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

Tracking Information
First Submitted Date ICMJE	November 12, 2002
First Posted Date ICMJE	January 27, 2003
Results First Submitted Date	January 30, 2014
Results First Posted Date	June 3, 2014
Last Update Posted Date	October 28, 2015
Study Start Date ICMJE	September 2003
Actual Primary Completion Date	August 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 1, 2014)	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 ]; 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.
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00049530 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 1, 2014)	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 ]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 [ 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 ]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 [ Time Frame: 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.
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	PEG-Interferon Alfa-2b in Treating Patients With Stage IV Melanoma
Official Title ICMJE	Phase II Study of Low Dose Peginterferon Alfa-2b in Patients With Metastatic Melanoma Over-Expressing Basic Fibroblast Growth Factor
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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Melanoma (Skin)
Intervention ICMJE	Biological: 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.
Study Arms	Experimental: 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.; Intervention: Biological: PEG-interferon alfa-2b
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: November 8, 2006)	32
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	June 2014
Actual Primary Completion Date	August 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion criteria: Histologically confirmed stage IV melanoma Stage M1a, M1b, or M1c Mucosal, ocular, or unknown primary melanoma; Previously untreated OR received up to 3 prior systemic therapy regimens (excluding vaccine therapy) for metastatic disease; Plasma basic fibroblast growth factor level at least 15 pg/mL; Measurable or evaluable disease; Central nervous system (CNS) involvement allowed provided CNS directed therapy has been given and disease has been clinically stable for ≥ 3 months Brain computed tomography (CT) scan or Magnetic resonance imaging (MRI) to confirm stable disease required ≤ 4 weeks prior to study entry; Age: 18 and over; ECOG Performance status of 0-2; Life expectancy at least 6 months; Absolute neutrophil count at least 1,500/mm^3; Platelet count at least 100,000/mm^3; Hemoglobin at least 8 g/dL (transfusions allowed); Bilirubin no greater than 2 times upper limit of normal (ULN); Alanine Aminotransferase (ALT) no greater than 2 times ULN; Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min; At least 4 weeks since prior interferon in the adjuvant or metastatic setting; At least 4 weeks since prior chemotherapy in the adjuvant or metastatic setting; At least 4 weeks since prior endocrine therapy in the adjuvant or metastatic setting; At least 4 weeks since prior radiotherapy in the adjuvant or metastatic setting; At least 4 weeks since prior surgery in the adjuvant or metastatic setting; At least 4 weeks since other prior therapy in the adjuvant or metastatic setting; Negative pregnancy test; Fertile patients must use effective contraception Exclusion criteria: Myocardial infarction within the past 6 months; Other active malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix; Other concurrent illness that would preclude study participation; History of severe depression; Pregnant or nursing
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00049530
Other Study ID Numbers ICMJE	CDR0000258114; E2602 ( Other Identifier: Eastern Cooperative Oncology Group ); U10CA021115 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Eastern Cooperative Oncology Group
Study Sponsor ICMJE	Eastern Cooperative Oncology Group
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Study Chair: Ronald S. Go, MD Gundersen Lutheran Center for Cancer and Blood
PRS Account	Eastern Cooperative Oncology Group
Verification Date	May 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP