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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosed18 and overNCI, OtherCDR0000258114
E2602, U10CA021115, ECOG-2602, NCT00049530

Trial Description

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

National Cancer Institute

Ronald S. GoStudy Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00049530
ClinicalTrials.gov processed this data on October 20, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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