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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Cancer, Head and Neck Cancer, Pelvic Cancer, Nervous System Neoplasms, Thoracic Neoplasms

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety and toxicity profile of sunitinib when used with concurrent radiation therapy

Outcome Description:

The purpose of this study is to determine the safety of the combination of the antiangiogenic, sunitinib, when combined with external beam radiotherapy.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Adam P Dicker, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University

Authority:

United States: Institutional Review Board

Study ID:

06C.549

NCT ID:

NCT00437372

Start Date:

March 2007

Completion Date:

March 2013

Related Keywords:

  • Cancer
  • Head and Neck Cancer
  • Pelvic Cancer
  • Nervous System Neoplasms
  • Thoracic Neoplasms
  • solid tumor
  • central nervous system
  • head and neck
  • thorax
  • pelvic area
  • Neoplasms
  • Head and Neck Neoplasms
  • Nervous System Neoplasms
  • Thoracic Neoplasms
  • Pelvic Neoplasms

Name

Location
Thomas Jefferson University Philadelphia, Pennsylvania  19107-6541