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Intravenous Palonosetron With Radiotherapy and Concomitant Temozolomide

This study has been completed.
Sponsor:
Collaborators:
Eisai Inc.
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00900757
First received: May 11, 2009
Last updated: November 3, 2014
Last verified: March 2014
Results First Received: December 30, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Malignant Glioma
Intervention: Drug: Palonosetron (PALO)

  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
Palonosetron

Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)

Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks.


Participant Flow:   Overall Study
    Palonosetron  
STARTED     57  
COMPLETED     38  
NOT COMPLETED     19  
screen failure                 19  



  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
Palonosetron

Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)

Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks.


Baseline Measures
    Palonosetron  
Number of Participants  
[units: participants]
  38  
Age  
[units: years]
Mean ± Standard Deviation
  58.9  ± 9.5  
Gender  
[units: participants]
 
Female     21  
Male     17  



  Outcome Measures
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1.  Primary:   Safety and Tolerability of Palonosetron as Determined by the Number of Participants Who Experience Unacceptable Toxicity   [ Time Frame: 6 weeks ]

2.  Secondary:   Complete Response   [ Time Frame: 6 weeks ]

3.  Secondary:   Change in the Functional Living Index - Emesis (FLIE) Score From Baseline to Each Week of Radiation (XRT) and Temozolomide (TMZ) Treatment   [ Time Frame: 6 weeks ]

4.  Secondary:   Percentage of Participants With a Osoba Nausea Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)   [ Time Frame: 6 weeks ]

5.  Secondary:   Percentage of Participants With a Osoba Vomiting/Retching Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)   [ Time Frame: 6 weeks ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Mary Lou Affronti
Organization: Duke University Medical Center
phone: 919-684-6239
e-mail: mary.affronti@dm.duke.edu


No publications provided


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00900757     History of Changes
Other Study ID Numbers: Pro00015573, P50NS020023
Study First Received: May 11, 2009
Results First Received: December 30, 2013
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board