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 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT00045357
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic melanoma
* HLA type expressing one of the following class II alleles:
* DRB1\*0401
* DRB1\*0404
* DRB1\*1501
* DPB1\*0401
* DPB1\*0402
* Tumor expresses tyrosinase
* Tumor expressing NY-ESO-1 and are HLA type DP4, DP2, or DR7 allowed
* No CNS metastases
* Prior CNS involvement allowed provided there is no evidence of CNS disease at least 2 months after treatment
PATIENT CHARACTERISTICS:
Age
* 18 to 75
Performance status
* Karnofsky 70-100%
Life expectancy
* More than 16 weeks
Hematopoietic
* WBC greater than 4,000/mm\^3
* Absolute neutrophil count greater than 2,000/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hematocrit greater than 30%
Hepatic
* SGOT no greater than 3 times upper limit of normal
* INR no greater than 1.5 due to hepatic dysfunction
* No significant hepatic dysfunction, defined as hepatic toxicity grade 2 or greater
Renal
* Creatinine no greater than 2.0 mg/dL OR
* Creatinine clearance at least 60 mL/min
* Calcium no greater than 12 mg/dL
Cardiovascular
* No significant cardiac abnormalities\*, defined by any 1 of the following:
* Congestive heart failure
* Clinically significant hypotension
* Symptoms of coronary artery disease
* Cardiac arrhythmias present on EKG requiring drug therapy NOTE: \*Patients with a history of cardiovascular disease or any of the above abnormalities undergo a cardiac evaluation, including a cardiac stress test and/or echocardiogram
Pulmonary
* No clinically significant pulmonary dysfunction
* FEV1 at least 1.0 L OR
* FEV1 at least 60%
* DLCO at least 55% (corrected for hemoglobin)
Immunologic
* No acquired or hereditary immunodeficiency
* No autoimmune disease
* No active infection
* No oral temperature greater than 38.2 degrees C within the past 72 hours
* No systemic infection requiring chronic maintenance or suppressive therapy
* HIV negative
Other
* No retinitis or choroiditis
* No history of seizures
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No other concurrent immunotherapy (e.g., interleukins, interferons, melanoma vaccines, IV immunoglobulin, or expanded polyclonal tumor-infiltrating lymphocytes or lymphokine-activated killer therapy)
Chemotherapy
* At least 4 weeks since prior chemotherapy (standard or experimental) and recovered
Endocrine therapy
* No concurrent systemic steroids except for toxicity management
Radiotherapy
* At least 4 weeks since prior radiotherapy
Surgery
* Not specified
Other
* At least 4 weeks since prior immunosuppressive therapy
* More than 4 weeks since prior experimental drugs and recovered
* No concurrent pentoxifylline
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00045357
Study Brief:
Protocol Section:
NCT00045357