Depocyt® With Sorafenib in Neoplastic Meningitis
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|ClinicalTrials.gov Identifier: NCT00964743|
Recruitment Status : Terminated (Low Accrual)
First Posted : August 25, 2009
Results First Posted : April 19, 2012
Last Update Posted : September 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Neoplastic Meningitis||Drug: DepoCyt Drug: Sorafenib||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm Pilot Study of Intrathecally Administered DepoCyt® With Systemic Sorafenib in the Treatment of Neoplastic Meningitis From Solid Tumors|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
Experimental: Intrathecal DepoCyt and Oral Sorafenib
This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
Patients were to receive DepoCyt through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses.
Patients received oral sorafenib at 400 mg twice a day
- Number of Participants With Adverse Events (AEs) [ Time Frame: 6 Months ]Safety and tolerability of sorafenib with DepoCyt. Toxicities were to be reported using tables and descriptive statistics by type and grade. All patients were to be followed up until death.
- Number of Participants With Progression Free Survival (PFS) at 6 Months [ Time Frame: 6 Months ]Kaplan-Meier analysis of PFS was to be performed and the PFS at 6 months in the study patients were be empirically described. All patients were to be followed up until death.
- Number of Participants With Overall Survival (OS) [ Time Frame: 6 Months ]Several secondary endpoints were to be analyzed in a descriptive fashion. All patients were to be followed up until death.
- Sorafenib Levels in Cerebrospinal Fluid (CSF) [ Time Frame: 6 Months ]CSF sorafenib level was to be measured over time, and the means and standard errors of the sorafenib level were to be plotted at specific sampling time points. CSF sorafenib levels may also have been correlated with patients' PFS, OS, or cytology using descriptive statistical methods (e.g., KM analysis stratified by high vs. low CSF sorafenib levels). The log transformation of lab values were to be employed on the continuous variables whenever necessary.
- CSF and Serum Vascular Endothelial Growth Factor (VEGF) Levels [ Time Frame: 6 Months ]CSF and serum VEGF levels were to be measured over time, and the means and standard errors of the respective VEGF levels were to be plotted at specific sampling time points. The respective VEGF levels may also have been correlated with patients' PFS, OS, or cytology using descriptive statistical methods similarly as mentioned above. The log transformation of lab values were to be employed on the continuous variables whenever necessary.
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): NCT00964743
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Edward Pan, M.D.||H. Lee Moffitt Cancer Center and Research Institute|