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Trial record 1 of 27 for:    PEG interferon alpha 2b melanoma
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PEG-Interferon Alfa-2b in Treating Patients With Stage IV Melanoma

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ClinicalTrials.gov Identifier: NCT00049530
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : June 3, 2014
Last Update Posted : October 28, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Melanoma (Skin)
Intervention Biological: PEG-interferon alfa-2b
Enrollment 32
Recruitment Details This study was activated on September 5, 2003, and patient accrual was terminated on June 15, 2011. A total of 32 patients were enrolled through ECOG member institutions. The study was suspended three times during the accrual period (February 2005, November 2006, January 2009) due to unavailability of ELISA kits to measure fibroblast growth factor.
Pre-assignment Details This study involves a pre-registration and a registration. In the pre-registration phase, plasma samples must be submitted for determinations of b-FGF status by central analysis. Only patients determined to have an elevated b-FGF level (>15 pg/mL) by central review are eligible for registration.
Arm/Group Title PEG-interferon Alfa-2b
Hide Arm/Group Description Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 32
Eligible and Treated 29
Completed 0
Not Completed 32
Reason Not Completed
Lack of Efficacy             25
Adverse Event             2
Death             1
symptomatic deterioration             1
ineligible             3
Arm/Group Title PEG-Interferon Alfa-2b
Hide Arm/Group Description Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
The primary analysis population was all eligible (meeting all eligibility criteria listed in protocol) and treated patients (receiving at least one dose of the protocol therapy). All baseline analysis and efficacy endpoints are based on the primary population (n=29).
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 29 participants
64
(39 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
9
  31.0%
Male
20
  69.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants
32
1.Primary Outcome
Title Plasma b-FGF Level Response
Hide Description The primary endpoint was the suppression of plasma b-FGF level with low dose peginterferon alfa-2b. A clinically important reduction of plasma b-FGF levels was determined to be a level less than or equal to 7.5 pg/mL. A patient was considered to have a suppressed plasma b-FGF level, if the patient experienced the clinically significant reduction (less than or equal to 7.5 pg/mL) of plasma b-FGF levels for two consecutive determinations which were at least three weeks apart. This was considered as a b-FGF response.
Time Frame assessed every 3 weeks until the suppression of plasma b-FGF level to normal, then every 6 weeks until the completion of 12 months of treatment, and upon treatment discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
eligible and treated patients
Arm/Group Title PEG-interferon Alfa-2b
Hide Arm/Group Description:
Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
34.5
(17.9 to 54.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-interferon Alfa-2b
Comments It is of interest to test the null hypothesis of 10% plasma b-FGF response rate versus the alternative hypothesis of 30% response rate. Based on the sample size of 30 eligible patients, there will be 84% power to detect this 20% difference in b-FGF response rates. This was based on a two-sided type I error of .05, using the one-sample binomial test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method bionomial proportion test
Comments [Not Specified]
2.Secondary Outcome
Title Non-progression Rate (Clinical Response to Peginterferon Alfa-2b)
Hide Description

Objective tumor response was assessed using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Progression is defined as at least 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing non-target lesions. Stable disease (SD) = did not meet criteria for response or progression.

Non-progression rate = CR + PR + SD.

Time Frame assessed every 9 weeks until suppression of plasma b-FGF level to normal, every 12 weeks until the completion of 12 months of treatment, >= 4 weeks after documented response. After off treatment, every 3 months if <2 years, and every 6 months if 2-3 years
Hide Outcome Measure Data
Hide Analysis Population Description
eligible and treated patients
Arm/Group Title PEG-interferon Alfa-2b
Hide Arm/Group Description:
Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24.1
(10.3 to 43.5)
3.Secondary Outcome
Title Progression Free Survival
Hide Description Progression free survival (PFS) was defined as the time from registration to disease progression, or censored at last known date of non progressive disease.
Time Frame assessed every 9 weeks until suppression of plasma b-FGF level to normal, every 12 weeks until the completion of 12 months of treatment, >= 4 weeks after documented response. After off treatment, every 3 months if <2 years, and every 6 months if 2-3 years
Hide Outcome Measure Data
Hide Analysis Population Description
eligible and treated patients
Arm/Group Title PEG-interferon Alfa-2b
Hide Arm/Group Description:
Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 29
Median (95% Confidence Interval)
Unit of Measure: months
2
(1.8 to 2.3)
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival (OS) time was defined as the time from registration to death from any cause, or censored at last known date of survival.
Time Frame assessed every 3 months if <2 years, and every 6 months if 2-3 years
Hide Outcome Measure Data
Hide Analysis Population Description
eligible and treated
Arm/Group Title PEG-interferon Alfa-2b
Hide Arm/Group Description:
Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 29
Median (95% Confidence Interval)
Unit of Measure: months
9.7
(4.4 to 12.5)
Time Frame Assessed every 3 weeks in induction phase, every 6 weeks in maintenance phase, and for 30 days after the end of treatment, up to 3 years.
Adverse Event Reporting Description Adverse events occurred within 30 days after the end of treatment were reported in the Adverse Event Form for the last cycle. Long term grade 3 or higher adverse event which has not been previously reported were also included in the reporting (assessed every 3 months if patient is <2 years from study entry and every 6 months if 2-3 years).
 
