Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients

Phase 1

Completed

• Conditions: Cancer; Head and Neck Cancer; Pelvic Cancer; Nervous System Neoplasms; Thoracic Neoplasms
• Interventions: Drug: Sunitinib; Radiation: External Beam Radiation Therapy

• Registration Number: NCT00437372
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

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.

Study Timeline

• Study First Submitted: 2007-02-20
• Study First Submitted QC: 2007-02-20
• Study First Posted: 2007-02-21
• Study Start: 2007-03
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sunitinib plus Radiation	Sunitinib	Sunitinib plus Radiation
Sunitinib plus Radiation	External Beam Radiation Therapy	Sunitinib plus Radiation

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and toxicity profile of sunitinib when used with concurrent radiation therapy	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 Outcome Measures

Name	Time	Method
To measure urine VEGF	2 years	Urine VEGF may be a biomarker of response. This translational approach may be useful to determine who benefits from treatment.

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States