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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
| University of Virginia | OTHER |
| University of Pittsburgh | OTHER |
| Pfizer |
The purpose of this study is to find out what effects, good and/or bad, sunitinib has on patients and their tumors. At this time, no drugs are routinely used to treat meningioma, hemangioblastoma or hemangiopericytoma. Only surgery and radiation therapy are known to be useful.
Sunitinib is a drug approved for advanced kidney cancer. Sunitinib is also being studied for other tumors. It may be useful in the treatment of brain tumors because it can prevent formation of new blood vessels that allow tumor cells to survive and grow.
This is a phase II study of Sunitinib in patients with recurrent or inoperable meningiomas. An exploratory study will be performed for patients with recurrent hemangiopericytoma or hemangioblastoma. There will be approximately 50 patients enrolled on this study (40 meningiomas and 10 hemangiopericytomas/hemangioblastomas). The treatment plan is to use daily SU11248 at a dose of 50 mg, using the established schedule of 4 weeks of treatment followed by two weeks of rest period, forming a six-week treatment cycle. A medical professional will see each patient at least every six weeks while on the medication for toxicity assessment and physical examination. Extent of disease evaluations will occur at baseline, two weeks, twelve weeks, 24 weeks, and every twelve weeks thereafter. These evaluations will include MRI of the brain (or CT head if a patient cannot undergo MRI) and MR perfusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Sunitinib will be administered at a dose of 50 mg orally once daily for four consecutive weeks, followed by a two-week rest period. Intra-patient dose reduction may be required depending on the type and severity of individual toxicity encountered. Imaging studies will be performed after every other cycle. Patients may continue on study as long as they are tolerating treatment and in the absence of disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib | Drug | The study drug will be administered on an outpatient basis. The starting dose will be 50 mg daily for 28 days (4 consecutive weeks) followed by 14 days off for patients not on CYP3A4 inducers or inhibitors. A cycle equals 42 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Objective Response | Determine the overall objective response | 1.5 years |
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Inclusion Criteria:
Absolute neutrophil count (ANC) ≥ 1,000/mm3
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Kaley, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States | ||
| Memoral Sloan Kettering Cancer Center |
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| Label | URL |
|---|---|
| Memorial Sloan-Kettering web site | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aggressive Memingioma | Patients with Aggressive Memingioma |
| FG001 | Exploratory Cohort | Patients with WHO grade I meningioma, HPC and hemangioblastoma |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| INDUSTRY |
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|
| Basking Ridge |
| New Jersey |
| United States |
| Memorial Sloan-Kettering Cancer Center at Commack | Commack | New York | 11725 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States |
| University of Virginia Health Science Center | Charlottesville | Virginia | 22908 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aggressive Memingioma | Patients with Aggressive Memingioma |
| BG001 | Exploratory Cohort | Patients with WHO grade I meningioma, HPC and hemangioblastoma |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Overall Objective Response | Determine the overall objective response | Posted | Number | participants | 1.5 years |
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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 | All Patients | All patients treated with Sunitinib (SU011248) | 27 | 50 | 50 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CNS Hemorrhage | Nervous system disorders | CTC-3.0 | Systematic Assessment |
| |
| Thrombic Microangiopathy | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| Fatigue | General disorders | CTC-3.0 | Systematic Assessment |
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| Thrombocytopenia | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Lueukopenia | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTC-3.0 | Systematic Assessment |
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| Headache | General disorders | CTC-3.0 | Systematic Assessment |
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| ALT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| AST | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Dehydration | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
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| Pain | General disorders | CTC-3.0 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| Rash, Hand-Foot Reaction | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| Confusion | Nervous system disorders | CTC-3.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
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| Creatinine | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| Prolonged QTc Interval | Cardiac disorders | CTC-3.0 | Systematic Assessment |
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| Right Ventricular Enlargement | Cardiac disorders | CTC-3.0 | Systematic Assessment |
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| Thrombosis/ Embolism | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
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| Hyperuricemia | Renal and urinary disorders | CTC-3.0 | Systematic Assessment |
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| Gastrointestinal Perforation | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Fatigue | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Thrombocytopenia | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| AST | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| ALT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Rash, Hand-Foot Reaction | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
| |
| Mucositis | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Dysgeusia | General disorders | CTC-3.0 | Systematic Assessment |
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| Headache | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
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| Hypertension | Cardiac disorders | CTC-3.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Kaley | Memorial Sloan Kettering Cancer Center | 212-639-5122 | KaleyT@mskcc.org |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D008579 | Meningioma |
| D018325 | Hemangioblastoma |
| D017253 | Neurofibromatoses |
| D001932 | Brain Neoplasms |
| D009456 | Neurofibromatosis 1 |
| D016518 | Neurofibromatosis 2 |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |
| D018324 | Hemangioma, Capillary |
| D006391 | Hemangioma |
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D020752 | Neurocutaneous Syndromes |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009464 | Neuroma, Acoustic |
| D009442 | Neurilemmoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009463 | Neuroma |
| D000160 | Vestibulocochlear Nerve Diseases |
| D012181 | Retrocochlear Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010039 | Otorhinolaryngologic Neoplasms |
| D003390 | Cranial Nerve Neoplasms |
| D003389 | Cranial Nerve Diseases |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Male |
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| Progression of Disease |
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| Stable Disease |
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