Arm/Group Title PEG-Interferon Alfa-2b
Hide Arm/Group Description Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
PEG-Interferon Alfa-2b
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PEG-Interferon Alfa-2b
Affected / at Risk (%)
Total   13/32 (40.63%) 
Blood and lymphatic system disorders   
Anemia  1  1/32 (3.13%) 
Gastrointestinal disorders   
Constipation  1  1/32 (3.13%) 
Nausea  1  3/32 (9.38%) 
Vomiting  1  1/32 (3.13%) 
Gastrointestinal disorders - Other, spec  1 [1]  1/32 (3.13%) 
General disorders   
Fatigue  1  7/32 (21.88%) 
Chills  1  1/32 (3.13%) 
General disorders and administration sit  1  1/32 (3.13%) 
Pain  1  1/32 (3.13%) 
Infections and infestations   
Infections w/o neutropenia  1  2/32 (6.25%) 
Investigations   
White blood cell decreased  1  1/32 (3.13%) 
Neutrophil count decreased  1  1/32 (3.13%) 
Alanine aminotransferase increased  1  1/32 (3.13%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  1/32 (3.13%) 
Nervous system disorders   
Dizziness  1  1/32 (3.13%) 
Tremor  1  1/32 (3.13%) 
Psychiatric disorders   
Confusion  1  1/32 (3.13%) 
Depression  1  1/32 (3.13%) 
Vascular disorders   
Hypotension  1  1/32 (3.13%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 2.0
[1]
details were unknown (no data)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PEG-Interferon Alfa-2b
Affected / at Risk (%)
Total   31/32 (96.88%) 
Blood and lymphatic system disorders   
Anemia  1  15/32 (46.88%) 
Gastrointestinal disorders   
Constipation  1  4/32 (12.50%) 
Nausea  1  13/32 (40.63%) 
Vomiting  1  5/32 (15.63%) 
Diarrhea  1  4/32 (12.50%) 
General disorders   
Fatigue  1  24/32 (75.00%) 
Fever  1  11/32 (34.38%) 
Chills  1  6/32 (18.75%) 
Injection site reaction  1  8/32 (25.00%) 
General disorders and administration sit  1  2/32 (6.25%) 
Investigations   
White blood cell decreased  1  12/32 (37.50%) 
Neutrophil count decreased  1  12/32 (37.50%) 
Platelet count decreased  1  6/32 (18.75%) 
Weight loss  1  7/32 (21.88%) 
Blood bilirubin increased  1  2/32 (6.25%) 
Alanine aminotransferase increased  1  10/32 (31.25%) 
Creatinine increased  1  4/32 (12.50%) 
Metabolism and nutrition disorders   
Anorexia  1  15/32 (46.88%) 
Dehydration  1  2/32 (6.25%) 
Hypoalbuminemia  1  2/32 (6.25%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  8/32 (25.00%) 
Nervous system disorders   
Dysgeusia  1  2/32 (6.25%) 
Dizziness  1  6/32 (18.75%) 
Nervous system disorders - Other, specif  1 [1]  2/32 (6.25%) 
Tremor  1  2/32 (6.25%) 
Headache  1  5/32 (15.63%) 
Psychiatric disorders   
Insomnia  1  4/32 (12.50%) 
Anxiety  1  6/32 (18.75%) 
Depression  1  5/32 (15.63%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  2/32 (6.25%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  2/32 (6.25%) 
Dry skin  1  2/32 (6.25%) 
Pruritus  1  3/32 (9.38%) 
Rash maculo-papular  1  4/32 (12.50%) 
Skin and subcutaneous tissue disorders -  1  2/32 (6.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 2.0
[1]
details were unknown (no data)
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: Study Statistician
Organization: ECOG Statistical Office
Phone: 617-632-3012
Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00049530     History of Changes
Other Study ID Numbers: CDR0000258114
E2602 ( Other Identifier: Eastern Cooperative Oncology Group )
U10CA021115 ( U.S. NIH Grant/Contract )
First Submitted: November 12, 2002
First Posted: January 27, 2003
Results First Submitted: January 30, 2014
Results First Posted: June 3, 2014
Last Update Posted: October 28, 2015