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

Phase 2

Completed

Conditions: Melanoma (Skin)

Registration Number: NCT00049530

Lead Sponsor: Eastern Cooperative Oncology Group

Brief Summary: RATIONALE: Peginterferon (PEG-interferon) alfa-2b may stop the growth of cancer by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating patients who have stage IV melanoma.

Detailed Description: OBJECTIVES:

* Determine the ability of low-dose PEG-interferon alfa-2b to suppress plasma basic fibroblast growth factor (b-FGF) levels to normal in patients with metastatic melanoma over-expressing b-FGF.

* Determine the antitumor effect of this drug, in terms of progression-free and overall survival and tumor response, in these patients.

* Correlate tumor activity of this drug with b-FGF and vascular endothelial growth factor levels in the plasma and urine of these patients.

* Determine the safety profile of this drug in these patients.

OUTLINE: This is a multicenter study.

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.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study within 2 years.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Plasma b-FGF Level Response	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	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.

Secondary Outcome Measures

Name	Time	Method
Non-progression Rate (Clinical Response to Peginterferon Alfa-2b)	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	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.
Progression Free Survival	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	Progression free survival (PFS) was defined as the time from registration to disease progression, or censored at last known date of non progressive disease.
Overall Survival	assessed every 3 months if <2 years, and every 6 months if 2-3 years	Overall survival (OS) time was defined as the time from registration to death from any cause, or censored at last known date of survival.

Trial Locations

Locations (32): UAB Comprehensive Cancer Center
🇺🇸
Birmingham, Alabama, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
🇺🇸
Lakeland, Florida, United States
St. Joseph Medical Center
🇺🇸
Bloomington, Illinois, United States
Graham Hospital
🇺🇸
Canton, Illinois, United States
Memorial Hospital
🇺🇸
Carthage, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸
Decatur, Illinois, United States
Eureka Community Hospital
🇺🇸
Eureka, Illinois, United States
Galesburg Clinic, PC
🇺🇸
Galesburg, Illinois, United States
Mason District Hospital
🇺🇸
Havana, Illinois, United States
Hinsdale Hematology Oncology Associates
🇺🇸
Hinsdale, Illinois, United States
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UAB Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States