Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT01308294
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed stage II, III or IV melanoma patients.
* Tumor expression of Melan-A.
* Human leukocyte antigen-A2 (HLA-A2) positive.
* Expected survival of at list 3 months.
* Karnofsky scale performance status of 70 % or more.
* Age ≥ 18 years.
* Able to give a written informed consent.
* The following laboratory results:
Hemoglobin ≥ 100g/L, Neutrophil count ≥ 1.5 x 109/L, Lymphocyte count ≥ 0.5 x 109/L, Platelet count ≥ 100 x 109/L, Serum creatinine ≤ 2 mg/dL (0.18mmol/L), Serum bilirubin ≤ 2mg/dL (0.034mmol/L), Granulocyte count \> 2.5x109/L, Aspartate Amino Transférase (ASAT), Alanine Amino Transferase (ALAT) \< 2.5 x upper limit of normal, Activated Partial Thromboplastin Time (aPTT) within the normal ranges ±25%, Thromplastin (TP) ≥ 80%
Exclusion Criteria:
* Clinically significant heart disease.
* Serious illness, eg. serious infections requiring antibiotics, uncontrolled peptic ulcer, or central nervous system disorders.
* History of immunodeficiency disease or autoimmune disease.
* Metastatic disease to the central nervous system, unless treated and stable.
* Known HIV positivity.
* Known seropositivity for hepatitis B surface antigen.
* Concomitant treatment with steroids, antihistamine drugs. Topical or inhalation steroids are permitted.
* Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
* Pregnancy or lactation.
* Women of childbearing potential not using a medically acceptable means of contraception.
* Psychiatric or addictive disorders that may compromise the ability to give informed consent.
* Lack of availability of the patient for immunological and clinical follow-up assessment.
* Coagulation or bleeding disorders.
* Kidney dysfunction with creatinine \> 2 X the upper limit of the normal value.
* Reported strong (allergic) reactions to previous vaccination.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01308294
Study Brief:
Protocol Section:
NCT01308294