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

Melanoma (Skin) Clinical Trial

Official title:

Phase II Study of Low Dose Peginterferon Alfa-2b in Patients With Metastatic Melanoma Over-Expressing Basic Fibroblast Growth Factor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00049530
• Other study ID #: CDR0000258114
• Secondary ID: E2602U10CA021115
• Status: Completed
• Phase: Phase 2
• Start date: January 13, 2004
• Est. completion date: June 2014

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2014
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

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.

Locations

Country	Name	City	State
United States	Summa Center for Cancer Care at Akron City Hospital	Akron	Ohio
United States	UAB Comprehensive Cancer Center	Birmingham	Alabama
United States	St. Joseph Medical Center	Bloomington	Illinois
United States	Aultman Cancer Center at Aultman Hospital	Canton	Ohio
United States	Graham Hospital	Canton	Illinois
United States	Memorial Hospital	Carthage	Illinois
United States	West Virginia University Health Sciences Center - Charleston	Charleston	West Virginia
United States	MetroHealth Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio
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	Borgess Medical Center	Kalamazoo	Michigan
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Gundersen Lutheran Center for Cancer and Blood	La Crosse	Wisconsin
United States	Lakeland Regional Cancer Center at Lakeland Regional Medical Center	Lakeland	Florida
United States	McDonough District Hospital	Macomb	Illinois
United States	BroMenn Regional Medical Center	Normal	Illinois
United States	Community Cancer Center	Normal	Illinois
United States	Community Hospital of Ottawa	Ottawa	Illinois
United States	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Oncology Hematology Associates of Central Illinois, PC - Peoria	Peoria	Illinois
United States	OSF St. Francis Medical Center	Peoria	Illinois
United States	Proctor Hospital	Peoria	Illinois
United States	Illinois Valley Community Hospital	Peru	Illinois
United States	UPMC Cancer Centers	Pittsburgh	Pennsylvania
United States	Perry Memorial Hospital	Princeton	Illinois
United States	Swedish-American Regional Cancer Center	Rockford	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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