Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

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

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.

Detailed description: 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: 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)

Relevance to patient case: not relevant