Sunitinib in Treating Patients With Kidney Cancer That Has Spread to the Brain

April 10, 2026 updated by: Institut Claudius Regaud

Phase II Study, Multicenter, Open-label, Evaluating Efficacy of Treatment With Sutent® (Sunitinib) in Patients With Previously Untreated or Recurrent Brain Metastases Originating From Renal Cancer

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with kidney cancer that has spread to the brain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the objective response rate in the brain after 2 courses of sunitnib malate in patients with previously untreated or recurrent brain metastases secondary to renal cancer following radiotherapy or surgery.

Secondary

  • Evaluate duration of response.
  • Evaluate objective response of non-CNS targets.
  • Evaluate time to disease progression.
  • Evaluate overall and progression-free survival.
  • Evaluate neurological symptoms associated with the tumor.
  • Evaluate feasibility and overall tolerance of this drug.

OUTLINE: This is a multicenter study.

Patients receive oral sunitinib malate once daily for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

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

  • France
      • Toulouse, France, 31052
        • Institut Claudius Regaud

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the kidney

    • Metastatic disease
  • Measurable disease by RECIST criteria

  • Presence of previously untreated or recurrent brain metastases following radiotherapy or surgery

    • No brain metastasis revealed by hemorrhage
    • No single brain metastasis < 2 cm that is accessible by surgery or radiosurgery

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2 (unless paresis due to brain metastases)
  • ANC > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Hemoglobin > 8 g/dL
  • PT or INR < 1.5 times upper limit of normal (ULN)
  • AST/ALT < 2.5 times ULN (< 5 times ULN in the case of liver metastases)
  • Total bilirubin < 1.5 times ULN
  • Serum creatinine < 200 μmol/L
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for up to 30 days following completion of study treatment
  • No other cancer except for in situ cervical cancer, curatively treated basal cell carcinoma of the skin, or other curatively treated cancer without evidence of recurrence within the past 5 years
  • No uncontrolled hypertension (systolic BP ≥ 160 mm Hg and/or diastolic BP ≥ 90 mm Hg)

  • None of the following cardiac conditions within the past 6 months:

    • Significant cardiovascular disease
    • NYHA class III-IV congestive heart failure
    • Myocardial infarction
    • Unstable angina
    • Severe arrhythmia
    • Cerebrovascular accident
    • Severe thromboembolism
  • No serious neuropsychiatric disease
  • No psychological, familial, social, or geographic situations that preclude clinical follow-up
  • No patient deprived of liberty by a court or administrative order
  • Able to understand French

PRIOR CONCURRENT THERAPY:

  • At least 6 months since prior antineoplastic treatment with sunitinib malate
  • At least 4 weeks since other prior treatment
  • At least 3 weeks since prior hematopoietic growth factors (i.e., filgrastim [G-CSF] or sargramostim [GM-CSF])
  • No concurrent antivitamin K at curative or anticoagulation doses

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sunitinib,
Drug: sunitinib malate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate in the brain after 2 courses
Time Frame: From beginning of treatment until 2 courses of treatment
From beginning of treatment until 2 courses of treatment

Collaborators and Investigators

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

Sponsor

Institut Claudius Regaud

Investigators

  • Study Chair: Christine Chevreau-Dalbianco, MD, Institut Claudius Regaud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

December 20, 2008

First Submitted That Met QC Criteria

December 20, 2008

First Posted (Estimated)

December 23, 2008

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07URO02
  • ICREGAUD-07URO02
  • ICREGAUD-Metastases Cerebrales
  • INCA-RECF0821
  • PFIZER-ICREGAUD-07URO02
  • EUDRACT-2008-000948-13

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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