Clinical trial · Interventional
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
NCT00049530CI-TRIAL-00067696completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEG-interferon alfa-2b | Biological | Peginterferon Alfa-2b | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PEG-interferon alfa-2b
- description
- 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.
- interventionNames
- Biological: PEG-interferon alfa-2b
Primary outcomes (1)
- measure
- Plasma b-FGF Level Response
- timeFrame
- 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
- description
- The primary endpoint was the suppression of plasma b-FGF level with low dose peginterferon alfa-2b. A clinically important reduction of plasma b-FGF levels was determined to be a level less than or equal to 7.5 pg/mL. A patient was considered to have a suppressed plasma b-FGF level, if the patient experienced the clinically significant reduction (less than or equal to 7.5 pg/mL) of plasma b-FGF levels for two consecutive determinations which were at least three weeks apart. This was considered as a b-FGF response.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.