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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00462982 |
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 |
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Brain and Central Nervous System Tumors Kidney Cancer Melanoma (Skin) |
Drug: sunitinib malate |
Phase II |
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 |
Estimated Enrollment: | 64 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed melanoma or renal cell carcinoma
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
PATIENT CHARACTERISTICS:
No uncontrolled medical illness including, but not limited to, any of the following:
No systemic hemorrhage ≥ grade 2 within the past 4 weeks
No CNS hemorrhage ≥ grade 2
None of the following within the past 6 months:
PRIOR CONCURRENT THERAPY:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
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 |
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 |
stage IV melanoma adult tumors metastatic to brain stage IV renal cell cancer recurrent melanoma recurrent renal cell cancer |
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 |
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 |