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

Primary Purpose

Kidney Cancer, Metastatic Cancer

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

sunitinib malate

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage IV renal cell cancer, tumors metastatic to brain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Institut Claudius Regaud

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sunitinib,

Arm Description

Outcomes

Primary Outcome Measures

Objective response rate in the brain after 2 courses

Secondary Outcome Measures

Full Information

NCT ID

NCT00814021

First Posted

December 20, 2008

Last Updated

November 4, 2014

Sponsor

Institut Claudius Regaud

1. Study Identification

Unique Protocol Identification Number

NCT00814021

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Claudius Regaud

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Cancer, Metastatic Cancer

Keywords

recurrent renal cell cancer, stage IV renal cell cancer, tumors metastatic to brain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

sunitinib,

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

sunitinib malate

Primary Outcome Measure Information:

Title

Objective response rate in the brain after 2 courses

Time Frame

From beginning of treatment until 2 courses of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christine Chevreau-Dalbianco, MD

Organizational Affiliation

Institut Claudius Regaud

Official's Role

Study Chair

Facility Information:

Facility Name

Institut Claudius Regaud

City

Toulouse

ZIP/Postal Code

31052

Country

France

12. IPD Sharing Statement

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

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