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

NCT01896271 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-08-23

Study results available
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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

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

Sponsors & Collaborators

  • Prometheus Laboratories

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Raquibul Hannan, MD, PhD · University of Texas Southwestern Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-02
Primary Completion
2020-08-25
Completion
2021-04-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01896271 on ClinicalTrials.gov