Overview

This trial is active, not recruiting.

Condition melanoma (skin)
Treatment peg-interferon alfa-2b
Phase phase 2
Sponsor Eastern Cooperative Oncology Group
Collaborator National Cancer Institute (NCI)
Start date September 2003
End date August 2012
Trial size 32 participants
Trial identifier NCT00049530, CDR0000258114, E2602, U10CA021115

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
peg-interferon alfa-2b
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.

Primary Outcomes

Measure
Plasma b-FGF Level Response
time frame: assessed every 3 weeks until the suppression of plasma b-FGF level to normal, then every 6 weeks until the completion of 12 months of treatment, and upon treatment discontinuation

Secondary Outcomes

Measure
Non-progression Rate (Clinical Response to Peginterferon Alfa-2b)
time frame: assessed every 9 weeks until suppression of plasma b-FGF level to normal, every 12 weeks until the completion of 12 months of treatment, >= 4 weeks after documented response. After off treatment, every 3 months if <2 years, and every 6 months if 2-3 years
Progression Free Survival
time frame: assessed every 9 weeks until suppression of plasma b-FGF level to normal, every 12 weeks until the completion of 12 months of treatment, >= 4 weeks after documented response. After off treatment, every 3 months if <2 years, and every 6 months if 2-3 years
Overall Survival
time frame: assessed every 3 months if <2 years, and every 6 months if 2-3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase II Study of Low Dose Peginterferon Alfa-2b in Patients With Metastatic Melanoma Over-Expressing Basic Fibroblast Growth Factor
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. 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Eastern Cooperative Oncology Group.