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

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Claudius Regaud
• Treatments: Sunitinib

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