Immunotherapy of the Paraneoplastic Syndromes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00378326
First received: September 18, 2006
Last updated: January 26, 2016
Last verified: January 2016
Results First Received: November 2, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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
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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  
Number of Participants  
[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
Study First Received: September 18, 2006
Results First Received: November 2, 2015
Last Updated: January 26, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration