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

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Sunitinib

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)