Stereotactic Body Radiotherapy (SBRT) and Sorafenib in Patients With Metastatic, Recurrent, or Unresectable Renal Cell Cancer (RCC)

November 23, 2016 updated by: Duke University

Phase I/II Trial Evaluating Toxicity and Efficacy of Adding Stereotactic Body Radiotherapy to Sorafenib in Patients With Metastatic, Recurrent, or Unresectable Renal Cell Cancer

The purpose of this study is to determine the safety and efficacy of combined stereotactic body radiotherapy (SBRT) + sorafenib in the treatment of patients with Stage IV renal cell carcinoma (RCC) who have recurred locally, developed progression of an unresectable primary or progression of extra-cranial and/or extra-pulmonary metastases while on sorafenib. All subjects will remain on sorafenib during SBRT.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

In the phase I portion of this investigation, subjects will be enrolled in cohorts of three to the SBRT dose groups. Subjects will remain on sorafenib therapy during SBRT. Any change in sorafenib dosage before, during or after SBRT will be at the discretion of the subject's medical oncologist. Subjects will be assessed during, immediately after and at 4 and 8 weeks post-therapy for toxicity.

Stereotactic body radiotherapy will be given in increasingly higher dose levels each cohort until the maximum tolerated dose of radiation is determined.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 years old
  • Zubrod Performance Status 0 or 1

  • Adequate bone marrow, liver and renal function as assessed by the following:

    • Hemoglobin > 9.0 g/dl
    • Absolute neutrophil count (ANC) > 1,500/mm3
    • Platelet count > 100,000/mm3
    • Total bilirubin < 1.5 times institutional upper limit of normal (ULN)
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 times the institutional ULN
    • Creatinine < 1.5 times institutional ULN
  • Histologically or cytologically confirmed renal cell carcinoma, which is metastatic, unresectable or recurrent.
  • Life expectancy > 6 months
  • Local recurrence or progression of primary lesion or progression, or symptomatic progression in extra-cranial, extra-pulmonary metastases while on sorafenib
  • Measurable disease
  • Bone metastases must have a tissue component measurable by imaging.
  • No untreated brain metastases
  • Resolution of pre-existing toxicity from prior therapy excluding alopecia and taste alteration.
  • Willingness and ability to comply with continuing sorafenib, visits, treatment plans, laboratory tests and study procedures.
  • All treated lesions must comply with SBRT dose constraints
  • More than 28 days since any prior systemic or local therapy for this cancer, including investigational agents and surgical procedures exclusive of sorafenib
  • Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control)
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.
  • Ability to understand and the willingness to sign a written informed consent.
  • Prothrombin time(PT) and partial thromboplastin time (PTT) within normal limits.

Exclusion Criteria:

  • Lesion in remaining (solo) kidney
  • Contraindications to radiotherapy or prior radiotherapy overlapping current site(s) of disease.
  • Cardiac disease: Congestive heart failure. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
  • Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
  • Active clinically serious infection
  • Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
  • Pulmonary hemorrhage/bleeding event within 4 weeks of first dose of study drug.
  • Any other hemorrhage/bleeding event within 4 weeks of first dose of study drug.
  • Serious non-healing wound, ulcer, or bone fracture.
  • Evidence or history of bleeding problems
  • Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
  • Use of St. John's Wort or rifampin (rifampicin).
  • Known or suspected allergy to sorafenib or any agent given in the course of this trial.
  • Any condition that impairs patient's ability to swallow whole pills.
  • Any malabsorption problem.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Overall Complete and Partial Response (CR+PR)
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Bayer

Investigators

  • Principal Investigator: John Kirkpatrick, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

May 4, 2008

First Submitted That Met QC Criteria

May 4, 2008

First Posted (Estimate)

May 6, 2008

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

November 23, 2016

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00001398

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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