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Immunotherapy of the Paraneoplastic Syndromes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00378326
First Posted: September 20, 2006
Last Update Posted: February 23, 2016
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.
Information provided by (Responsible Party):
Rockefeller University
Results First Submitted: November 2, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Paraneoplastic Syndromes
Intervention: Drug: Tacrolimus

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Tacrolimus Tacrolimus at doses of 0.15- 0.3mg/kg/day in two divided oral doses, in conjunction with, initially, up to 60mg/day of oral prednisone

Participant Flow:   Overall Study
    Tacrolimus
STARTED   26 
COMPLETED   26 
NOT COMPLETED   0 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Tacrolimus Tacrolimus at doses of 0.15- 0.3mg/kg/day in two divided oral doses, in conjunction with, initially, up to 60mg/day of oral prednisone

Baseline Measures
   Tacrolimus 
Overall Participants Analyzed 
[Units: Participants]
 26 
Age 
[Units: Years]
Median (Full Range)
 59.5 
 (31 to 78) 
Gender 
[Units: Participants]
 
Female   25 
Male   1 


  Outcome Measures
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1.  Primary:   Survival of Patients With Paraneoplastic Disease Who Are Treated With Tacrolimus   [ Time Frame: through study completion, median 3 years of follow up ]

2.  Secondary:   Cerebrospinal Fluid (CSF) Pleocytosis   [ Time Frame: White blood cell count in CSF was measured at two time points, pre- and post-treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Robert B. Darnell, MD, PhD
Organization: Rockefeller University
phone: 212-327-7474
e-mail: darnelr@rockefeller.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00378326     History of Changes
Other Study ID Numbers: RDA-0572
First Submitted: September 18, 2006
First Posted: September 20, 2006
Results First Submitted: November 2, 2015
Results First Posted: February 23, 2016
Last Update Posted: February 23, 2016