sunitinib in treating patients with brain metastases caused by kidney cancer or melanoma

Conditions: Kidney Cancer; Melanoma (Skin); Metastatic Cancer

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 brain metastases caused by kidney cancer or melanoma.

objectives: primary * determine the efficacy of sunitinib malate, in terms of objective radiographic response of brain lesions, in patients with brain metastases secondary to renal cell carcinoma or melanoma. secondary * determine overall and progression-free survival. outline: patients receive oral sunitinib malate once daily on days 1-28. courses repeat every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. after completion of study therapy, patients are followed periodically.

Eligibility criteria:
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)

Keywords: stage iv melanoma tumors metastatic to brain stage iv renal cell cancer recurrent melanoma recurrent renal cell cancer