Clinical trial · Interventional
Interferon Alfa-2b in Treating Patients With Melanoma and Early Lymph Node Metastasis
A Multicenter Trial of Adjuvant Interferon Alfa-2b for Melanoma Patients With Early Lymph Node Metastasis Detected by Lymphatic Mapping and Sentinel Lymph Node Biopsy
NCT00004196CI-TRIAL-00013506completedPhase 3ClinicalTrials.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: Interferon alfa-2b may interfere with the growth of cancer cells. PURPOSE: Randomized phase III trial to study the effectiveness of interferon alfa-2b in treating patients who have melanoma with early lymph node metastasis.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lymphangiography | Procedure | — | UNRESOLVED |
| Observation | Drug | — | UNRESOLVED |
| recombinant interferon alfa | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- AI
- description
- Patients with metastasis in a single sentinel node with no evidence of extracapsular extension and no metastatic disease in nonsentinel nodes are randomized to 1 of 2 treatment arms. Patients receive adjuvant high-dose interferon alfa-2b IV 5 days a week for 4 weeks, then subcutaneously 3 times a week for 48 weeks
- interventionNames
- Biological: recombinant interferon alfa
- type
- EXPERIMENTAL
- label
- Arm AII
- description
- Patients with metastasis in a single sentinel node with no evidence of extracapsular extension and no metastatic disease in nonsentinel nodes are randomized to 1 of 2 treatment arms. Observational arm: Patients with metastases in more than one sentinel node with evidence of extracapsular extension or metastasis in any nonsentinel node receive adjuvant high-dose interferon alfa-2b as in arm AI.
- interventionNames
- Biological: recombinant interferon alfa
- Drug: Observation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed invasive cutaneous melanoma * Breslow thickness at least 1.0 mm * Primary site must be on head, neck, trunk or extremity * No more than 90 days since biopsy * Protocol A: * One or more sentinel lymph nodes with histologic or immunohistochemical evidence of metastatic melanoma * Prior regional lymph node dissection * Protocol B: * Sentinel lymph nodes with no histologic or immunohistochemical evidence of metastatic melanoma * Sentinel lymph node positive by reverse transcriptase polymerase chain reaction * No prior wide local excision of the primary tumor with a margin greater than 1.5 cm * No primary melanoma involving the eye or mucous membranes * No clinical evidence of satellite lesions or intransit, regional nodal, or distant metastases * No second primary invasive melanoma * No prior surgery in the region of the primary draining nodal basin that would disrupt normal lymphatic drainage patterns (e.g., skin grafts, tissue transfers or flaps, or lymph node dissections) PATIENT CHARACTERISTICS: Age: * 18 to 70 Performance status: * Karnofsky 70-100% Life expectancy: * At least 10 years Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 70,000/mm\^3 * Hemoglobin at least 10.0 g/dL Hepatic: * Bilirubin less than 2.0 mg/dL * SGOT/SGPT less than 3 times upper limit of normal (ULN) * Alkaline phosphatase less than 3 times ULN * No severe decompensated liver disease (e.g., cirrhosis or autoimmune hepatitis) * No other significant liver disease that would preclude study participation Renal: * Creatinine normal Cardiovascular: * No cardiovascular disease (e.g., angina or congestive heart failure) * No myocardial infarction within the past year * No tachyarrhythmias Pulmonary: * No severe debilitating pulmonary disease (e.g., chronic obstructive pulmonary disease) Other: * No hypersensitivity to interferon alfa-2b or related compounds or any component of the injection * No major depression or other major psychiatric illness * No thyroid disorder with thyroid function that is not maintained within the normal range with medications * No autoimmune disease * No primary or secondary immunodeficiencies * No severe diabetes mellitus prone to ketoacidosis * No significant retinal abnormalities * No evidence of infection * No other malignancy within the past 5 years except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I laryngeal cancer * No other medical condition that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after the study PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy Chemotherapy: * No prior chemotherapy Endocrine therapy: * At least 6 months since prior oral or parenteral steroids Radiotherapy: * No prior radiotherapy Surgery: * See Disease Characteristics * No prior organ transplantation Other: * At least 6 months since prior immunosuppressants * No concurrent immunosuppressants resulting from prior organ transplantation
References
Publications (0)
Data not yet available
No reference posted for this study.