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PEG-Interferon Alfa-2b in Treating Patients With Stage IV Melanoma - NCT00049530-54601(Clinical Trial 114960)



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City:  La Crosse
State:  
WI
Zip Code: 54601
Conditions: Cutaneous Melanoma
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.
Study summary: 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.
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
Study is available at: Gundersen Lutheran Center for Cancer and Blood
La Crosse, WI 54601
United States

Primary Contact:
Clinical Trials Office - Gundersen Lutheran Cancer Center
Email: cancerctr@gundluth.org
Phone: 608-775-2385
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 21, 2011
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