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Completed
NCT07671495
Adjuvant Therapy of Skin Melanoma With Alpha Interferon and Naderin
Conditions: Melanoma Stage I, Melanoma Stage III, Melanoma Stage II, Skin Melanoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 278
Sponsor: MIPO Clinic
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07671495). StuddyBuddy aggregates publicly available trial information.