Adjuvant Therapy of Skin Melanoma With Alpha Interferon and Naderin (ATSMAIN)

Protocol of Clinical Trial of EAFO 2012: Adjuvant Therapy of Skin Melanoma With Use of Alpha Interferon and Naderin

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.

Study Overview

• Status: Completed
• Conditions: Melanoma Stage III; Skin Melanoma; Melanoma Stage I; Melanoma Stage II
• Intervention / Treatment: Procedure: Surgical resection; Radiation: Adjuvant Radiotherapy; Diagnostic test: Immunological Monitoring; Diagnostic test: Skinscope Dermatoscopy; Biological: interferon alfa; Drug: Dacarbazine (DTIC); Drug: Cisplatin

Detailed Description

Study Rationale Cutaneous melanoma has a clinically meaningful risk of recurrence after complete surgical resection, particularly in higher-risk disease. Interferon alfa has historically been investigated as adjuvant immunotherapy in melanoma; randomized trials and meta-analyses have shown modest improvements in relapse-related endpoints with clinically important toxicity, and no consistent evidence that higher-dose strategies provide greater benefit than lower-dose strategies.

This study compared multiple adjuvant approaches used in local practice, including differing interferon dose intensities and combinations with cytotoxic chemotherapy or radiotherapy, to explore their comparative associations with recurrence and survival outcomes.

Study Design and Setting This was a single-country, comparative interventional study conducted after definitive surgery for cutaneous melanoma. Participants were allocated to one of six post-operative management groups based on clinical factors and treatment availability (non-randomized, open-label assignment).

Interventions (post-operative groups)

After surgical resection, participants received one of the following:

Adjuvant radiotherapy to the surgical bed: total dose 40 Gy.

Low-dose interferon alfa: 3 million IU subcutaneously on a scheduled regimen.

Observation / surgery alone (no adjuvant therapy).

Higher-dose interferon alfa: 9 million IU/m² intravenously on a scheduled regimen.

Low-dose interferon alfa + polychemotherapy: dacarbazine + cisplatin.

Polychemotherapy alone: dacarbazine + cisplatin. (Administration schedules, cycle lengths, and duration should be specified in the protocol or an accessible supporting document, consistent with protocol reporting standards.)

Assessments and Follow-up

Participants underwent baseline clinical evaluation after surgery and were followed at prespecified intervals for:

Disease status/recurrence surveillance (clinical assessments and imaging per local standard schedule).

Safety monitoring including treatment-emergent adverse events.

Immune monitoring via peripheral blood sampling with lymphocyte subset evaluation (including CD4/CD8 ratio) at baseline and predefined follow-up timepoints.

Outcomes (high-level; avoid duplicating Outcome Measures section) The study evaluated time-to-event and proportion-based clinical outcomes (recurrence and survival endpoints), safety/tolerability of each adjuvant approach, and longitudinal changes in immune markers.

Statistical Considerations (high-level) Time-to-event outcomes were planned for analysis using Kaplan-Meier methods with between-group comparisons using log-rank testing. Immune marker changes were planned for within- and between-group comparisons using parametric or nonparametric methods depending on distributional assumptions. A two-sided significance threshold of p < 0.05 was prespecified.

Limitations (protocol-relevant, non-results) Because treatment assignment was non-randomized, comparative estimates between groups are vulnerable to confounding by indication and selection bias. Interpretation of between-group differences therefore requires caution and may require adjustment methods (e.g., multivariable models/propensity approaches) if covariates were collected and sample size permits.

• Study Type: Interventional
• Enrollment (Actual): 278
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgery + Radiotherapy; 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.	Procedure: Surgical resection; Wide excision of primary skin melanoma under general intravenous anesthesia. Incision margin: 4-5 cm from visible tumor edge on trunk, 3 cm on head and neck, excised as a single block with subcutaneous fat and superficial fascia. For lower extremity melanoma in 7 patients, wide excision performed without skin closure (open wound management). Regional lymphadenectomy (Duke's operation for inguinal area or axillary lymphadenectomy) performed if enlarged regional lymph nodes present or for Clark invasion level III-IV; Other Names: Wide excision; melanoma surgery; Radiation: Adjuvant Radiotherapy; External beam gamma radiotherapy delivered to primary melanoma site and regional lymph node area. Regimen: 2 Gray (Gy) per fraction daily. Total dose: 40 Gy to primary tumor site, 20 Gy to regional lymph node area. Indicated only for localized melanoma with Clark invasion level I-II (T1-2N0M0). Not recommended for deeper invasion (T3-4N0M0) as it may accelerate disease progression; Other Names: External beam radiotherapy; gamma therapy; Diagnostic test: Immunological Monitoring; Monitoring of cellular immunity parameters including CD3, CD4, CD8, and CD4/CD8 ratio (immune regulatory index) using monoclonal antibodies. Performed at baseline pre-surgery, then at 1 month post-surgery, every 2 months for first year, and every 3 months for subsequent 5 years. CD4/CD8 ratio <1.3 indicates immunosuppression requiring intervention. Ratio decline over 3-6 months predicts disease recurrence in 98.2% of cases.; Other Names: CD4/CD8 ratio; immune regulatory index; flow cytometry; Diagnostic test: Skinscope Dermatoscopy; Non-invasive dermatoscopy device (Menard, Japan) for detecting subclinical intradermal satellite metastases in melanoma patients. Provides 40-80x magnification with surface and deep imaging modes. Enables photo/video capture and analysis. Sensitivity: 75.0±4.1% for detecting intradermal metastases vs. 26.0±3.4% with visual examination alone. Helps determine appropriate surgical margins. Priority certificate No.2009/1105.1 dated 04.09.2009.; Other Names: Menard Skinscope; video dermatoscopy
Experimental: Surgery + Low-Dose IFN-α; 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	Procedure: Surgical resection; Wide excision of primary skin melanoma under general intravenous anesthesia. Incision margin: 4-5 cm from visible tumor edge on trunk, 3 cm on head and neck, excised as a single block with subcutaneous fat and superficial fascia. For lower extremity melanoma in 7 patients, wide excision performed without skin closure (open wound management). Regional lymphadenectomy (Duke's operation for inguinal area or axillary lymphadenectomy) performed if enlarged regional lymph nodes present or for Clark invasion level III-IV; Other Names: Wide excision; melanoma surgery; Diagnostic test: Immunological Monitoring; Monitoring of cellular immunity parameters including CD3, CD4, CD8, and CD4/CD8 ratio (immune regulatory index) using monoclonal antibodies. Performed at baseline pre-surgery, then at 1 month post-surgery, every 2 months for first year, and every 3 months for subsequent 5 years. CD4/CD8 ratio <1.3 indicates immunosuppression requiring intervention. Ratio decline over 3-6 months predicts disease recurrence in 98.2% of cases.; Other Names: CD4/CD8 ratio; immune regulatory index; flow cytometry; Diagnostic test: Skinscope Dermatoscopy; Non-invasive dermatoscopy device (Menard, Japan) for detecting subclinical intradermal satellite metastases in melanoma patients. Provides 40-80x magnification with surface and deep imaging modes. Enables photo/video capture and analysis. Sensitivity: 75.0±4.1% for detecting intradermal metastases vs. 26.0±3.4% with visual examination alone. Helps determine appropriate surgical margins. Priority certificate No.2009/1105.1 dated 04.09.2009.; Other Names: Menard Skinscope; video dermatoscopy; Biological: interferon alfa; Recombinant interferon alfa (IFN-α) immunotherapy administered in two dosing regimens. Low-dose regimen: 3 million IU intradermal daily until cumulative 30 million IU, then maintenance 3 million IU single dose only when CD4/CD8 ratio <1.3. High-dose regimen: 9 million IU/m² intravenous every 2 days for 4 total doses. High-dose regimen associated with severe adverse events (fever 39-40°C, headache, nausea, cardiotoxicity, hepatotoxicity, nephrotoxicity, leukopenia) leading to treatment discontinuation in 29.6% of patients.; Other Names: IFN-α; recombinant interferon alpha
Active Comparator: Surgery Alone (Control); Surgical resection only, no adjuvant therapy. Wide excision of primary melanoma with margins 4-5 cm on trunk, 3 cm on head/neck. Regional lymphadenectomy performed if enlarged nodes present. Indicated for localized melanoma (T1-4N0M0) with low/intermediate metastasis risk as control group. n=64 patients.	Procedure: Surgical resection; Wide excision of primary skin melanoma under general intravenous anesthesia. Incision margin: 4-5 cm from visible tumor edge on trunk, 3 cm on head and neck, excised as a single block with subcutaneous fat and superficial fascia. For lower extremity melanoma in 7 patients, wide excision performed without skin closure (open wound management). Regional lymphadenectomy (Duke's operation for inguinal area or axillary lymphadenectomy) performed if enlarged regional lymph nodes present or for Clark invasion level III-IV; Other Names: Wide excision; melanoma surgery; Diagnostic test: Immunological Monitoring; Monitoring of cellular immunity parameters including CD3, CD4, CD8, and CD4/CD8 ratio (immune regulatory index) using monoclonal antibodies. Performed at baseline pre-surgery, then at 1 month post-surgery, every 2 months for first year, and every 3 months for subsequent 5 years. CD4/CD8 ratio <1.3 indicates immunosuppression requiring intervention. Ratio decline over 3-6 months predicts disease recurrence in 98.2% of cases.; Other Names: CD4/CD8 ratio; immune regulatory index; flow cytometry; Diagnostic test: Skinscope Dermatoscopy; Non-invasive dermatoscopy device (Menard, Japan) for detecting subclinical intradermal satellite metastases in melanoma patients. Provides 40-80x magnification with surface and deep imaging modes. Enables photo/video capture and analysis. Sensitivity: 75.0±4.1% for detecting intradermal metastases vs. 26.0±3.4% with visual examination alone. Helps determine appropriate surgical margins. Priority certificate No.2009/1105.1 dated 04.09.2009.; Other Names: Menard Skinscope; video dermatoscopy
Experimental: Surgery + High-Dose IFN-α; Surgical resection followed by high-dose interferon alfa immunotherapy. Regimen: 9 million IU/m² intravenous every 2 days for a total of 4 doses. Indicated for locoregional melanoma (T3-4N0-1M0) with intermediate/high metastasis risk. Treatment discontinued in 29.6% of patients due to severe adverse events (hepatotoxicity, nephrotoxicity, cardiotoxicity, flu-like syndrome, leukopenia). n=37 patients.	Procedure: Surgical resection; Wide excision of primary skin melanoma under general intravenous anesthesia. Incision margin: 4-5 cm from visible tumor edge on trunk, 3 cm on head and neck, excised as a single block with subcutaneous fat and superficial fascia. For lower extremity melanoma in 7 patients, wide excision performed without skin closure (open wound management). Regional lymphadenectomy (Duke's operation for inguinal area or axillary lymphadenectomy) performed if enlarged regional lymph nodes present or for Clark invasion level III-IV; Other Names: Wide excision; melanoma surgery; Diagnostic test: Immunological Monitoring; Monitoring of cellular immunity parameters including CD3, CD4, CD8, and CD4/CD8 ratio (immune regulatory index) using monoclonal antibodies. Performed at baseline pre-surgery, then at 1 month post-surgery, every 2 months for first year, and every 3 months for subsequent 5 years. CD4/CD8 ratio <1.3 indicates immunosuppression requiring intervention. Ratio decline over 3-6 months predicts disease recurrence in 98.2% of cases.; Other Names: CD4/CD8 ratio; immune regulatory index; flow cytometry; Diagnostic test: Skinscope Dermatoscopy; Non-invasive dermatoscopy device (Menard, Japan) for detecting subclinical intradermal satellite metastases in melanoma patients. Provides 40-80x magnification with surface and deep imaging modes. Enables photo/video capture and analysis. Sensitivity: 75.0±4.1% for detecting intradermal metastases vs. 26.0±3.4% with visual examination alone. Helps determine appropriate surgical margins. Priority certificate No.2009/1105.1 dated 04.09.2009.; Other Names: Menard Skinscope; video dermatoscopy; Biological: interferon alfa; Recombinant interferon alfa (IFN-α) immunotherapy administered in two dosing regimens. Low-dose regimen: 3 million IU intradermal daily until cumulative 30 million IU, then maintenance 3 million IU single dose only when CD4/CD8 ratio <1.3. High-dose regimen: 9 million IU/m² intravenous every 2 days for 4 total doses. High-dose regimen associated with severe adverse events (fever 39-40°C, headache, nausea, cardiotoxicity, hepatotoxicity, nephrotoxicity, leukopenia) leading to treatment discontinuation in 29.6% of patients.; Other Names: IFN-α; recombinant interferon alpha
Experimental: Surgery + Low-Dose IFN-α + Polychemotherapy; Surgical resection followed by sequential immunochemotherapy. Phase 1: Low-dose interferon alfa 3 million IU intradermal daily to cumulative 30 million IU. Phase 2: 6 cycles of polychemotherapy (every 21 days): dacarbazine 1400 mg IV + cisplatin 50 mg IV. Indicated for locoregional melanoma (T3-4N0-1M0) with intermediate/high metastasis risk. n=47 patients.	Procedure: Surgical resection; Wide excision of primary skin melanoma under general intravenous anesthesia. Incision margin: 4-5 cm from visible tumor edge on trunk, 3 cm on head and neck, excised as a single block with subcutaneous fat and superficial fascia. For lower extremity melanoma in 7 patients, wide excision performed without skin closure (open wound management). Regional lymphadenectomy (Duke's operation for inguinal area or axillary lymphadenectomy) performed if enlarged regional lymph nodes present or for Clark invasion level III-IV; Other Names: Wide excision; melanoma surgery; Diagnostic test: Immunological Monitoring; Monitoring of cellular immunity parameters including CD3, CD4, CD8, and CD4/CD8 ratio (immune regulatory index) using monoclonal antibodies. Performed at baseline pre-surgery, then at 1 month post-surgery, every 2 months for first year, and every 3 months for subsequent 5 years. CD4/CD8 ratio <1.3 indicates immunosuppression requiring intervention. Ratio decline over 3-6 months predicts disease recurrence in 98.2% of cases.; Other Names: CD4/CD8 ratio; immune regulatory index; flow cytometry; Diagnostic test: Skinscope Dermatoscopy; Non-invasive dermatoscopy device (Menard, Japan) for detecting subclinical intradermal satellite metastases in melanoma patients. Provides 40-80x magnification with surface and deep imaging modes. Enables photo/video capture and analysis. Sensitivity: 75.0±4.1% for detecting intradermal metastases vs. 26.0±3.4% with visual examination alone. Helps determine appropriate surgical margins. Priority certificate No.2009/1105.1 dated 04.09.2009.; Other Names: Menard Skinscope; video dermatoscopy; Biological: interferon alfa; Recombinant interferon alfa (IFN-α) immunotherapy administered in two dosing regimens. Low-dose regimen: 3 million IU intradermal daily until cumulative 30 million IU, then maintenance 3 million IU single dose only when CD4/CD8 ratio <1.3. High-dose regimen: 9 million IU/m² intravenous every 2 days for 4 total doses. High-dose regimen associated with severe adverse events (fever 39-40°C, headache, nausea, cardiotoxicity, hepatotoxicity, nephrotoxicity, leukopenia) leading to treatment discontinuation in 29.6% of patients.; Other Names: IFN-α; recombinant interferon alpha; Drug: Dacarbazine (DTIC); Alkylating agent chemotherapy. Administered intravenously at 1400 mg per cycle. Used in combination with cisplatin for adjuvant polychemotherapy. Cycle repeats every 21 days for total of 6 cycles. Common adverse effects: nausea, vomiting, stomatitis, alopecia, short-term diarrhea.; Other Names: DTIC; imidazole carboxamide; Drug: Cisplatin; Platinum-based chemotherapy agent. Administered intravenously at 50 mg per cycle. Used in combination with dacarbazine for adjuvant polychemotherapy. Cycle repeats every 21 days for total of 6 cycles. Adverse effects: nausea, vomiting, nephrotoxicity (managed with hydration), ototoxicity; Other Names: CDDP; platinol
Active Comparator: Surgery + Polychemotherapy Alone (Control); Surgical resection followed by adjuvant polychemotherapy alone (control group for locoregional melanoma). Regimen: 6 cycles every 21 days of dacarbazine 1400 mg IV + cisplatin 50 mg IV. Indicated for locoregional melanoma (T3-4N0-1M0) with intermediate/high metastasis risk. n=43 patients.	Procedure: Surgical resection; Wide excision of primary skin melanoma under general intravenous anesthesia. Incision margin: 4-5 cm from visible tumor edge on trunk, 3 cm on head and neck, excised as a single block with subcutaneous fat and superficial fascia. For lower extremity melanoma in 7 patients, wide excision performed without skin closure (open wound management). Regional lymphadenectomy (Duke's operation for inguinal area or axillary lymphadenectomy) performed if enlarged regional lymph nodes present or for Clark invasion level III-IV; Other Names: Wide excision; melanoma surgery; Diagnostic test: Immunological Monitoring; Monitoring of cellular immunity parameters including CD3, CD4, CD8, and CD4/CD8 ratio (immune regulatory index) using monoclonal antibodies. Performed at baseline pre-surgery, then at 1 month post-surgery, every 2 months for first year, and every 3 months for subsequent 5 years. CD4/CD8 ratio <1.3 indicates immunosuppression requiring intervention. Ratio decline over 3-6 months predicts disease recurrence in 98.2% of cases.; Other Names: CD4/CD8 ratio; immune regulatory index; flow cytometry; Diagnostic test: Skinscope Dermatoscopy; Non-invasive dermatoscopy device (Menard, Japan) for detecting subclinical intradermal satellite metastases in melanoma patients. Provides 40-80x magnification with surface and deep imaging modes. Enables photo/video capture and analysis. Sensitivity: 75.0±4.1% for detecting intradermal metastases vs. 26.0±3.4% with visual examination alone. Helps determine appropriate surgical margins. Priority certificate No.2009/1105.1 dated 04.09.2009.; Other Names: Menard Skinscope; video dermatoscopy; Drug: Dacarbazine (DTIC); Alkylating agent chemotherapy. Administered intravenously at 1400 mg per cycle. Used in combination with cisplatin for adjuvant polychemotherapy. Cycle repeats every 21 days for total of 6 cycles. Common adverse effects: nausea, vomiting, stomatitis, alopecia, short-term diarrhea.; Other Names: DTIC; imidazole carboxamide; Drug: Cisplatin; Platinum-based chemotherapy agent. Administered intravenously at 50 mg per cycle. Used in combination with dacarbazine for adjuvant polychemotherapy. Cycle repeats every 21 days for total of 6 cycles. Adverse effects: nausea, vomiting, nephrotoxicity (managed with hydration), ototoxicity; Other Names: CDDP; platinol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence-free survival	Time from surgical resection to first documented recurrence of melanoma (local, regional, or distant) or death from any cause, whichever occurs first. Assessed through clinical examination, imaging studies, and histopathological confirmation when applicable.	Up to 5 years following surgical resection
5-year overall survival	Proportion of participants alive at 5 years following surgical resection. Survival status assessed through clinical follow-up visits and medical records review.	5 years following surgical resection
Change in CD4/CD8 Ratio	Change in the ratio of CD4-positive to CD8-positive T lymphocytes from baseline to post-treatment. Measured by flow cytometry using peripheral blood samples. Assesses immunologic response to interferon-alpha therapy.	Baseline and at 6 months post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-related adverse events	Proportion of participants experiencing treatment-related adverse events, including severity grading according to Common Terminology Criteria for Adverse Events (CTCAE). Particular focus on toxicity leading to treatment discontinuation.	Through treatment completion, up to 12 months
Time to recurrence	Time from surgical resection to first documented recurrence of melanoma, measured in months. Participants without recurrence are censored at the date of last follow-up.	Up to 5 years following surgical resection
Disease-free survival	Time from surgical resection to first recurrence, second primary melanoma, or death from any cause, whichever occurs first.	Up to 5 years following surgical resection

Collaborators and Investigators

• Sponsor: MIPO Clinic
• Collaborators: Asfendiyarov Kazakh National Medical University; Kazakh Research Institute of Oncology & Radiology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Immunotherapy; Melanoma; Overall Survival; Adjuvant Therapy; Alpha Interferon; Recurrence-Free Survival; CD4/CD8 Ratio
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Melanoma; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Investigative Techniques; Therapeutics; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Azoles; Cell Count; Cytological Techniques; Hematologic Tests; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Leukocyte Count; Biological Factors; Triazenes; Imidazoles; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Chemistry Techniques, Analytical; Intercellular Signaling Peptides and Proteins; Platinum Compounds; Radiotherapy; Cell Separation; Immunologic Techniques; Cytokines; Combined Modality Therapy; Interferon Type I; Interferons; Blood Cell Count; Photometry; Immunologic Tests; Monitoring, Physiologic; Immune System Phenomena; Fluorometry; Luminescent Measurements; Lymphocyte Count; Cytophotometry; CD4 Lymphocyte Count; Dacarbazine; Cisplatin; Interferon-alpha; Radiotherapy, Adjuvant; Flow Cytometry; Monitoring, Immunologic; CD4-CD8 Ratio
• Other Study ID Numbers: 5; EAFO Protocol 2012 (Other Identifier: EAFO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No