Vatalanib in Treating Patients With Recurrent or Progressive Meningioma
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|ClinicalTrials.gov Identifier: NCT00348790|
Recruitment Status : Completed
First Posted : July 6, 2006
Results First Posted : October 27, 2014
Last Update Posted : October 26, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Sarcoma||Drug: vatalanib||Phase 2|
- Determine the efficacy of vatalanib, in terms of radiographic improvement and clinical improvement, in patients with recurrent or progressive meningioma.
- Determine the 6-month progression-free survival of these patients.
- Describe the response rate and overall survival of these patients.
- Determine the safety of vatalanib in these patients.
- Correlate the response rates with expression of vascular endothelial growth factor, epidermal growth factor receptor, platelet-derived growth factor, and HER2.
- Develop exploratory data concerning surrogate markers of angiogenic activity in vivo using magnetic resonance perfusion.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of PTK-787 in Recurrent or Progressive Meningiomas|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||July 2013|
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.
- Number of Patients Who DID NOT Experience Disease Progression or Death by 6 Months After Starting Treatment. [ Time Frame: 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 ]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.
- Determine Efficacy (Radiographic and Clinical Improvement) [ Time Frame: At baseline, every 2 weeks for 2 months, then every 8 weeks while on treatment ]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
- Best Overall Response Rate (ORR) [ Time Frame: Every 2 months for up to 1 year after study treatment. ]
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
- To Correlate the Response Rates With Expression of Certain Types of Genes [ Time Frame: At the end of study treatment ]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
- Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas [ Time Frame: Every week while on study treatment until 30 days after last treatment. ]
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
- Number of Months Patients Survive After Being Treatment on the Study. [ Time Frame: From the date the first patient began treatment until the date the last patient became deceased. ]
- Overall Survival (OS) [ Time Frame: Every 2 months for up to 1 year after study treatment. ]Overall Survival will be measured from the first treatment on study until death of any cause.
- Develop Data Concerning Certain Genes That Cause Tumors to Grow New Blood Vessels [ Time Frame: MRI with MR Perfusion will be done before treatment and then every 2 months while on study treatment ]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
- To Use the FACT BR Questionnaire to Measure Quality of Life [ Time Frame: At baseline and then every time an MRI is performed while on study treatment. ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348790
|United States, Illinois|
|Hematology-Oncology Associates of Illinois|
|Chicago, Illinois, United States, 60611-2998|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|United States, Washington|
|University Cancer Center at University of Washington Medical Center|
|Seattle, Washington, United States, 98195-6043|
|Principal Investigator:||Jeffrey J. Raizer, MD||Northwestern University|