Clinical trial · Interventional
Adjuvant Therapy of Skin Melanoma With Alpha Interferon and Naderin
Protocol of Clinical Trial of EAFO 2012: Adjuvant Therapy of Skin Melanoma With Use of Alpha Interferon and Naderin
- 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)
The goal of this clinical trial is to learn if adding alpha interferon to standard treatment works to prevent skin melanoma from coming back after surgery. The study will also learn if different doses of alpha interferon work better than others. The main questions it aims to answer are: * Does alpha interferon help people with melanoma live longer without the cancer returning? * Does a higher dose of alpha interferon work better than a lower dose? * How does alpha interferon affect the immune system? Researchers will compare six different treatment approaches to see which one works best. Participants will: * Have surgery to remove their melanoma * Receive one of six different treatments after surgery: * Radiation therapy (40 Gy) * Low-dose interferon (3 million IU) * Surgery alone (no additional treatment) * High-dose interferon (9 million IU/m² IV) * Low-dose interferon with chemotherapy (dacarbazine + cisplatin) * Chemotherapy alone (dacarbazine + cisplatin) * Have regular check-ups to see if the cancer returns * Have blood tests to check immune system function Key finding: The study will determine which treatment approach provides the best chance of survival without cancer recurrence.
Conditions
Conditions (4)
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 Stage I | Melanoma | CURATED_BROADER | 0.78 |
| Melanoma Stage II | Melanoma | CURATED_BROADER | 0.78 |
| Melanoma Stage III | Melanoma | CURATED_BROADER | 0.78 |
| Skin Melanoma | Cutaneous Melanoma | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant Radiotherapy | Radiation | — | UNRESOLVED |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Dacarbazine (DTIC) | Drug | Dacarbazine | ALIAS |
| Immunological Monitoring | Diagnostic Test | — | UNRESOLVED |
| interferon alfa | Biological | — | UNRESOLVED |
| Skinscope Dermatoscopy | Diagnostic Test | — | UNRESOLVED |
| Surgical resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Surgery + Radiotherapy
- description
- Surgical resection of primary melanoma with wide excision (4-5 cm margin on trunk, 3 cm on head/neck) followed by adjuvant radiotherapy. Radiation: external beam gamma therapy, 2 Gy daily fraction, total dose 40 Gy to primary site, 20 Gy to regional lymph node area. Indicated for localized melanoma (T1-2N0M0) with Clark invasion level I-II. n=49 patients.
- interventionNames
- Procedure: Surgical resection
- Radiation: Adjuvant Radiotherapy
- Diagnostic Test: Immunological Monitoring
- Diagnostic Test: Skinscope Dermatoscopy
- type
- EXPERIMENTAL
- label
- Surgery + Low-Dose IFN-α
- description
- Surgical resection followed by low-dose interferon alfa immunotherapy. Regimen: 3 million IU intradermal daily until cumulative dose 30 million IU, then maintenance therapy (3 million IU single dose) administered only when CD4/CD8 ratio drops below 1.3. Indicated for localized melanoma (T1-4N0M0) with low/intermediate metastasis risk. n=38 patients
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * • Histologically confirmed diagnosis of skin melanoma (stages I-IV according to TNM classification) * Underwent complete surgical resection of primary tumor with negative margins * Age 18 years or older * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Life expectancy of at least 6 months * Adequate bone marrow function: absolute neutrophil count ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L, hemoglobin ≥ 90 g/L * Adequate hepatic function: bilirubin ≤ 1.5 × upper limit of normal (ULN), transaminases ≤ 2.5 × ULN * Adequate renal function: creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min * Willing and able to provide written informed consent * Willing to comply with study procedures and follow-up schedule Exclusion Criteria: * • Presence of distant metastases at the time of diagnosis (except for stage IV patients included per protocol) * Prior immunotherapy, chemotherapy, or radiotherapy for melanoma * History of other malignant neoplasms within the past 5 years (except non-melanoma skin cancer or carcinoma in situ of the cervix) * Severe or uncontrolled organ dysfunction (cardiac, hepatic, renal, pulmonary) * Active infection requiring systemic therapy * Known hypersensitivity to interferon-alpha or any study medications * Known hypersensitivity to dacarbazine, cisplatin, or any excipients * Pregnancy or breastfeeding * Psychiatric or cognitive impairment that would interfere with study participation * Participation in another interventional clinical trial within 30 days prior to enrollment * Any condition that, in the investigator's opinion, would compromise participant safety or interfere with study objectives
References
Publications (0)
Data not yet available