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Study of PEG-Intron for Plexiform Neurofibromas

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00396019
First Posted: November 6, 2006
Last Update Posted: November 6, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jean M. Tersak, M.D., University of Pittsburgh
Results First Submitted: August 9, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Plexiform Neurofibroma
Intervention: Drug: PEG-Intron

  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
Stratum 1 No Symptom With or Withour Tumor Growth Peg-intron given every week
Stratum 2 Symptoms no Tumor Growth Peg-intron given every week
Stratum 3 Tumor Growth With or Without Symptoms Peg-intron given every week

Participant Flow:   Overall Study
    Stratum 1 No Symptom With or Withour Tumor Growth   Stratum 2 Symptoms no Tumor Growth   Stratum 3 Tumor Growth With or Without Symptoms
STARTED   27   29   30 
COMPLETED   27   26   29 
NOT COMPLETED   0   3   1 



  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.
No text entered.

Reporting Groups
  Description
Stratum 1 No Symptom With or Withour Tumor Growth Peg-intron given every week
Stratum 2 Symptoms no Tumor Growth Peg-intron given every week
Stratum 3 Tumor Growth With or Without Symptoms Peg-intron given every week
Total Total of all reporting groups

Baseline Measures
   Stratum 1 No Symptom With or Withour Tumor Growth   Stratum 2 Symptoms no Tumor Growth   Stratum 3 Tumor Growth With or Without Symptoms   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   26   29   82 
Age, Customized [1] 
[Units: Participants]
Count of Participants
       
Less than 5 years         
Participants Analyzed 
[Units: Participants]
 27   25   29   81 
Less than 5 years   3   8   9   20 
5 to 12 years         
Participants Analyzed 
[Units: Participants]
 27   25   29   81 
5 to 12 years   10   9   12   31 
greater than or equal to 12 years         
Participants Analyzed 
[Units: Participants]
 27   25   29   81 
greater than or equal to 12 years   14   8   8   30 
[1] Age data is missing for one subject.
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 0   0   0   0 
Female            0 
Male            0 
[1] Gender data was not captured with demographic/enrollment data.
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 0   0   0   0 
            0 
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
       
United States         
Participants Analyzed 
[Units: Participants]
 27   26   29   82 
United States   27   26   29   82 


  Outcome Measures
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1.  Primary:   Number of Participants With Imaging Response in Strata 1 and 2   [ Time Frame: MRI scans were performed at baseline and at months 4, 8, 12, 18, and 24 while on treatment and every 6 months thereafter until off study. ]

2.  Primary:   Clinical Response in Stratum 2   [ Time Frame: baseline, week 6, months 4, 8, 12, 18, and 24 while on treatment and every 6 months thereafter until off study ]

3.  Primary:   Time to Progression (TTP) in Stratum 3   [ Time Frame: baseline, week 6, months 4, 8, 12, 18, and 24 while on treatment and every 6 months thereafter until off study ]

4.  Secondary:   Number of Participants With Imaging Response in Stratum 3   [ Time Frame: MRI scans were performed at baseline and at months 4, 8, 12, 18, and 24 while on treatment and every 6 months thereafter until off study ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. Regina Jakacki
Organization: AstraZeneca
e-mail: regina.jakacki@astrazeneca.com


Publications of Results:

Responsible Party: Jean M. Tersak, M.D., University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00396019     History of Changes
Obsolete Identifiers: NCT00678951
Other Study ID Numbers: UPCI 06-116
First Submitted: November 2, 2006
First Posted: November 6, 2006
Results First Submitted: August 9, 2017
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017