Sunitinib in Treating Patients With Brain Metastases Caused by Kidney Cancer or Melanoma

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

DISEASE CHARACTERISTICS:

• Histologically confirmed melanoma or renal cell carcinoma

  • Metastatic brain disease

• Must have assessable target intracranial lesion(s), defined as measurable disease ≥ 10 mm in longest diameter that is not appropriate for stereotactic radiosurgery or surgical resection

  • Lesions previously treated with radiosurgery AND not eligible for resection can only be used as target lesions if there has been true tumor progression on baseline scan (i.e., ≥ 20% increase in longest diameter of lesion) rather than radionecrosis

    • True progression must be confirmed by PET scan or other corroborating imaging used to distinguish radionecrosis
• No leptomeningeal metastases or primary dural metastases

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-1 OR Karnofsky PS 60-100%
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Total leukocyte count ≥ 3,000/mm³
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Creatinine ≤ 2.0 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• Hemoglobin ≥ 9.0 g/dL
• Calcium ≤ 12.0 mg/dL
• AST and ALT ≤ 1.5 times ULN
• PT ≤ 1.5 times ULN
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• No uncontrolled medical illness including, but not limited to, any of the following:

  • Hypertension (i.e., blood pressure > 150/100 mm Hg)
  • Thyroid disease
  • Severe valvular disease
  • Severe pulmonary disease
  • HIV/AIDS
  • Severe psychiatric illness
• No cardiac dysrhythmia ≥ grade 2
• No prolonged QTc interval on baseline EKG

• No systemic hemorrhage ≥ grade 2 within the past 4 weeks

  • No CNS hemorrhage ≥ grade 2

    • Grade 1 (asymptomatic) CNS hemorrhage allowed at investigator's discretion

• None of the following within the past 6 months:

  • Myocardial infarction
  • Unstable angina
  • Symptomatic congestive heart failure
  • Stroke/transient ischemic attack
  • Pulmonary embolism
• Ejection fraction ≥ 50% by baseline echocardiogram OR < 20% decrease in ejection fraction from a prior study

PRIOR CONCURRENT THERAPY:

• No prior multi-targeted tyrosine kinase inhibitor therapy (e.g., sunitinib malate or sorafenib)
• No coronary/peripheral arterial bypass surgery within the past 6 months
• More than 4 weeks since prior surgery and recovered
• More than 4 weeks since prior and no other concurrent experimental therapy or cytotoxic chemotherapy
• More than 4 weeks since prior immunotherapy
• More than 2 weeks since prior stereotactic radiosurgery and recovered
• More than 7 days since prior and no concurrent drugs that interact with CYP3A4 family, including enzyme-inducing antiepileptic drugs, warfarin, or Hypericum perforatum extract (St. John's wort)