Study of Platelet Derived Growth Factor Receptor (PDGFR) in Recurrent Malignant Gliomas
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|ClinicalTrials.gov Identifier: NCT01140568|
Recruitment Status : Terminated (Sponsor contract was not renewed by mutual decision of sponsor and PI.)
First Posted : June 9, 2010
Last Update Posted : October 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glioma||Drug: nilotinib||Phase 2|
Malignant gliomas (MG), including anaplastic gliomas (AG) and glioblastoma (GBM), are the most common primary brain tumor. Standard of care (surgery, radiotherapy, and temozolomide at initial diagnosis) results in a median survival of only 14 months. For patients with recurrent disease, conventional chemotherapy is generally ineffective with response rates <20%. Clearly there is need for improved treatments. Recent genome-wide studies have confirmed that GBM is a heterogeneous group of diseases that can be subclassified by shared genetic aberrations. The implication is that, in part, the underlying genetics may determine responsiveness to treatments and thus allow us to personalize therapy.
This is an, open-label, non-randomized, phase II study with oral nilotinib in adult patients with biomarker-enriched, recurrent malignant gliomas who have developed tumor progression after standard therapy. Patients will be treated with oral nilotinib (starting with the labeled dose of 400 mg) daily until disease progression or intolerance. One cycle is defined as 28 days.
Approximately 50 evaluable patients will be enrolled in this study, with 32 (grade IV) and 18 (grade III) in separate arms.
All patients will undergo clinical evaluation after each 28-day cycle. Neuroimaging studies (MRI) will be performed at baseline, 4 weeks, 8 weeks and then after every 2 cycles (8 weeks). If a contraindication for MRI's exists, patients will undergo contrast-enhanced CT scans. Laboratory tests will be obtained weekly during the first 4 weeks, and then on days 1 and 15 of all subsequent cycles. Patients will remain on study medication unless they develop tumor progression or unacceptable toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of PDGFR Kinase Inhibitor in Biomarker-Enriched Recurrent Malignant Gliomas|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||October 5, 2016|
|Actual Study Completion Date :||January 31, 2018|
Patients will take nilotinib twice daily at the standard dose of 400mg taken by mouth twice a day until disease progression or development of unacceptable side effects.
400mg po (orally) BID (twice daily)
Other Name: Tasigna
- To determine the efficacy of nilotinib in patients with recurrent malignant gliomas with PDGFR amplification as measured by 6-month progression-free survival. [ Time Frame: 6 months ]Use of a survival status check and radiologic assessments (MRI or CT brain scans) every 6 months to measure disease progression.
- To define the safety of nilotinib in this population based on frequency of adverse events leading to study discontinuation and number of significant laboratory abnormalities. [ Time Frame: 6 months ]Collection and assessment of side effect and abnormal lab assessment in relation to study participation.
- To characterize the pharmacokinetics of nilotinib in this population by serum and cerebrospinal fluid (CSF) examination of drug and metabolites. [ Time Frame: 6 months ]Collection and assessment of serum and CSF to examine the nilotinib drug concentrations in the body.
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): NCT01140568
|United States, California|
|The Rebecca and John Moores UCSD Cancer Center|
|La Jolla, California, United States, 92093|
|Principal Investigator:||David Piccioni, MD, PhD||University of California Medical Center|