Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients

NCT00437372 | Completed Phase 1 DMC

• 3 other identifiers: 06C.5492006-30JT 1208
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

solid tumor; central nervous system; head and neck; thorax; pelvic area

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• To measure urine VEGF

  2 years

Study Arms (1)

Sunitinib plus Radiation

EXPERIMENTAL

Sunitinib plus Radiation

Drug: Sunitinib; Radiation: External Beam Radiation Therapy

Interventions

Sunitinib DRUG

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

Also known as: Sutent, SU11248

Sunitinib plus Radiation

External Beam Radiation Therapy RADIATION

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

Also known as: External Beam Radiotherapy, Teletherapy

Sunitinib plus Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimum 2 week course of radiation therapy
• Solid tumors of the central nervous system, head and neck, thorax, and pelvis

You may not qualify if:

• Major surgery or radiation therapy within 4 weeks starting study treatment
• Grade 3 hemorrhage within 4 weeks

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• Pfizer: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

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

MeSH Terms

Conditions

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

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Adam P Dicker, MD, PhD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2007
• First Posted: February 21, 2007
• Study Start: March 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 2, 2025

Record last verified: 2025-05

Locations

US (1)