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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
Enrollment 32

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Interferon Alfa
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 32
Completed 32
Not Completed 0
Arm/Group Title Interferon Alfa
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
<=18 years
32
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants
6.28  (3.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
19
  59.4%
Male
13
  40.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants
32
1.Primary Outcome
Title Two Year Survival of Pediatric Patients With Diffuse Pontine Gliomas
Hide Description Survival is measured from the date the patient is registered onto the protocol until the day of death and the date of diagnosis to the date of patient death.
Time Frame 8 yrs 6 mo 0 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interferon Alfa
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: Percentage of patients
14.29
2.Secondary Outcome
Title Median Time to Progression
Hide Description Time between the final day of treatment to the day of disease progression.
Time Frame 8 yrs 11 mo 22 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interferon Alfa
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: Days
235
3.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Time Frame 8 yrs 11 mo 22 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interferon Alfa
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: Participants
32
4.Secondary Outcome
Title Mean Quality of Life (QOL) Score at Baseline and Follow-Up
Hide Description QOL questionnaires will be performed prior to every cycle for patients age 6-18 years and their parents until cycle 27 and then prior to every third cycle until cycle 52 when the evaluations will become annual. The QOL (NIH Impact of Pediatric Illness Scale) is too detailed to be described and/or shown here. It is a questionnaire made up of approximately 40 questions-the answers are ranked from 1 to 5 with 5 being no impact and 1 being significant impact-For further details see the protocol.
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title QOL Score at Baseline QOL Score at Follow-up
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 11 11
Mean (Standard Error)
Unit of Measure: Units on a scale
3.59  (0.11) 3.89  (0.11)
5.Secondary Outcome
Title Number of Participants With a Metabolic and Biological Change in the Brainstem Through Magnetic Resonance Imaging (MRI) Techniques
Hide Description MRI of the brain will be performed at the NCI prior to cycles 1, 2, 3, 5, 7, and continuing every other month until cycle 27. Following cycle 27 the patient will have an MRI performed every third cycle until cycle 52 at which time they will have an MRI performed annually, and when clinically indicated. Baseline MR images are compared with MR images performed during the various cycles (e.g. cycles 1, 2, 3...) Imaging was exploratory and the degree of change that is considered clinically significant rather than technique related is still being explored.
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interferon Alfa
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: Participants
32
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Interferon Alfa
Hide Arm/Group Description 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.
All-Cause Mortality
Interferon Alfa
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Interferon Alfa
Affected / at Risk (%) # Events
Total   32/32 (100.00%)    
Eye disorders   
Diplopia  1  3/32 (9.38%)  3
Gastrointestinal disorders   
Nausea  1  1/32 (3.13%)  1
Vomiting  1  1/32 (3.13%)  1
General disorders   
Fatigue  1  2/32 (6.25%)  2
Fever  1  1/32 (3.13%)  1
Infections and infestations   
Infection  1  1/32 (3.13%)  1
Investigations   
ALT  1  7/32 (21.88%)  8
Leukopenia  1  9/32 (28.13%)  16
Lymphopenia  1  9/32 (28.13%)  20
Neutropenia  1  12/32 (37.50%)  32
Nervous system disorders   
Ataxia  1  1/32 (3.13%)  1
Neuropathy-cranial  1  12/32 (37.50%)  42
Neuropathy-motor  1  3/32 (9.38%)  3
Pyramidal tract dysfunction  1  1/32 (3.13%)  1
Seizure  1  1/32 (3.13%)  1
Psychiatric disorders   
Insomnia  1  2/32 (6.25%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)/CTC2.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Interferon Alfa
Affected / at Risk (%) # Events
Total   32/32 (100.00%)    
Eye disorders   
Diplopia  1  0/32 (0.00%)  0
Gastrointestinal disorders   
Abdominal pain  1  1/32 (3.13%)  1
Nausea  1  1/32 (3.13%)  1
Vomiting  1  1/32 (3.13%)  1
General disorders   
Fatigue  1  3/32 (9.38%)  4
Fever  1  2/32 (6.25%)  2
Injection site reaction  1  2/32 (6.25%)  3
Infections and infestations   
Infection  1  0/32 (0.00%)  0
Injury, poisoning and procedural complications   
Bruising  1  3/32 (9.38%)  4
Investigations   
Alanine aminotransferase (ALT)  1  12/32 (37.50%)  24
Aspartate aminotransferase (AST)  1  7/32 (21.88%)  17
Bilirubin  1  2/32 (6.25%)  2
Hemoglobin  1  6/32 (18.75%)  26
Leukopenia  1  13/32 (40.63%)  41
Lymphopenia  1  9/32 (28.13%)  20
Neutropenia  1  8/32 (25.00%)  18
Thrombocytopenia  1  2/32 (6.25%)  2
Metabolism and nutrition disorders   
Anorexia  1  2/32 (6.25%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/32 (3.13%)  1
Nervous system disorders   
Ataxia  1  0/32 (0.00%)  0
Headache  1  2/32 (6.25%)  4
Neuropathy-cranial  1  0/32 (0.00%)  0
Neuropathy-motor  1  3/32 (9.38%)  4
Seizure  1  0/32 (0.00%)  0
Pyramidal tract dysfunction  1  9/32 (28.13%)  15
Psychiatric disorders   
Insomnia  1  1/32 (3.13%)  3
Personality change  1  1/32 (3.13%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)/CTC2.0
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
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