drugset / Trial / NCT07671495

Adjuvant Therapy of Skin Melanoma With Alpha Interferon and Naderin

NCT07671495

Non-randomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2014-01
Primary completion
2017-12
Completion
2018-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 50 mg Intravenous
Subject Dacarbazine Small molecule 1400 mg Intravenous
Subject interferon alfa Protein / enzyme biologic 3 iu Other
Subject interferon alfa Protein / enzyme biologic 9 unknown Other

Indications