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A Phase II Study of SU11248 (Sunitinib) in Patients With Renal Cell Carcinoma and Melanoma Metastatic to the Brain

Phase 2
18 Years
Not Enrolling
Kidney Cancer, Melanoma (Skin), Metastatic Cancer

Thank you

Trial Information

A Phase II Study of SU11248 (Sunitinib) in Patients With Renal Cell Carcinoma and Melanoma Metastatic to the Brain



- 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.


- 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

After completion of study therapy, patients are followed periodically.

Inclusion Criteria


- 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

- True progression must be confirmed by PET scan or other corroborating
imaging used to distinguish radionecrosis

- No leptomeningeal metastases or primary dural metastases


- 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


- 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


- No prior multi-targeted tyrosine kinase inhibitor therapy (e.g., sunitinib malate or

- 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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

CNS response (complete and partial response) rate by RECIST criteria

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Lauren E. Abrey, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

March 2007

Completion Date:

August 2008

Related Keywords:

  • Kidney Cancer
  • Melanoma (Skin)
  • Metastatic Cancer
  • stage IV melanoma
  • tumors metastatic to brain
  • stage IV renal cell cancer
  • recurrent melanoma
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Melanoma
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Memorial Sloan-Kettering Cancer Center New York, New York  10021