Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients

NCT ID: NCT00437372

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Cancer Head and Neck Cancer Pelvic Cancer Nervous System Neoplasms Thoracic Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sunitinib plus Radiation

Sunitinib plus Radiation

Group Type EXPERIMENTAL

Sunitinib

Intervention Type DRUG

The use of the FDA approved drug sunitinib, used in an "off-label" manner with external beam radiation therapy.

External Beam Radiation Therapy

Intervention Type RADIATION

Radiotherapy will be administered Monday through Friday for a maximum of 8 weeks. Total dose will depend on the patient's disease site.

Interventions

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Sunitinib

The use of the FDA approved drug sunitinib, used in an "off-label" manner with external beam radiation therapy.

Intervention Type DRUG

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.

Intervention Type RADIATION

Other Intervention Names

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Sutent SU11248 External Beam Radiotherapy Teletherapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adam P Dicker, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

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Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Related Links

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http://www.KimmelCancerCenter.org

Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center

http://www.JeffersonHospital.org

Thomas Jefferson University Hospitals

Other Identifiers

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2006-30

Identifier Type: OTHER

Identifier Source: secondary_id

JT 1208

Identifier Type: OTHER

Identifier Source: secondary_id

06C.549

Identifier Type: -

Identifier Source: org_study_id

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