Sunitinib in Treating Patients With Brain Metastases Caused by Kidney Cancer or Melanoma
Condition: Kidney Cancer; Melanoma (Skin); Metastatic Cancer
MeSH terms: Melanoma; Kidney Neoplasms; Carcinoma, Renal Cell
Intervention: sunitinib malate
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IV melanoma; tumors metastatic to brain; stage IV renal cell cancer; recurrent melanoma; recurrent renal cell 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.
    

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)