PEG-Interferon Alfa-2b in Treating Patients With Stage IV Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00049530
First received: November 12, 2002
Last updated: May 1, 2014
Last verified: May 2014
Results First Received: January 30, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Melanoma (Skin)
Intervention: Biological: PEG-interferon alfa-2b

  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
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
PEG-interferon Alfa-2b 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.

Participant Flow:   Overall Study
    PEG-interferon Alfa-2b  
STARTED     32  
Eligible and Treated     29  
COMPLETED     0  
NOT COMPLETED     32  
Lack of Efficacy                 25  
Adverse Event                 2  
Death                 1  
symptomatic deterioration                 1  
ineligible                 3  



  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.
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).

Reporting Groups
  Description
PEG-Interferon Alfa-2b 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.

Baseline Measures
    PEG-Interferon Alfa-2b  
Number of Participants  
[units: participants]
  29  
Age  
[units: years]
Median ( Full Range )
  64  
  ( 39 to 84 )  
Gender  
[units: participants]
 
Female     9  
Male     20  
Region of Enrollment  
[units: participants]
 
United States     32  



  Outcome Measures
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1.  Primary:   Plasma b-FGF Level 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 ]

2.  Secondary:   Non-progression Rate (Clinical Response to Peginterferon Alfa-2b)   [ 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 ]

3.  Secondary:   Progression Free Survival   [ 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 ]

4.  Secondary:   Overall Survival   [ Time Frame: assessed every 3 months if <2 years, and every 6 months if 2-3 years ]


  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: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012


No publications provided


Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00049530     History of Changes
Other Study ID Numbers: CDR0000258114, E2602, U10CA021115
Study First Received: November 12, 2002
Results First Received: January 30, 2014
Last Updated: May 1, 2014
Health Authority: United States: Federal Government