Status:
COMPLETED
Sunitinib in Treating Patients With Brain Metastases Caused by Kidney Cancer or Melanoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Melanoma (Skin)
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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 we...
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00462982
Start Date
March 1 2007
End Date
August 1 2008
Last Update
December 30 2015
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021