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 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT00317759
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic melanoma
* Stage IV disease
* HLA-A2 or -A3-expressing disease
* Bidimensionally measurable residual disease by palpation or radiographic imaging (e.g., x-ray or CT scan)
* No CNS metastases
* Previously treated CNS involvement allowed provided there is no evidence of CNS disease at least 2 months after completion of therapy
PATIENT CHARACTERISTICS:
Age
* 18 to 75
Performance status
* Karnofsky 80-100%
Life expectancy
* More than 6 months
Hematopoietic
* Platelet count \> 100,000/mm\^3
* Absolute neutrophil count \> 2,000/mm\^3
Hepatic
* SGOT no greater than 3 times upper limit of normal
* Bilirubin no greater than 1.6 mg/dL
* INR no greater than 1.5 times normal
Renal
* Creatinine no greater than 2.0 mg/dL OR
* Creatinine clearance at least 60 mL/min
Cardiovascular
* No congestive heart failure
* No clinically significant hypotension
* No symptoms of coronary artery disease
* No cardiac arrhythmia by EKG requiring drug therapy
Pulmonary
* No clinically significant pulmonary dysfunction
* FEV\_1 at least 1.0 L\*
* DLCO at least 45%\* NOTE: \*For patients with a history of pulmonary dysfunction
Immunologic
* No active infection
* No oral temperature greater than 38.2°C within the past 48 hours
* No systemic infection requiring chronic maintenance or suppressive therapy
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent immunotherapy (e.g., interleukins, interferons, melanoma vaccines, IV immunoglobulins, expanded polyclonal tumor-infiltrating lymphocytes, or lymphokine-activated killer therapy)
Chemotherapy
* At least 3 weeks since prior chemotherapy (standard or experimental)
Endocrine therapy
* No concurrent steroids
Radiotherapy
* At least 3 weeks since prior radiotherapy
Surgery
* Not specified
Other
* At least 3 weeks since prior immunosuppressive therapy
* No concurrent pentoxifylline
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00317759
Study Brief:
Protocol Section:
NCT00317759