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Trial record 52 of 578 for:    meningitis

Depocyt® With Sorafenib in Neoplastic Meningitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neoplastic Meningitis
Interventions Drug: DepoCyt
Drug: Sorafenib
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intrathecal DepoCyt and Oral Sorafenib
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 2
Completed 0
Not Completed 2
Reason Not Completed
Neither patient completed 8 weeks of tre             2
Arm/Group Title Intrathecal DepoCyt and Oral Sorafenib
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
2
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description 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.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Intrathecal DepoCyt and Oral Sorafenib
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
2
2.Secondary Outcome
Title Number of Participants With Progression Free Survival (PFS) at 6 Months
Hide Description 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.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
The study closed early due to low accrual of 2 of 10 expected patients. Neither patient completed 8 weeks of treatment as outlined in the protocol. Both patients expired before reaching the 6 month Progression Free Survival endpoint.
Arm/Group Title Intrathecal DepoCyt and Oral Sorafenib
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Participants With Overall Survival (OS)
Hide Description Several secondary endpoints were to be analyzed in a descriptive fashion. All patients were to be followed up until death.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
The study closed early due to low accrual of 2 of 10 expected patients. Neither patient completed 8 weeks of treatment as outlined in the protocol. Both patients expired before reaching the 6 month Progression Free Survival endpoint.
Arm/Group Title Intrathecal DepoCyt and Oral Sorafenib
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Sorafenib Levels in Cerebrospinal Fluid (CSF)
Hide Description 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.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
The study closed early due to low accrual of 2 of 10 expected patients. Neither patient completed 8 weeks of treatment as outlined in the protocol. Both patients expired before reaching the 6 month Progression Free Survival endpoint.
Arm/Group Title Intrathecal DepoCyt and Oral Sorafenib
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title CSF and Serum Vascular Endothelial Growth Factor (VEGF) Levels
Hide Description 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.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
The study closed early due to low accrual of 2 of 10 expected patients. Neither patient completed 8 weeks of treatment as outlined in the protocol. Both patients expired before reaching the 6 month Progression Free Survival endpoint.
Arm/Group Title Intrathecal DepoCyt and Oral Sorafenib
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 8 months
Adverse Event Reporting Description First On Study (9/10/09) to last Off Study (5/18/10)
 
Arm/Group Title Intrathecal DepoCyt and Oral Sorafenib
Hide Arm/Group Description 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.
All-Cause Mortality
Intrathecal DepoCyt and Oral Sorafenib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intrathecal DepoCyt and Oral Sorafenib
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Death not associated with CTCAE term - Death not otherwise specified (NOS)  1 [1]  1/2 (50.00%)  1
Death not associated with CTCAE term - Disease progression not otherwise specified (NOS)  1 [1]  1/2 (50.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC V3
[1]
Death occurred within 30 days. Unrelated to study treatment. Death not associated with Common Terminology Criteria for Adverse Events (CTCAE)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intrathecal DepoCyt and Oral Sorafenib
Affected / at Risk (%) # Events
Total   1/2 (50.00%)    
Blood and lymphatic system disorders   
Hemoglobin  1 [1]  1/2 (50.00%)  1
Edema: limb  1 [2]  1/2 (50.00%)  1
Cardiac disorders   
Hypotension  1 [1]  1/2 (50.00%)  1
Gastrointestinal disorders   
Anorexia  1 [2]  1/2 (50.00%)  1
Dehydration  1 [2]  1/2 (50.00%)  1
General disorders   
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L  1 [3]  1/2 (50.00%)  1
Infections and infestations   
Infection with unknown ANC-Mucosa  1 [4]  1/2 (50.00%)  1
Nervous system disorders   
Somnolence/depressed level of consciousness  1 [5]  1/2 (50.00%)  1
Cognitive disturbance  1 [6]  1/2 (50.00%)  1
Skin and subcutaneous tissue disorders   
Ulceration  1 [2]  1/2 (50.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC V3
[1]
Grade 1. Unrelated.
[2]
Grade 2. Unrelated.
[3]
Grade 1. Unrelated. Fever (in the absence of neutropenia, where neutropenia is defined as absolute neutrophil count (ANC) <1.0 x 10^9/L
[4]
Grade 1. Unrelated. Infection with unknown absolute neutrophil count (ANC)-Mucosa
[5]
Grade 1. Unrelated
[6]
Grade 3. Unrelated.
The study closed early due to low accrual of 2 of 10 expected patients. Neither patient completed 8 weeks of treatment as outlined in the protocol. Both patients expired before reaching the 6 month Progression Free Survival endpoint.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Edward Pan, M.D.
Organization: H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-3871
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00964743     History of Changes
Other Study ID Numbers: MCC-15783
Bayer IST000266 ( Other Identifier: Bayer )
First Submitted: August 24, 2009
First Posted: August 25, 2009
Results First Submitted: January 19, 2012
Results First Posted: April 19, 2012
Last Update Posted: September 9, 2013