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. Identifier: NCT00523939
Recruitment Status : Terminated (Low accrual.)
First Posted : September 3, 2007
Results First Posted : March 14, 2011
Last Update Posted : June 17, 2013
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment June 2006 - September 2008. Study stopped early due to poor accrual.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Lymphomatous Subjects with Lymphomatous Meningitis
Leukemic Subjects with Leukemic Meningitis

Participant Flow:   Overall Study
    Lymphomatous   Leukemic
STARTED   2   2 
COMPLETED   2   2 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Lymphomatous Subjects with Lymphomatous Meningitis
Leukemic Subjects with Leukemic Meningitis
Total Total of all reporting groups

Baseline Measures
   Lymphomatous   Leukemic   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   2   4 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   2   2   4 
>=65 years   0   0   0 
[Units: Participants]
Female   0   0   0 
Male   2   2   4 
Region of Enrollment 
[Units: Participants]
United States   2   2   4 

  Outcome Measures

1.  Primary:   Response Rate   [ Time Frame: 1 year ]

2.  Secondary:   Time to Neurologic Progression   [ Time Frame: 2 years ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Adverse events for both arms, lymphomatous and leukemic, were combined due to low accrual and early study termination.

  More Information

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 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