Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00437372
• Other study ID #: 06C.549
• Secondary ID: 2006-30
• Status: Completed
• Phase: Phase 1
• First received: February 20, 2007
• Last updated: October 19, 2016
• Start date: March 2007
• Est. completion date: December 2010

Study information

• Verified date: October 2016
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

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.

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years	Yes
Secondary	To measure urine VEGF	Urine VEGF may be a biomarker of response. This translational approach may be useful to determine who benefits from treatment.	2 years	No

External Links

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