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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA008748 | U.S. NIH Grant/Contract | View source | |
| MSKCC-07009 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunitinib | Experimental | Patients will be treated with 50 mg daily for four out of every six weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sunitinib malate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Central Nervous System (CNS) Response Rate by RECIST Criteria | Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques (CT, MRI, X-ray) or as >10 mm with spiral CT scan. This study will use a minimum diameter of 10 mm for measurable lesions in the brain, regardless of imaging modality. All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). All other lesions are considered non-measurable disease. Bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, inflammatory breast disease, and cystic lesions are all nonmeasurable. | up to a year |
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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
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:
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
None of the following within the past 6 months:
Ejection fraction ≥ 50% by baseline echocardiogram OR < 20% decrease in ejection fraction from a prior study
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sunitinib | Patients will be treated with 50 mg daily for four out of every six weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib | Patients will be treated with 50 mg daily for four out of every six weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Central Nervous System (CNS) Response Rate by RECIST Criteria | Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques (CT, MRI, X-ray) or as >10 mm with spiral CT scan. This study will use a minimum diameter of 10 mm for measurable lesions in the brain, regardless of imaging modality. All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). All other lesions are considered non-measurable disease. Bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, inflammatory breast disease, and cystic lesions are all nonmeasurable. | Posted | Number | participants | up to a year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sunitinib | Patients will be treated with 50 mg daily for four out of every six weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT, SGPT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT, SGPT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Motzer | Memorial Sloan Kettering Cancer Center | 646-422-4312 | motzerr@mskcc.org |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D008545 | Melanoma |
| D009362 | Neoplasm Metastasis |
| D001932 | Brain Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Patients will be treated with 50 mg daily for four out of every six weeks. |
|
|
| 4 |
| 8 |
| 6 |
| 8 |
| AST, SGOT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Death not assoc w CTCAE term-Disease prog NOS | General disorders | CTC-3.0 | Systematic Assessment |
|
| Pain - Head/headache | General disorders | CTC-3.0 | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Speech impairment | Nervous system disorders | CTC-3.0 | Systematic Assessment |
|
| Thrombosis/thrombus/embolism | Cardiac disorders | CTC-3.0 | Systematic Assessment |
|
| AST, SGOT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Albumin, low (hypoalbuminemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Metabolic/Lab - Other | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Neuropathy: sensory | Nervous system disorders | CTC-3.0 | Systematic Assessment |
|
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |