NCT02307474

A Pilot Study of SBRT With Adjuvant Pazopanib for Renal Cell Cancer

CASE 10813: A Pilot Study of SBRT With Adjuvant Pazopanib for Renal Cell Carcinoma

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies the side effects of stereotactic body radiation therapy and pazopanib hydrochloride in treating patients with kidney cancer who are not able to undergo surgery. Stereotactic body radiation therapy is a specialized radiation therapy that delivers high doses of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Pazopanib hydrochloride may stop the growth of tumor cells by blocking an enzyme needed for cell growth. Giving pazopanib hydrochloride before stereotactic body radiation therapy may help make the tumor smaller and be an alternative treatment for patients who cannot undergo surgery.

Detailed description

PRIMARY OBJECTIVES: I. To determine the rate of treatment related toxicity reports following stereotactic body radiation therapy (SBRT) and pazopanib (pazopanib hydrochloride) as a determination of the tolerability of combined therapy in patients with clear cell renal cell carcinoma (RCC). SECONDARY OBJECTIVES: I. To determine the tumor diameter/volume change prior to and following pazopanib treatment prior to SBRT. II. To determine the impact of pre SBRT pazopanib therapy on radiation therapy target volumes for evidence of tumor shrinkage. III. To evaluate tumor change in radiation therapy target volumes and the incidence of treatment related toxicity reports and sparing of non-involved nephron. IV. Report change in tumor control following pazopanib and SBRT as evaluated by post treatment repeat biopsy and/or Response Evaluation Criteria in Solid Tumors (RECIST) criteria. OUTLINE: Patients receive pazopanib hydrochloride orally (PO) daily for up to 60 days. Patients then continue to receive pazopanib hydrochloride PO daily and undergo SBRT every other day over days 60-65. After completion of study treatment, patients are followed up at 1, 3, 6, 12, 18, and 24 months.

Conditions

• Clear Cell Renal Cell Carcinoma
• Renal Cell Carcinoma

Interventions

Type	Name	Description
RADIATION	Stereotactic Radiosurgery	3 fractions of 16 Gy per fraction to a total dose of 48 Gy on non-consecutive day within a 10 day time span
DRUG	Pazopanib Hydrochloride	Given PO starting at 800mg to be systematically altered following drug related toxicities.

Timeline

• Start date: 2015-09-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2014-12-04
• Last updated: 2016-03-03

Locations

2 sites across 1 country: United States