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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00049530
First received: November 12, 2002
Last updated: July 12, 2012
Last verified: June 2011

November 12, 2002
July 12, 2012
September 2003
February 2013   (final data collection date for primary outcome measure)
Suppression of plasma basic fibroblast growth factor (b-FGF) level as measured by ELISA every 3-6 weeks [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00049530 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
PEG-Interferon Alfa-2b in Treating Patients With Stage IV Melanoma
Phase II Study of Low Dose Peginterferon Alfa-2b in Patients With Metastatic Melanoma Over-Expressing Basic Fibroblast Growth Factor

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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Melanoma (Skin)
Biological: PEG-interferon alfa-2b
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
32
Not Provided
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00049530
CDR0000258114, ECOG-2602
Not Provided
Robert L. Comis, ECOG Group Chair's Office
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Ronald S. Go, MD Gundersen Lutheran Center for Cancer and Blood
National Cancer Institute (NCI)
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP