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Trial record 14 of 578 for:    meningitis

DepoCyt for Active Lymphomatous or Leukemic 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: NCT00523939
Recruitment Status : Terminated (Low accrual.)
First Posted : September 3, 2007
Results First Posted : March 14, 2011
Last Update Posted : June 17, 2013
Sponsor:
Collaborator:
Enzon Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Neoplastic Meningitis
Lymphoma, B Cell
Intervention Drug: cytarabine liposome injection
Enrollment 4
Recruitment Details Recruitment June 2006 - September 2008. Study stopped early due to poor accrual.
Pre-assignment Details  
Arm/Group Title Lymphomatous Leukemic
Hide Arm/Group Description Subjects with Lymphomatous Meningitis Subjects with Leukemic Meningitis
Period Title: Overall Study
Started 2 2
Completed 2 2
Not Completed 0 0
Arm/Group Title Lymphomatous Leukemic Total
Hide Arm/Group Description Subjects with Lymphomatous Meningitis Subjects with Leukemic Meningitis Total of all reporting groups
Overall Number of Baseline Participants 2 2 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
2
 100.0%
4
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
2
 100.0%
2
 100.0%
4
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 2 participants 4 participants
2 2 4
1.Primary Outcome
Title Response Rate
Hide Description To evaluate response rate using intrathecal DepoCytTM in two cohorts of patients, one with active lymphomatous meningitis and another with active leukemic meningitis.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Primary outcome measure was not assessed due to early study termination.
Arm/Group Title Lymphomatous Leukemic
Hide Arm/Group Description:
Subjects with Lymphomatous Meningitis
Subjects with Leukemic Meningitis
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Time to Neurologic Progression
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lymphomatous Leukemic
Hide Arm/Group Description:
Subjects with Lymphomatous Meningitis
Subjects with Leukemic Meningitis
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Subjects
Hide Arm/Group Description Subjects with Lymphomatous or Leukemic Meningitis.
All-Cause Mortality
All Subjects
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Subjects
Affected / at Risk (%) # Events
Total   3/4 (75.00%)    
General disorders   
Death not associated with CTCAE term, disease progression * 1  1/4 (25.00%)  1
Infections and infestations   
Infection * 1  1/4 (25.00%)  2
Nervous system disorders   
Arachnoiditis * 1  1/4 (25.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Subjects
Affected / at Risk (%) # Events
Total   3/4 (75.00%)    
Blood and lymphatic system disorders   
Hemoglobin * 1  1/4 (25.00%)  1
Platelets * 1 [1]  2/4 (50.00%)  2
Gastrointestinal disorders   
Nausea * 1  1/4 (25.00%)  1
General disorders   
Fatigue * 1  1/4 (25.00%)  1
Pain * 1  1/4 (25.00%)  3
Edema * 1  1/4 (25.00%)  1
Metabolism and nutrition disorders   
hypocalcemia * 1  1/4 (25.00%)  1
Hyperglycemia * 1  1/4 (25.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Slurred speech * 1  1/4 (25.00%)  1
Acanthoma * 1  1/4 (25.00%)  1
Nervous system disorders   
Seizure * 1  1/4 (25.00%)  1
Tremor * 1 [2]  1/4 (25.00%)  1
Mood alteration * 1  2/4 (50.00%)  2
Psychiatric disorders   
Confusion * 1  1/4 (25.00%)  1
Renal and urinary disorders   
Urinary frequency * 1  2/4 (50.00%)  2
Skin and subcutaneous tissue disorders   
Rash * 1 [3]  1/4 (25.00%)  1
Vascular disorders   
DVT * 1  1/4 (25.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Thrombocytopenia
[2]
Possible seizure
[3]
Folliculitis
Adverse events for both arms, lymphomatous and leukemic, were combined due to low accrual and early study termination.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. David Rizzieri
Organization: Duke University Medical Center
Phone: 919-668-1040
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00523939     History of Changes
Other Study ID Numbers: Pro00009742
First Submitted: August 31, 2007
First Posted: September 3, 2007
Results First Submitted: February 16, 2011
Results First Posted: March 14, 2011
Last Update Posted: June 17, 2013