Skip to main content
OpenTrials
Completed

NCT Number: NCT00437372

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pelvic Cancer Pelvic Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sunitinib

Drug

The use of the FDA approved drug sunitinib, used in an "off-label" manner with external beam radiation therapy.

Other names: Sutent, SU11248

external beam radiation therapy

Radiation

Radiotherapy will be administered Monday through Friday for a maximum of 8 weeks. Total dose will depend on the patient's disease site.

Other names: External Beam Radiotherapy, Teletherapy

Primary outcomes

  1. 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

  1. To measure urine VEGF

    Time frame: 2 years

    Urine VEGF may be a biomarker of response. This translational approach may be useful to determine who benefits from treatment.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Collaborators

  • Pfizer

Registry information

Official study title

A Phase IB, Open-Label, Safety Study of the Combination of Sunitinib and Radiation for the Treatment of Patients With Cancer

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 21, 2007
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.