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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-13

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Melanoma (Skin)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PEG-interferon alfa-2b

Intervention Type BIOLOGICAL

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.

Interventions

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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 Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald S. Go, MD

Role: STUDY_CHAIR

Gundersen Lutheran Center for Cancer and Blood

Locations

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UAB Comprehensive Cancer Center

Birmingham, Alabama, United States

Site Status

Lakeland Regional Cancer Center at Lakeland Regional Medical Center

Lakeland, Florida, United States

Site Status

St. Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, United States

Site Status

Eureka Community Hospital

Eureka, Illinois, United States

Site Status

Galesburg Clinic, PC

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, United States

Site Status

McDonough District Hospital

Macomb, Illinois, United States

Site Status

BroMenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center

Normal, Illinois, United States

Site Status

Community Hospital of Ottawa

Ottawa, Illinois, United States

Site Status