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Trial record 59 of 295 for:    IFNA2 AND PEG-interferon alfa-2b

Phase II Trial of Peginterferon Alpha-2b and Thalidomide in Adults With Recurrent Gliomas

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.
 
ClinicalTrials.gov Identifier: NCT00047879
Recruitment Status : Completed
First Posted : October 23, 2002
Results First Posted : October 26, 2011
Last Update Posted : October 26, 2011
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Glioma
Interventions Biological: PEG-interferon alfa-2b
Drug: Thalidomide
Enrollment 7
Recruitment Details

We planned to accrue 32 patients to the GBM stratum and 32 patients to the AG stratum.

The accrual ceiling was 64 patients on this trial. We anticipated accruing these patients within one year of opening this study.

Pre-assignment Details  
Arm/Group Title Glioblastoma Multiforme Stratum Anaplastic Glioma Stratum
Hide Arm/Group Description Glioblastoma multiforme is one of the most common and aggressive types of brain tumor. Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
Period Title: Overall Study
Started 4 3
Completed 0 0
Not Completed 4 3
Reason Not Completed
Progressive disease             4             3
Arm/Group Title Glioblastoma Multiforme Stratum Anaplastic Glioma Stratum Total
Hide Arm/Group Description Glioblastoma multiforme is one of the most common and aggressive types of brain tumor. Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy. Total of all reporting groups
Overall Number of Baseline Participants 4 3 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
1
  33.3%
5
  71.4%
>=65 years
0
   0.0%
2
  66.7%
2
  28.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 7 participants
55.5  (10.85) 53.67  (11.93) 54.71  (10.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
Female
0
   0.0%
1
  33.3%
1
  14.3%
Male
4
 100.0%
2
  66.7%
6
  85.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 3 participants 7 participants
4 3 7
1.Primary Outcome
Title Progression-free Survival
Hide Description

Progression free survival is defined as the percent of patients that are progression free and alive 6 months after initiating therapy.

Progression of disease by > 50% increase in the size of the tumor compared to baseline after the first cycle only, and then >25% increase in the size of the tumor for all subsequent cycles.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The primary objective was not met. Only registered 7 out of 64 participants and they all came off the study for progressive disease around 3-4 months after starting the study. None of the participants were evaluated for progression-free survival at 6 months because the study was stopped at 4 months due to progressive disease.
Arm/Group Title Glioblastoma Multiforme Stratum Anaplastic Glioma Stratum
Hide Arm/Group Description:
Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Participants With Complete or Partial Response
Hide Description

Response is defined per RECIST criteria. Measurable disease is defined as bidimensionally measurable lesions with clearly defined margins by CT or MRI scan.

Evaluable disease is defined as unidimensionally measurable lesions, masses with margins not clearly defined, or lesions with a multiple cystic component.

Complete response (CR) is complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to 50% decrease under baseline in the sum of products or perpendicular diameters of all measurable lesions.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Registered 7 out of 64 participants and they came off study for progressive disease around 3-4 months after starting the study.
Arm/Group Title Glioblastoma Multiforme Stratum Anaplastic Glioma Stratum
Hide Arm/Group Description:
Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title The Number of Participants With Adverse Events
Hide Description Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glioblastoma Multiforme Stratum Anaplastic Glioma Stratum
Hide Arm/Group Description:
Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
Overall Number of Participants Analyzed 4 3
Measure Type: Number
Unit of Measure: Participants
4 2
Time Frame 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Glioblastoma Multiforme Stratum Anaplastic Glioma Stratum
Hide Arm/Group Description Glioblastoma multiforme is one of the most common and aggressive types of brain tumor. Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
All-Cause Mortality
Glioblastoma Multiforme Stratum Anaplastic Glioma Stratum
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Glioblastoma Multiforme Stratum Anaplastic Glioma Stratum
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/4 (75.00%)      2/3 (66.67%)    
Gastrointestinal disorders     
Nausea  1  0/4 (0.00%)  0 1/3 (33.33%)  1
Vomiting  1  0/4 (0.00%)  0 1/3 (33.33%)  1
Investigations     
Thrombocytopenia  1  0/4 (0.00%)  0 1/3 (33.33%)  1
Elevated AST  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Metabolism and nutrition disorders     
Metabolic, hyperglycemia  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle weakness  1  0/4 (0.00%)  0 1/3 (33.33%)  1
Nervous system disorders     
Headache  1  0/4 (0.00%)  0 1/3 (33.33%)  1
Seizure  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA10/CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Glioblastoma Multiforme Stratum Anaplastic Glioma Stratum
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      2/3 (66.67%)    
Gastrointestinal disorders     
Nausea  1  1/4 (25.00%)  1 0/3 (0.00%)  0
General disorders     
edema: limb right upper extremity  1  0/4 (0.00%)  0 1/3 (33.33%)  1
Fatigue  1  2/4 (50.00%)  3 0/3 (0.00%)  0
Fever  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Infections and infestations     
Infection  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Investigations     
Thrombocytopenia  1  0/4 (0.00%)  0 1/3 (33.33%)  1
Metabolic, ALT elevated  1  1/4 (25.00%)  1 0/3 (0.00%)  0
AST  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Glucose  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Elevated AST  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Elevated bilirubin  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Musculoskeletal, other leg/foot cramp  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Nervous system disorders     
Dizziness  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Pain, skin  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Neurology, somnolence  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Psychiatric disorders     
Mood alteration  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Confusion  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dry skin  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Rash  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA10/CTCAE (3.0)
Registered 7 out of 64 participants and they came off study for progressive disease around 3-4 months after starting the study.
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
Layout table for Results Point of Contact information
Name/Title: Howard A. Fine, M.D.
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-402-6383
EMail: hfine@mail.nih.gov
Layout table for additonal information
Responsible Party: Howard A. Fine, M.D./National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00047879     History of Changes
Obsolete Identifiers: NCT00052650
Other Study ID Numbers: 030002
03-C-0002 ( Other Identifier: Clinical Center (CC), National Institutes of Health (NIH) )
030002 ( Other Identifier: Clinical Center (CC), National Institutes of Health (NIH) )
First Submitted: June 19, 2006
First Posted: October 23, 2002
Results First Submitted: May 24, 2011
Results First Posted: October 26, 2011
Last Update Posted: October 26, 2011