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:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-24 @ 1:30 PM
NCT ID:
NCT00003895
Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically confirmed primary melanoma of Breslow thickness 1.0-4.0 mm; patients who have had only their initial biopsy are preferred; however, those who have already undergone a wide local excision are also eligible; patients may be enrolled up to three months after their wide local excision
* Patients whose melanoma is \> 4.0 mm thick who have positive or negative regional lymph nodes are also eligible
* After accrual to the original 26 patient goal, all patients must be enrolled prior to sentinel lymph node dissection; patients with previous lymph node dissection will not be eligible
* Patients must be HLA typed and be shown to be HLA-A2.1+ by either serologic techniques, flow cytometry, or molecular techniques
* Patients must be ambulatory with good performance status (Karnofsky performance status \[PS\] 80-100)
* White blood cell (WBC) \>= 3500/mm\^3
* Platelets (Plt) \>= 100,000/mm\^3
* Hemoglobin \>= 9 gm/100 ml
* Serum creatinine =\< 2 mg/dl
* Total bilirubin =\< 2.0 mg/dl
* Patients must have recovered from any effects of major surgery and be free of significant systemic infection
* Patients must be negative for human immunodeficiency virus (HIV) antibody by enzyme-linked immunosorbent assay (ELISA) (or negative by Western blot if ELISA is positive) if they are considered to be at high risk; others do not require serologic testing if there are no symptoms or risk factors for HIV disease
* Women of childbearing potential must have a negative pregnancy test and should avoid becoming pregnant while on treatment
* Patients must give written informed consent prior to initiation of therapy; patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy
Exclusion Criteria:
* Patients must not have clinically detectable distant metastases
* Patients who require or are likely to require systemic corticosteroids for intercurrent illness
* Patients with any significant medical disease other than the malignancy (e.g. chronic obstructive pulmonary disorder \[COPD\], patients with ascites or pleural effusions) which in the opinion of the investigator would significantly increase the risk of immunotherapy
* Patient should be free of any other cancers or deemed at low risk for their recurrence
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
17 Years
Study:
NCT00003895
Study Brief:
Protocol Section:
NCT00003895