Tandutinib in Treating Patients Who Have Undergone Surgery for Metastatic Kidney Cancer

Inclusion Criteria

• Histologically confirmed RCC of clear cell histology; subjects must have a component of conventional clear cell RCC with or without sarcomatoid features
• Patients must have evidence of metastatic disease and must have had a cytoreductive nephrectomy at least 28 days prior to first day of treatment
• Archival tissue from nephrectomy must be available for correlative studies
• Patients must have measurable disease, defined by RECIST criteria
• Patients must have received at least one prior FDA approved therapy for metastatic renal cell carcinoma with either Sutent, or Nexavar, and may have received up to three prior systemic therapies for metastatic disease; prior cytokine therapy is also permitted
• Prior systemic therapy with other antiangiogenic agents such as Thalidomide, Bevacizumab, or AG013736 is permitted
• Patients must have a life expectancy of >= 3 months
• Patients must have an ECOG performance status of 0-1 (Karnofsky >= 70%)
• Patients must be at least 4 weeks from radiation therapy and recovered from all related toxicity
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcL
• Hemoglobin >= 8.5 g/dl
• Total Bilirubin = 500 msec using the Bazett's formula taken from the screening electrocardiogram or history of familial long QT syndrome are ineligible
• Left ventricular ejection fraction (LVEF) = grade 2 (NCI CTCAE v3.0)
• Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow pills or absorb oral medications are excluded
• Known or suspected primary muscular or neuromuscular disease (e.g., muscular dystrophy, myasthenia gravis)
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN518 such as Tarceva™, Iressa® and Cardura® XL
• Patients with any CNS metastases or uncontrolled seizure disorder
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infections or psychiatric illness/social situations that would limit compliance with study requirements
• Any malignancy other than a renal cell carcinoma, with the following exceptions:
• Basal or squamous cell carcinomas of the skin
• Carcinoma in-situ of the uterine cervix
• Any malignancy treated with curative intent and in complete remission for > 3 years
• Patients with organ allografts
• Patients with non-clear cell carcinoma i.e., papillary, collecting duct, or chromophobe
• Pregnant women are excluded from this study because MLN518 is a receptor tyrosine kinase inhibitor with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with MLN518, breastfeeding should be discontinued if the mother is treated with MLN518
• HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with MLN518; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
• Inability to comply with study and/or follow-up procedures