Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status and phase: Completed; Phase 1

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

Treatments: Drug: Sunitinib; Radiation: External Beam Radiation Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00437372

JT 1208 (Other Identifier)

06C.549

2006-30 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Sunitinib plus Radiation

Experimental group

Description:

Sunitinib plus Radiation

Treatment:

Radiation: External Beam Radiation Therapy

Drug: Sunitinib