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Sunitinib in Treating Patients With Brain Metastases Caused by Kidney Cancer or Melanoma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00462982
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Kidney Cancer
Melanoma (Skin)
Drug: sunitinib malate
Phase II

MedlinePlus related topics: Cancer Kidney Cancer Melanoma
Drug Information available for: Sunitinib Sunitinib malate Malic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of SU11248 (Sunitinib) in Patients With Renal Cell Carcinoma and Melanoma Metastatic to the Brain

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • CNS response (complete and partial response) rate by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: March 2007
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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.

PROJECTED ACCRUAL: A total of 64 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462982

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Lauren E. Abrey, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: Paul B. Chapman, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: Robert J. Motzer, MD Memorial Sloan-Kettering Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: Memorial Sloan-Kettering Cancer Center ( Lauren E. Abrey )
Study ID Numbers: CDR0000539742, MSKCC-07009
Study First Received: April 18, 2007
Last Updated: October 23, 2008
ClinicalTrials.gov Identifier: NCT00462982  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
adult tumors metastatic to brain
stage IV renal cell cancer
recurrent melanoma
recurrent renal cell cancer

Study placed in the following topic categories:
Urogenital Neoplasms
Renal cancer
Central Nervous System Neoplasms
Kidney cancer
Urologic Neoplasms
Recurrence
Neuroendocrine Tumors
Melanoma
Carcinoma
Neuroectodermal Tumors
Urologic Diseases
Sunitinib
Kidney Neoplasms
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis
Carcinoma, Renal Cell
Neuroepithelioma
Nevus
Kidney Diseases
Adenocarcinoma
Urinary tract neoplasm
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Neoplasms, Nerve Tissue
Nervous System Diseases
Physiological Effects of Drugs
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Nevi and Melanomas
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 16, 2009