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 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT00031733
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of stage IIB, IIC, III, or IV cutaneous melanoma OR stage III or IV ocular or mucosal melanoma
* Resected or rendered disease-free
* HLA-A2.1-positive by standard cytotoxicity assay
* Tumor tissue must be available for analysis of gp100 staining and tyrosinase and MART-1 expression by immunohistochemistry
* Must be positive for at least 1 antigen
* Failed, ineligible for, or refused prior interferon alfa
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-1
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,000/mm\^3
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9.0 g/dL
* No bleeding disorder
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
* SGOT/SGPT no greater than 2.5 times normal
* No coagulation disorder
* Hepatitis surface antigen B negative
* Hepatitis C negative
Renal:
* Creatinine no greater than 2.0 mg/dL
Cardiovascular:
* No major cardiovascular illness
Pulmonary:
* No major respiratory illness
Immunologic:
* No prior uveitis
* No prior autoimmune inflammatory eye disease
* No immune hemolytic anemia
* No other active autoimmune disease
Other:
* HIV negative
* No major gastrointestinal illness
* No other malignancy within the past 5 years except squamous cell skin cancer or carcinoma in situ of the cervix curatively treated at least 30 days ago
* No major systemic infection (e.g., pneumonia or sepsis)
* No other major medical illness
* No prior allergic reaction to Montanide ISA-51 or alum adjuvant
* No requirement for steroid therapy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
* No prior tyrosinase:368-376 (370D), gp100:209-217 (210M), or MART-1:26-35 (27L) peptides
Chemotherapy:
* At least 1 month since prior adjuvant chemotherapy for this disease
* No concurrent adjuvant chemotherapy
Endocrine therapy:
* No concurrent steroids
Radiotherapy:
* At least 1 month since prior radiotherapy for this disease
* No concurrent radiotherapy
Surgery:
* See Disease Characteristics
Other:
* At least 1 month since other prior therapy, including adjuvant therapy, for this disease
* No other concurrent therapy, including adjuvant therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00031733
Study Brief:
Protocol Section:
NCT00031733