Conditions: Kidney Cancer
Keywords: stage I renal cell cancer stage II renal cell cancer stage III renal cell cancer stage IV renal cell cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: no

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. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This clinical trial is studying the side effects of giving sunitinib before surgery and to see how well it works in treating patients with localized or metastatic kidney cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the safety of sunitinib malate in patients with localized or metastatic renal cell carcinoma.
* Determine the safety of surgery after 90 days of treatment with sunitinib malate in these patients.

Secondary

* Determine response of these patients after 90 days of treatment with sunitinib malate.

OUTLINE: Patients receive oral sunitinib malate once daily on days 1-90 in the absence of disease progression or unacceptable toxicity. Patients then undergo radical nephrectomy.

After completion of study treatment, patients are followed for 3 months.

Arms:
arm 1: None

Interventions: intervention 1: sunitinib malate intervention 2: neoadjuvant therapy intervention 3: therapeutic conventional surgery
Intervention descriptions: intervention 1: oral intervention 2: IV intervention 3: Surgery

Protocol document: