent radiation therapy
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Minimum 2 week course of radiation therapy
- •Solid tumors of the central nervous system, head and neck, thorax, and pelvis
Exclusion Criteria
- •Major surgery or radiation therapy within 4 weeks starting study treatment
- •Grade 3 hemorrhage within 4 weeks
Arms & Interventions
Sunitinib plus Radiation
Sunitinib plus Radiation
Intervention: Sunitinib
Sunitinib plus Radiation
Sunitinib plus Radiation
Intervention: External Beam Radiation Therapy
Outcomes
Primary Outcomes
To evaluate the safety and toxicity profile of sunitinib when used with concurrent radiation therapy
Time Frame: 2 years
The purpose of this study is to determine the safety of the combination of the antiangiogenic, sunitinib, when combined with external beam radiotherapy.
Secondary Outcomes
- To measure urine VEGF(2 years)