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PEG-Interferon Alfa-2b in Treating Patients With Stage IV Melanoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), May 2009
First Received: November 12, 2002   Last Updated: May 5, 2009   History of Changes
Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00049530
  Purpose

RATIONALE: 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.


Condition Intervention Phase
Melanoma (Skin)
Biological: PEG-interferon alfa-2b
Phase II

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Interferon alfa-2a Interferon alfa-2b Peginterferon Alfa-2b Interferon alfa-n1 Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of Low Dose Peginterferon Alfa-2b in Patients With Metastatic Melanoma Over-Expressing Basic Fibroblast Growth Factor

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Suppression of plasma basic fibroblast growth factor (b-FGF) level as measured by ELISA every 3-6 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate by CT scan [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Tumor response by assessing the b-FGF and vascular endothelial growth factor in the plasma and urine [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: September 2003
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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.

  • 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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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
  • 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

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/mm^3
  • Platelet count at least 100,000/mm^3
  • 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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049530

  Show 29 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Ronald S. Go, MD Gundersen Lutheran Center for Cancer and Blood
  More Information

Additional Information:
No publications provided

Responsible Party: ECOG Group Chair's Office ( Robert L. Comis )
Study ID Numbers: CDR0000258114, ECOG-2602
Study First Received: November 12, 2002
Last Updated: May 5, 2009
ClinicalTrials.gov Identifier: NCT00049530     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage IV melanoma

Study placed in the following topic categories:
Interferon-alpha
Immunologic Factors
Interferons
Angiogenesis Inhibitors
Antiviral Agents
Recurrence
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Peginterferon alfa-2b
Mitogens
Neuroepithelioma
Nevus
Interferon Alfa-2a
Interferon Alfa-2b

Additional relevant MeSH terms:
Interferon-alpha
Anti-Infective Agents
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Interferons
Angiogenesis Inhibitors
Antiviral Agents
Pharmacologic Actions
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Peginterferon alfa-2b
Nevi and Melanomas
Growth Inhibitors
Angiogenesis Modulating Agents
Interferon Alfa-2a
Interferon Alfa-2b

ClinicalTrials.gov processed this record on May 07, 2009