Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients

October 19, 2016 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

39

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators

Pfizer

Investigators

  • Principal Investigator: Adam P Dicker, MD, PhD, Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

February 20, 2007

First Submitted That Met QC Criteria

February 20, 2007

First Posted (Estimate)

February 21, 2007

Study Record Updates

Last Update Posted (Estimate)

October 21, 2016

Last Update Submitted That Met QC Criteria

October 19, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06C.549
  • 2006-30 (Other Identifier: CCRRC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Clinical Trials on Sunitinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe