CompletedPhase 2

Adjuvant Therapy of Skin Melanoma With Alpha Interferon and Naderin

278 participantsStarted 2014-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 pa…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recurrence-free survival

Timeframe: Up to 5 years following surgical resection

5-year overall survival

Timeframe: 5 years following surgical resection

Change in CD4/CD8 Ratio

Timeframe: Baseline and at 6 months post-treatment

Trial details

NCT IDNCT07671495

SponsorMIPO Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12

View on ClinicalTrials.gov More Melanoma Stage I trials