Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00437372
First received: February 20, 2007
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Cancer
Head and Neck Cancer
Pelvic Cancer
Nervous System Neoplasms
Thoracic Neoplasms
Drug: Sunitinib
Radiation: External Beam Radiation Therapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • To evaluate the safety and toxicity profile of sunitinib when used with concurrent radiation therapy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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:
  • To measure urine VEGF [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Urine VEGF may be a biomarker of response. This translational approach may be useful to determine who benefits from treatment.


Enrollment: 39
Study Start Date: March 2007
Estimated Study Completion Date: March 2014
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437372

Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Pfizer
Investigators
Principal Investigator: Adam P Dicker, MD, PhD Thomas Jefferson University
  More Information

Additional Information:
No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00437372     History of Changes
Other Study ID Numbers: 06C.549, 2006-30
Study First Received: February 20, 2007
Last Updated: November 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
solid tumor
central nervous system
head and neck
thorax
pelvic area

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Nervous System Neoplasms
Thoracic Neoplasms
Pelvic Neoplasms
Neoplasms by Site
Nervous System Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014