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 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT00471133
Eligibility Criteria:
Inclusion Criteria:
* Patients must have documented, histologically confirmed malignant melanoma, American Joint Commission on Cancer (AJCC) Stage IIB- IV. Patients with stage IIb-III disease are only eligible after standard surgical care with wide local excision and appropriate lymph node sampling. Patients with stage IIb, IIc, or III melanoma who are free of disease after surgical resection are also eligible, only if they have refused high dose Interferon-alfa (INTRON A) or have had a recurrence while on Interferon-alfa.
* Patients with choroidal melanoma may participate if they fulfill one of the following criteria: Basal diameter \>16mm; Height \>8mm or involvement of the ciliary body with tumor.
* Patients must be at least 18 years of age and must be capable of understanding the consent form and giving informed consent.
* Karnofsky Score \> 80
* Life Expectancy \> 6 months
* HLA-A1, A2, A24, or B35+ as assessed by low resolution phenotyping
* White blood cell count ≥ 2,000/mm3
* Platelet count ≥ 100,000/mm3
* Neutrophil count ≥ 1,000/mm3
* Hemoglobin ≥ 9.0 g/dL
* Serum AST and ALT ≤ 2.5 times upper limit of normal (ULN)
* Serum Bilirubin ≤ 2.0 mg/dL
* Serum Creatinine ≤ 2.0 mg/dL
* Serum Alkaline Phosphatase \< 2.5 times ULN
* Serum Creatine phosphokinase (CPK) \< 2.5 times ULN
Exclusion Criteria:
* Documented metastases in brain
* Clinical history of HIV, HepB, HepC, and/or HTLV I.
* Active autoimmune disease other than vitiligo
* Patients previously immunized using the tyrosinase DNA sequence, protein, or peptides.
* Systemic immunosuppressive therapy (corticosteroids, or other immunosuppressive drugs) within the previous 28 days
* Surgery and/or radiotherapy within the previous 28 days
* Chemotherapy and/or biotherapy within the previous 28 days
* Participation in an investigational study within previous 28 days
* Patients with cardiac demand pacemakers.
* Women who are pregnant or \< 3 months post partum or nursing.
* Women of child-bearing potential and sexually active men must be using appropriate contraception during the course of this study.
* Any other concurrent medical condition that in the opinion of the Principal Investigator or co-Principal Investigator's would preclude study compliance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00471133
Study Brief:
Protocol Section:
NCT00471133