Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients

NCT00437372

Last updated date
Study Location
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cancer, Head and Neck Cancer, Pelvic Cancer, Nervous System Neoplasms, Thoracic Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Minimum 2 week course of radiation therapy

- Solid tumors of the central nervous system, head and neck, thorax, and pelvis

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Major surgery or radiation therapy within 4 weeks starting study treatment


- Grade 3 hemorrhage within 4 weeks

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Cancer, Head and Neck Cancer, Pelvic Cancer, Nervous System Neoplasms, Thoracic NeoplasmsPhase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients
NCT00437372
  1. Philadelphia, Pennsylvania
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients
Official Title  ICMJE A Phase IB, Open-Label, Safety Study of the Combination of Sunitinib and Radiation for the Treatment of Patients With Cancer
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Head and Neck Cancer
  • Pelvic Cancer
  • Nervous System Neoplasms
  • Thoracic Neoplasms
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Sunitinib plus Radiation
Sunitinib plus Radiation
Interventions:
  • Drug: Sunitinib
  • Radiation: External Beam Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2012)
39
Original Enrollment  ICMJE
 (submitted: February 20, 2007)
27
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00437372
Other Study ID Numbers  ICMJE 06C.549
2006-30 ( Other Identifier: CCRRC )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
Study Sponsor  ICMJE Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Adam P Dicker, MD, PhDThomas Jefferson University
PRS Account Thomas Jefferson University
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP