NCT01896271

High Dose IL-2 and Stereotactic Ablative Body Radiation Therapy for Metastatic Renal Cancer

A Phase II Trial of High Dose IL-2 and Stereotactic Ablative Body Radiation Therapy (SABR) for Patients With Metastatic Clear Cell Renal Cell Cancer (mRCC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the stereotactic radiation to multiple metastatic sites is delivered not only to eradicate sites of bulky progressive disease, but also to provide antigen presentation and immune stimulation which is expected to act synergistically when immediately followed by the non-specific immune stimulation provided by treatment with HD IL-2 and thereby increase the response rate and complete response for metastatic clear cell renal cell cancer patients. Both HD IL-2 and SABR are FDA approved therapeutic cancer treatment

Conditions

• Metastatic Clear Cell Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	IL-2	HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion
RADIATION	Stereotactic Ablative Body Radiation Therapy	SABR dose varying from 8Gy-20Gy in 1-3 fractions

Timeline

• Start date: 2013-10-02
• Primary completion: 2020-08-25
• Completion: 2021-04-20
• First posted: 2013-07-11
• Last updated: 2021-08-23
• Results posted: 2021-08-23

Locations

1 site across 1 country: United States