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Phase 2 N=8 Treatment

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

Kidney Cancer · Melanoma (Skin) · Metastatic Cancer

Enrolled (actual)
8
Serious AEs
50.0%
Results posted
Dec 2015
Primary outcome: Primary: Central Nervous System (CNS) Response Rate by RECIST Criteria — 3; 2 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
sunitinib malate (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Memorial Sloan Kettering Cancer Center
Primary completion
Aug 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Central Nervous System (CNS) Response Rate by RECIST Criteria
3; 2

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00462982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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