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

Tracking Information

First Submitted Date ^ICMJE

November 12, 2002

First Posted Date ^ICMJE

January 27, 2003

Results First Submitted Date ^ICMJE

January 30, 2014

Results First Posted Date ^ICMJE

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

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

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 Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

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 ^ICMJE

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

Study Arms ^ICMJE

Experimental: PEG-interferon alfa-2b

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

Original Enrollment ^ICMJE

Not Provided

Actual Study Completion Date ^ICMJE

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 ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

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

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

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

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