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Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients

Primary Purpose

Cancer, Head and Neck Cancer, Pelvic Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sunitinib
External Beam Radiation Therapy
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring solid tumor, central nervous system, head and neck, thorax, pelvic area

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas Jefferson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sunitinib plus Radiation

Arm Description

Sunitinib plus Radiation

Outcomes

Primary Outcome Measures

To evaluate the safety and toxicity profile of sunitinib when used with concurrent radiation therapy
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
Urine VEGF may be a biomarker of response. This translational approach may be useful to determine who benefits from treatment.

Full Information

First Posted
February 20, 2007
Last Updated
October 19, 2016
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00437372
Brief Title
Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients
Official Title
A Phase IB, Open-Label, Safety Study of the Combination of Sunitinib and Radiation for the Treatment of Patients With Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Head and Neck Cancer, Pelvic Cancer, Nervous System Neoplasms, Thoracic Neoplasms
Keywords
solid tumor, central nervous system, head and neck, thorax, pelvic area

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sunitinib plus Radiation
Arm Type
Experimental
Arm Description
Sunitinib plus Radiation
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Other Intervention Name(s)
Sutent, SU11248
Intervention Description
The use of the FDA approved drug sunitinib, used in an "off-label" manner with external beam radiation therapy.
Intervention Type
Radiation
Intervention Name(s)
External Beam Radiation Therapy
Other Intervention Name(s)
External Beam Radiotherapy, Teletherapy
Intervention Description
Radiotherapy will be administered Monday through Friday for a maximum of 8 weeks. Total dose will depend on the patient's disease site.
Primary Outcome Measure Information:
Title
To evaluate the safety and toxicity profile of sunitinib when used with concurrent radiation therapy
Description
The purpose of this study is to determine the safety of the combination of the antiangiogenic, sunitinib, when combined with external beam radiotherapy.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To measure urine VEGF
Description
Urine VEGF may be a biomarker of response. This translational approach may be useful to determine who benefits from treatment.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam P Dicker, MD, PhD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.JeffersonHospital.org
Description
Thomas Jefferson University Hospitals

Learn more about this trial

Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients

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