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| ID | Type | Description | Link |
|---|---|---|---|
| STU00005338 | Other Identifier | Northwestern University IRB | |
| NU 05C4 | Other Identifier | Northwestern University |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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RATIONALE: Vatalanib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well vatalanib works in treating patients with recurrent or progressive meningioma.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral vatalanib twice daily on days 1-28. Courses repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 1 year.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vatalanib | Experimental | Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached. Patients who are responding may remain on study treatment for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vatalanib | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who DID NOT Experience Disease Progression or Death by 6 Months After Starting Treatment. | Patients were assessed with imaging techniques (MRI) during screening/baseline and then every 2 months after starting treatment. Survival status and disease status were recorded. The number of patients who did not experience an event (defined as either death for any reason or progression of their disease) by 6 months after starting treatment were counted. | From the date the first patient began treatment until the date the last patient has disease progression, becomes deceased, or completes 6 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Determine Efficacy (Radiographic and Clinical Improvement) | Efficacy will be assessed by MRI scan and neurological exam upon study entry, every 2 weeks for 2 months, then every 8 weeks while on treatment | At baseline, every 2 weeks for 2 months, then every 8 weeks while on treatment |
| Best Overall Response Rate (ORR) |
| Measure | Description | Time Frame |
|---|---|---|
| Develop Data Concerning Certain Genes That Cause Tumors to Grow New Blood Vessels | Data concerning certain genes that cause tumors to grow new blood vessels will be examined by MRI scan with MR Perfusion done before treatment and then every 2 months while on study treatment | MRI with MR Perfusion will be done before treatment and then every 2 months while on study treatment |
DISEASE CHARACTERISTICS:
Histologically confirmed meningioma, including the following subtypes:
Benign meningioma
Malignant meningioma
Atypical meningiomas
Hemangiopericytoma
May or may not have neurofibromatosis (NF) type 1 or 2 disease
Progressive or recurrent disease by MRI or CT scan
Recent resection of recurrent or progressive tumor allowed provided both of the following criteria are met:
PATIENT CHARACTERISTICS:
Karnofsky performance status 60-100%
Life expectancy > 12 weeks
Absolute neutrophil count ≥ 2,000/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 10 g/dL (transfusion allowed)
SGOT and SGPT < 2 times upper limit of normal (ULN)
Bilirubin ≤ 1.5 times ULN
Creatinine < 1.5 mg/dL
Negative proteinuria dipstick OR total urinary protein ≤ 500 mg AND creatinine clearance ≥ 50 mL/min
PT, INR, and PTT ≤ 1.5 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for up to 6 months after completion of study treatment
No history of any other cancer except nonmelanoma skin cancer or carcinoma in situ of the cervix, unless in complete remission and off all therapy for that disease for ≥ 3 years
No disease that would obscure toxicity or dangerously alter drug metabolism
No bleeding disorders
No severe and/or uncontrolled medical conditions that would limit compliance with study requirements, including any of the following:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey J. Raizer, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology-Oncology Associates of Illinois | Chicago | Illinois | 60611-2998 | United States | ||
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vatalanib | Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached. Patients who are responding may remain on study treatment for 12 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Began Treatment |
| |||||||||||||
| Completed Treatment |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vatalanib | Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached. Patients who are responding may remain on study treatment for 12 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Number of Patients Who DID NOT Experience Disease Progression or Death by 6 Months After Starting Treatment. | Patients were assessed with imaging techniques (MRI) during screening/baseline and then every 2 months after starting treatment. Survival status and disease status were recorded. The number of patients who did not experience an event (defined as either death for any reason or progression of their disease) by 6 months after starting treatment were counted. | Posted | Count of Participants | Participants | From the date the first patient began treatment until the date the last patient has disease progression, becomes deceased, or completes 6 months of treatment |
|
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Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
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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 | Vatalanib | Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached. Patients who are responding may remain on study treatment for 12 months. vatalanib |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Jaw pain | Musculoskeletal and connective tissue disorders | CTCAE version 3 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Raizer, MD | Northwestern University | 312-503-4724 | jraizer@nmff.org |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D012509 | Sarcoma |
| D008579 | Meningioma |
| C562740 | Hemangiopericytoma, Malignant |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C404768 | vatalanib |
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Overall Response Rate (ORR) will be as assessed by MRI scan every 2 months while on study treatment and follow-up for up to 1 year after discontinuation of study treatment. The RR is the best response recorded from the start of the treatment until disease progression (PD) where the following definitions apply. Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Stable/No Response: Does not qualify for CR, PR, or PD Progressive disease (PD):25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) worsening of evaluable disease, new lesions, clinical worsening OR failure to return for evaluation due to death/deteriorating condition |
| Every 2 months for up to 1 year after study treatment. |
| To Correlate the Response Rates With Expression of Certain Types of Genes | Correlation of response rates with the expression of certain types of genes will be assessed by examining tissue samples taken from previous surgery and testing for certain genes | At the end of study treatment |
| Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas | Safety of vatalanib will be assessed using National Cancer Institute Common Terminology Criteria of Adverse Events (NCI CTCAE) 3.0 and graded using the following: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Fatal | Every week while on study treatment until 30 days after last treatment. |
| Number of Months Patients Survive After Being Treatment on the Study. | From the date the first patient began treatment until the date the last patient became deceased. |
| Overall Survival (OS) | Overall Survival will be measured from the first treatment on study until death of any cause. | Every 2 months for up to 1 year after study treatment. |
| To Use the FACT BR Questionnaire to Measure Quality of Life | FACT BR questionnaire will be used to measure quality of life at baseline and then every time an MRI scan is performed while on study treatment | At baseline and then every time an MRI is performed while on study treatment. |
| Chicago |
| Illinois |
| 60611-3013 |
| United States |
| University Cancer Center at University of Washington Medical Center | Seattle | Washington | 98195-6043 | United States |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Determine Efficacy (Radiographic and Clinical Improvement) | Efficacy will be assessed by MRI scan and neurological exam upon study entry, every 2 weeks for 2 months, then every 8 weeks while on treatment | Data not collected. Statistical design of study was based on participation of patients with WHO grade I meningioma. Most patients enrolled in the study were WHO grade II and WHO grade III. | Posted | At baseline, every 2 weeks for 2 months, then every 8 weeks while on treatment |
|
|
| Secondary | Best Overall Response Rate (ORR) | Overall Response Rate (ORR) will be as assessed by MRI scan every 2 months while on study treatment and follow-up for up to 1 year after discontinuation of study treatment. The RR is the best response recorded from the start of the treatment until disease progression (PD) where the following definitions apply. Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Stable/No Response: Does not qualify for CR, PR, or PD Progressive disease (PD):25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) worsening of evaluable disease, new lesions, clinical worsening OR failure to return for evaluation due to death/deteriorating condition | 3 patients not evaluable. | Posted | Count of Participants | Participants | Every 2 months for up to 1 year after study treatment. |
|
|
|
| Secondary | To Correlate the Response Rates With Expression of Certain Types of Genes | Correlation of response rates with the expression of certain types of genes will be assessed by examining tissue samples taken from previous surgery and testing for certain genes | Data not collected and analyzed. | Posted | At the end of study treatment |
|
|
| Secondary | Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas | Safety of vatalanib will be assessed using National Cancer Institute Common Terminology Criteria of Adverse Events (NCI CTCAE) 3.0 and graded using the following: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Fatal | Toxicities determined to be either grade 3 or grade 4 and at least possibly related to study drug are reported here. | Posted | Number | participants | Every week while on study treatment until 30 days after last treatment. |
|
|
|
| Secondary | Number of Months Patients Survive After Being Treatment on the Study. | Posted | Median | 95% Confidence Interval | months | From the date the first patient began treatment until the date the last patient became deceased. |
|
|
|
| Secondary | Overall Survival (OS) | Overall Survival will be measured from the first treatment on study until death of any cause. | Number of patients with WHO grade II or WHO grade III meningioma. | Posted | Median | Full Range | Months | Every 2 months for up to 1 year after study treatment. |
|
|
|
| Other Pre-specified | Develop Data Concerning Certain Genes That Cause Tumors to Grow New Blood Vessels | Data concerning certain genes that cause tumors to grow new blood vessels will be examined by MRI scan with MR Perfusion done before treatment and then every 2 months while on study treatment | Data not collected and analyzed. | Posted | MRI with MR Perfusion will be done before treatment and then every 2 months while on study treatment |
|
|
| Other Pre-specified | To Use the FACT BR Questionnaire to Measure Quality of Life | FACT BR questionnaire will be used to measure quality of life at baseline and then every time an MRI scan is performed while on study treatment | Data not collected or analyzed. | Posted | At baseline and then every time an MRI is performed while on study treatment. |
|
|
| 6 |
| 25 |
| 23 |
| 25 |
| Dehydration | Metabolism and nutrition disorders | CTCAE version 3 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE version 3 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE version 3 | Non-systematic Assessment | Subject was admitted for elective craniotomy. Subject went into atrial fibrillation unrelated to study drug. |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE version 3 | Non-systematic Assessment |
|
| Scalp wound | Skin and subcutaneous tissue disorders | CTCAE version 3 | Non-systematic Assessment | Subject was admitted after falling with scalp wound. The injury was unrelated to study treatment. |
|
| Vertigo | Ear and labyrinth disorders | CTCAE version 3 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE version 3 | Non-systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy: Sensory-facial | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy - Motor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Transaminase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alkaline phosphatase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Creatinine | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
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| T wave abnormalities/changes | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Thrombosis/embolism (vascular access-related) | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vision loss | Eye disorders | CTCAE (3.0) | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Proteinuria | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Memory impairment | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Spasm | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Confusion | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D018204 |
| Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Gastrointestinal |
|
| Hypertension |
|
| Hyponatremia |
|
| Leukopenia |
|
| Pain |
|
| Rash |
|
| Transaminase |
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| Weight loss |
|