PEG-Interferon Alfa-2b in Treating Patients With Stage IV Melanoma
Information source: Eastern Cooperative Oncology Group
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Melanoma (Skin)
Intervention: PEG-interferon alfa-2b (Biological)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Eastern Cooperative Oncology Group Official(s) and/or principal investigator(s): Ronald S. Go, MD, Study Chair, Affiliation: Gundersen Lutheran Center for Cancer and Blood
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.
Clinical Details
Official title: Phase II Study of Low Dose Peginterferon Alfa-2b in Patients With Metastatic Melanoma Over-Expressing Basic Fibroblast Growth Factor
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Plasma b-FGF Level Response
Secondary outcome: Non-progression Rate (Clinical Response to Peginterferon Alfa-2b)Progression Free Survival Overall Survival
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
UAB Comprehensive Cancer Center, Birmingham, Alabama 35294, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center, Lakeland, Florida 33805, United States
St. Joseph Medical Center, Bloomington, Illinois 61701, United States
Graham Hospital, Canton, Illinois 61520, United States
Memorial Hospital, Carthage, Illinois 62321, United States
Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois 62526, United States
Eureka Community Hospital, Eureka, Illinois 61530, United States
Galesburg Clinic, PC, Galesburg, Illinois 61401, United States
Mason District Hospital, Havana, Illinois 62644, United States
Hinsdale Hematology Oncology Associates, Hinsdale, Illinois 60521, United States
McDonough District Hospital, Macomb, Illinois 61455, United States
BroMenn Regional Medical Center, Normal, Illinois 61761, United States
Community Cancer Center, Normal, Illinois 61761, United States
Community Hospital of Ottawa, Ottawa, Illinois 61350, United States
Cancer Treatment Center at Pekin Hospital, Pekin, Illinois 61554, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois 61615, United States
Methodist Medical Center of Illinois, Peoria, Illinois 61636, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria, Illinois 61615, United States
OSF St. Francis Medical Center, Peoria, Illinois 61637, United States
Proctor Hospital, Peoria, Illinois 61614, United States
Illinois Valley Community Hospital, Peru, Illinois 61354, United States
Perry Memorial Hospital, Princeton, Illinois 61356, United States
Swedish-American Regional Cancer Center, Rockford, Illinois 61104-2315, United States
Borgess Medical Center, Kalamazoo, Michigan 49001, United States
Bronson Methodist Hospital, Kalamazoo, Michigan 49007, United States
West Michigan Cancer Center, Kalamazoo, Michigan 49007-3731, United States
Summa Center for Cancer Care at Akron City Hospital, Akron, Ohio 44309-2090, United States
Aultman Cancer Center at Aultman Hospital, Canton, Ohio 44710-1799, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio 44109, United States
UPMC Cancer Centers, Pittsburgh, Pennsylvania 15232, United States
West Virginia University Health Sciences Center - Charleston, Charleston, West Virginia 25304, United States
Gundersen Lutheran Center for Cancer and Blood, La Crosse, Wisconsin 54601, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: September 2003
Last updated: May 1, 2014
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