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 @ 5:34 PM
Ignite Modification Date:
2025-12-24 @ 5:34 PM
NCT ID:
NCT00003568
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed clearly progressive metastatic or unresectable melanoma
* Must be HLA-A2.1 positive
* Measurable disease
* No active brain metastases, leptomeningeal disease, or seizure disorder
* More than 4 months since prior definitive therapy (surgery or radiotherapy) for brain metastases and must not have evidence of disease on brain CT scan or MRI
* No ascites or pleural effusions
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-1 OR
* Karnofsky 80-100%
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9 g/dL
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No congestive heart failure
* No symptoms of coronary artery disease
* No serious cardiac arrhythmias
* No evidence of prior myocardial infarction on EKG
* Normal cardiac stress test required for all patients over 40 years
Pulmonary:
* FEV\_1 greater than 2.0 liters or at least 75% of predicted
* No chronic obstructive pulmonary disease
Other:
* HIV negative
* No significant systemic infection
* No contraindication to use of pressor agents
* No history of major psychiatric illness
* No other major illness that would significantly increase the risk of immunotherapy
* No other active malignancy except surgically cured nonmelanoma skin cancer or carcinoma in situ or stage I carcinoma of the cervix
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior interleukin-2
* At least 4 weeks since prior vaccine therapy or other cytokine therapy
Chemotherapy:
* One prior chemotherapy regimen allowed
* At least 4 weeks since prior chemotherapy (6 weeks for carmustine or lomustine) and recovered
Endocrine therapy:
* No concurrent steroids
Radiotherapy:
* See Disease Characteristics
* No prior radiotherapy to areas of measurable disease unless there has been clearly progressive disease in this site or there is measurable disease outside of areas of prior radiation
* At least 2 weeks since prior radiotherapy for local control or palliative therapy and recovered
Surgery:
* See Disease Characteristics
* Recovered from prior major surgery
* No prior organ allografts
Other:
* No antihypertensive therapy within 24 hours prior to interleukin-2
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00003568
Study Brief:
Protocol Section:
NCT00003568