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Last Modified: 9/7/2008     First Published: 11/1/2002  
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Phase II Study of Low-Dose PEG-Interferon alfa-2b in Patients With Metastatic Melanoma Over-Expressing Basic Fibroblast Growth Factor

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase
 Type
 Status
 Age
 Sponsor
 Protocol IDs

Phase II
Treatment
Active
18 and over
NCI
ECOG-2602
E2602, NCT00049530

Objectives

  1. 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.
  2. Determine the antitumor effect of this drug, in terms of progression-free and overall survival and tumor response, in these patients.
  3. Correlate tumor activity of this drug with b-FGF and vascular endothelial growth factor levels in the plasma and urine of these patients.
  4. Determine the safety profile of this drug in these patients.

Entry Criteria

Disease Characteristics:

  • Histologically confirmed stage IV melanoma
    • Stage M1a, M1b, or M1c
    • Mucosal, ocular, or unkown 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


  • CNS involvement allowed provided CNS directed therapy has been given and disease has been clinically stable for ≥ 3 months
    • Brain CT scan or MRI to confirm stable disease required ≤ 4 weeks prior to study entry


Prior/Concurrent Therapy:

Biologic therapy

  • At least 4 weeks since prior interferon in the adjuvant or metastatic setting

Chemotherapy

  • At least 4 weeks since prior chemotherapy in the adjuvant or metastatic setting

Endocrine therapy

  • At least 4 weeks since prior endocrine therapy in the adjuvant or metastatic setting

Radiotherapy

  • At least 4 weeks since prior radiotherapy in the adjuvant or metastatic setting

Surgery

  • At least 4 weeks since prior surgery in the adjuvant or metastatic setting

Other

  • At least 4 weeks since other prior therapy in the adjuvant or metastatic setting

Patient Characteristics:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 6 months

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 8 g/dL (transfusions allowed)

Hepatic

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • ALT no greater than 2 times ULN

Renal

  • Creatinine no greater than 1.5 mg/dL

    OR

  • Creatinine clearance at least 60 mL/min

Cardiovascular

  • No myocardial infarction within the past 6 months

Other

  • No 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
  • No other concurrent illness that would preclude study participation
  • No history of severe depression
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

Expected Enrollment

32

A total of 32 patients will be accrued for this study within 2 years.

Outcomes

Primary Outcome(s)

Suppression of plasma basic fibroblast growth factor (b-FGF) level as measured by ELISA every 3-6 weeks

Secondary Outcome(s)

Response rate by CT scan
Overall survival
Progression-free survival
Tumor response by assessing the b-FGF and vascular endothelial growth factor in the plasma and urine
Safety

Outline

This is a multicenter study.

  • Induction: 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 no disease progression, patients then proceed to maintenance.


  • Maintenance: 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.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Ronald Go, MD, Protocol chair
Ph: 608-775-2139; 800-362-9567 ext. 52385

Trial Sites

U.S.A.
Alabama
  Birmingham
 Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
 Clinical Trials Office - Lurleen Wallace Comprehensive Cancer
Ph: 205-934-0309
Florida
  Lakeland
 Lakeland Regional Cancer Center at Lakeland Regional Medical Center
 James Jakub
Ph: 863-904-1900
Illinois
  Aurora
 Rush-Copley Cancer Care Center
 Kendrith Rowland, MD
Ph: 217-383-3010
  Decatur
 Decatur Memorial Hospital Cancer Care Institute
 Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute
Ph: 217-876-6601
  Hinsdale
 Hinsdale Hematology Oncology Associates
 Elyse Schneiderman, MD
Ph: 630-654-1790
  Joliet
 Joliet Oncology-Hematology Associates, Limited - West
 Kendrith Rowland, MD
Ph: 217-383-3010
  Rockford
 Swedish-American Regional Cancer Center
 Clinical Trials Office - Swedish-American Regional Cancer Center
Ph: 815-489-4413
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 Clinical Trials Office - Carle Cancer Center
Ph: 800-446-5532
 CCOP - Carle Cancer Center
 Clinical Trials Office - CCOP - Carle Cancer Center
Ph: 800-446-5532
Indiana
  Michigan City
 Saint Anthony Memorial Health Centers
 Kendrith Rowland, MD
Ph: 217-383-3010
Michigan
  Kalamazoo
 Borgess Medical Center
 Raymond Lord, MD
Ph: 269-373-7488
 Bronson Methodist Hospital
 Raymond Lord, MD
Ph: 269-373-7488
 West Michigan Cancer Center
 Clinical Trials Office - West Michigan Cancer Center
Ph: 269-373-7458
Nebraska
  Omaha
 Alegant Health Cancer Center at Bergan Mercy Medical Center
 Clinical Trials Office - Alegant Health Cancer Center at Bergen Mercy Medical Center
Ph: 402-398-6060
 CCOP - Missouri Valley Cancer Consortium
 Gamini Soori, MD, FACP, FRCP, MBA
Ph: 402-393-3110
 Creighton University Medical Center
 Clinical Trials Office - Creighton University Medical Center
Ph: 402-280-4100
 Immanuel Medical Center
 Gamini Soori, MD, FACP, FRCP, MBA
Ph: 402-393-3110
Ohio
  Akron
 Summa Center for Cancer Care at Akron City Hospital
 Clinical Trials Office - Akron City Hospital
Ph: 330-375-6101
  Canton
 Aultman Cancer Center at Aultman Hospital
 Clinical Trials Office - Aultman Cancer Center at Aultman Hospital
Ph: 330-363-6891
  Cleveland
 MetroHealth Cancer Care Center at MetroHealth Medical Center
 Bruce Averbook, MD, FACS
Ph: 216-778-4795
Pennsylvania
  Bethlehem
 St. Luke's Cancer Network at St. Luke's Hospital
 Sanjiv Agarwala, MD
Ph: 412-648-6507
  Pittsburgh
 UPMC Cancer Centers
 Clinical Trials Office - UPMC Cancer Centers
Ph: 412-647-8073
  Scranton
 Hematology and Oncology Associates of Northeastern Pennsylvania
 Martin Hyzinski, MD
Ph: 570-558-3020
 Mercy Hospital Cancer Center - Scranton
 Martin Hyzinski, MD
Ph: 570-558-3020
South Dakota
  Sioux Falls
 Avera Cancer Institute
 Loren Tschetter, MD
Ph: 605-328-8000
 Medical X-Ray Center, PC
 Loren Tschetter, MD
Ph: 605-328-8000
 Sanford Cancer Center at Sanford USD Medical Center
 Clinical Trials Office - Sanford Cancer Center
Ph: 605-328-1367
West Virginia
  Charleston
 West Virginia University Health Sciences Center - Charleston
 Steven Jubelirer, MD
Ph: 304-388-8380
Wisconsin
  La Crosse
 Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
 Clinical Trials Office - Gundersen Lutheran Cancer Center
Ph: 608-775-2385
 Email: cancerctr@gundluth.org

Registry Information
Official Title Phase II Study of Low Dose Peginterferon Alfa-2b in Patients with Metastatic Melanoma Over-Expressing Basic Fibroblast Growth Factor
Trial Start Date 2003-09-05
Trial Completion Date 2006-04-22 (estimated)
Registered in ClinicalTrials.gov NCT00049530
Date Submitted to PDQ 2002-09-20
Information Last Verified 2008-10-08
NCI Grant/Contract Number CA21115

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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