Sunitinib in Treating Patients With Kidney Cancer That Has Spread to the Brain (NCT00814021) | Clinical Trial Compass
CompletedPhase 2
Sunitinib in Treating Patients With Kidney Cancer That Has Spread to the Brain
France21 participantsStarted 2009-04
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 neuropsy…
What they're measuring
1
Objective response rate in the brain after 2 courses
Timeframe: From beginning of treatment until 2 courses of treatment