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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT00243594
Eligibility Criteria:
Inclusion criteria:
Histologically documented evidence of melanoma
Stage III-IV melanoma according to the 2001 AJCC criteria
Radical lymph node dissection planned, either with curative (stage III) or palliative (stage IV) intent
Melanoma expressing gp100 (compulsory) and tyrosinase (non-compulsory)
HLA-A2.1 phenotype according to lymphocyte HLA typing
ECOG performance status 0-1, life expectancy \> 3 months
Age 18-75 years
Interval since last prior chemotherapy, immunotherapy or radiotherapy at least 4 weeks, no residual toxicity of prior treatment.
WBC \> 3.0 x 109/l, lymphocytes \> 0.8 x 109/l, platelets \> 100 x 109/l, serum creatinine \< 150 μmol/l, serum bilirubin \< 25 μmol/l
Written informed consent
Expected adequacy of follow-up
Exclusion criteria:
No clinical signs of CNS metastases, in patients with a clinical suspicion of other metastases diagnostic tests should be performed to exclude this.
No concomitant use of corticosteroids or other immunosuppressive agents
No history of second malignancy within the last 5 years. Adequately treated basal carcinoma of skin or carcinoma in situ of cervix is acceptable within this period
No serious concomitant disease, no active infections. No autoimmune disease or organ allografts, no clinical suspicion of HIV or Hepatitis B
No contra-indications for MRI-scanning: claustrophobia, pacemaker or pacemaker threads, cerebral clips or artificial heartvalves, internal hearing prosthesis No known allergy to shell fish (contains KLH)
No pregnant or lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00243594
Study Brief:
Protocol Section:
NCT00243594