At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed stage IV melanoma (M1a, M1b, M1c) or mucosal/ocular/unknown primary
- ✓Plasma basic fibroblast growth factor level ≥15 pg/mL
- ✓Previously untreated or up to 3 prior systemic therapy regimens (excluding vaccine therapy) for metastatic disease
- ✓Measurable or evaluable disease
- ✕Myocardial infarction within the past 6 months
- ✕Other active malignancy within past 5 years (except curatively treated basal cell/squamous cell skin cancer or cervical carcinoma in situ)
- ✕History of severe depression
- ✕Pregnant or nursing
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of Low Dose Peginterferon Alfa-2b in Patients With Metastatic Melanoma Over-Expressing Basic Fibroblast Growth Factor
In Brief
A Phase 2 clinical trial evaluating PEG-interferon alfa-2b for Melanoma (Skin). Completed, enrolled 32 participants across 32 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.