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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT00019669
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven metastatic melanoma that has failed standard treatment
* Measurable disease
* HLA-A-201 positive
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Performance status:
* ECOG 0-2
Life expectancy:
* More than 3 months
Hematopoietic:
* WBC ≥ 3,000/mm\^3
* Platelet count ≥ 90,000/mm\^3
* No coagulation disorders
Hepatic:
* Bilirubin ≤ 1.6 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome)
* AST/ALT \< 2 times normal
* Hepatitis B surface antigen negative
Renal:
* Creatinine ≤ 2.0 mg/dL
Cardiovascular:
* No major cardiovascular disease
* No cardiac ischemia by a stress thallium test or other comparable test\*
* No myocardial infarction\*
* No cardiac arrhythmias\* NOTE: \*In order to be eligible to receive interleukin-2 (IL-2)
Pulmonary:
* No major respiratory disease
* No obstructive or restrictive pulmonary disease\* NOTE: \*In order to be eligible to receive IL-2
Immunologic:
* No autoimmune disease
* No known immunodeficiency disease
* No primary or secondary immunodeficiency
* No allergy to eggs
* No active systemic infections
* HIV negative
Other:
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other active major medical illness\* NOTE: \*In order to be eligible to receive IL-2
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior gp100 vaccination
Chemotherapy:
* Not specified
Endocrine therapy:
* No concurrent steroids
Radiotherapy:
* Not specified
Surgery:
* Prior surgery for the malignancy allowed
Other:
* At least 3 weeks since other prior therapy for the malignancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00019669
Study Brief:
Protocol Section:
NCT00019669