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Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00437372
Recruitment Status : Completed
First Posted : February 21, 2007
Last Update Posted : October 21, 2016
Information provided by (Responsible Party):
Thomas Jefferson University ( 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.

Condition or disease Intervention/treatment Phase
Cancer Head and Neck Cancer Pelvic Cancer Nervous System Neoplasms Thoracic Neoplasms Drug: Sunitinib Radiation: External Beam Radiation Therapy Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sunitinib plus Radiation
Sunitinib plus Radiation
Drug: Sunitinib
The use of the FDA approved drug sunitinib, used in an "off-label" manner with external beam radiation therapy.
Other Names:
  • Sutent
  • SU11248

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.
Other Names:
  • External Beam Radiotherapy
  • Teletherapy

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00437372

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United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
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Principal Investigator: Adam P Dicker, MD, PhD Thomas Jefferson University

Additional Information:
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University Identifier: NCT00437372     History of Changes
Other Study ID Numbers: 06C.549
2006-30 ( Other Identifier: CCRRC )
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016

Keywords provided by Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University ):
solid tumor
central nervous system
head and neck
pelvic area

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Nervous System Neoplasms
Nervous System Diseases
Thoracic Neoplasms
Pelvic Neoplasms
Neoplasms by Site
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action