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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

Page last updated: August 20, 2015

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