CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
IL-2 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01896271
NCT01896271Phase 2Completed

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)

University of Texas Southwestern Medical Center·interventional·Posted Jul 11, 2013·Updated Aug 23, 2021

In Brief

A Phase 2 clinical trial evaluating IL-2 and Stereotactic Ablative Body Radiation Therapy for Metastatic Clear Cell Renal Cell Carcinoma. Completed, enrolled 30 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 11, 2013
Enrollment StartOct 2, 2013
Primary CompletionAug 25, 2020
Study CompletionApr 20, 2021
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 13.0 years ago

Interventions

IL-2drug

HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion

Stereotactic Ablative Body Radiation Therapyradiation

SABR dose varying from 8Gy-20Gy in 1-3 fractions