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A Phase II Study of Pegylated Interferon Alfa 2b (PEG-Intron(Trademark)) in Children With Diffuse Pontine Gliomas

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ClinicalTrials.gov Identifier: NCT00036569
Recruitment Status : Completed
First Posted : May 13, 2002
Results First Posted : February 13, 2012
Last Update Posted : February 13, 2012
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Diffuse Intrinsic Pontine Glioma
Interventions: Procedure: adjuvant therapy
Biological: pegylated interferon alfa

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Interferon Alfa 0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.

Participant Flow:   Overall Study
    Interferon Alfa
STARTED   32 
COMPLETED   32 
NOT COMPLETED   0 



  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
  Description
Interferon Alfa 0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.

Baseline Measures
   Interferon Alfa 
Overall Participants Analyzed 
[Units: Participants]
 32 
Age 
[Units: Participants]
 
<=18 years   32 
Between 18 and 65 years   0 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 6.28  (3.16) 
Gender 
[Units: Participants]
 
Female   19 
Male   13 
Race/Ethnicity, Customized 
[Units: Participants]
 
Hispanic or Latino   2 
Not Hispanic or Latino   23 
Unknown or Not Reported   0 
Black   4 
Asian or Pacific Islander   2 
Native Hawaiian   1 
Region of Enrollment 
[Units: Participants]
 
United States   32 


  Outcome Measures

1.  Primary:   Two Year Survival of Pediatric Patients With Diffuse Pontine Gliomas   [ Time Frame: 8 yrs 6 mo 0 days ]

2.  Secondary:   Median Time to Progression   [ Time Frame: 8 yrs 11 mo 22 days ]

3.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 8 yrs 11 mo 22 days ]

4.  Secondary:   Mean Quality of Life (QOL) Score at Baseline and Follow-Up   [ Time Frame: once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria. ]

5.  Secondary:   Number of Participants With a Metabolic and Biological Change in the Brainstem Through Magnetic Resonance Imaging (MRI) Techniques   [ Time Frame: once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria. ]


  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
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  More Information

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: Kathy Warren, M.D.
Organization: National Cancer Institute
phone: 301-435-4683
e-mail: warrenk@mail.nih.gov


Publications:

Responsible Party: Katherine E. Warren, M.D./National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00036569     History of Changes
Obsolete Identifiers: NCT00041145
Other Study ID Numbers: 020193
02-C-0193
First Submitted: May 10, 2002
First Posted: May 13, 2002
Results First Submitted: September 20, 2011
Results First Posted: February 13, 2012
Last Update Posted: February 13, 2012