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:
NCT00019994
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven metastatic melanoma that has failed standard treatment
* HLA-DRB1\*0401 positive
* Known HLA-A0201 status
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Performance status:
* ECOG 0-2
Life expectancy:
* More than 3 months
Hematopoietic:
* WBC at least 3,000/mm\^3
* Platelet count at least 90,000/mm\^3
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
* AST or ALT less than 3 times normal
* Hepatitis B surface antigen negative
Renal:
* Creatinine no greater than 2.0 mg/dL
Cardiovascular:
* No symptomatic cardiac disease
Immunologic:
* No autoimmune disease
* No primary or secondary immunodeficiency disease
* HIV negative
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active systemic infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior immunization to the entire gp100 molecule
* At least 3 weeks since prior gp100:209-217 antigen peptide
* At least 3 weeks since other prior biologic therapy
Chemotherapy:
* At least 3 weeks since prior chemotherapy
Endocrine therapy:
* At least 3 weeks since prior endocrine therapy
* No concurrent steroid therapy
Radiotherapy:
* At least 3 weeks since prior radiotherapy
Surgery:
* Prior surgery for cancer allowed
Other:
* At least 3 weeks since any prior therapy except surgery for cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00019994
Study Brief:
Protocol Section:
NCT00019994