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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT00003027
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed surgically incurable metastatic malignant melanoma
* Measurable disease
* No active brain metastases or edema
* No leptomeningeal disease
* No ocular melanoma
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9 g/dL
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* SGOT less than 3 times the upper limit of normal unless due to liver metastases
Renal:
* Creatinine less than 1.5 mg/dL OR
* Creatinine clearance at least 75 mL/min
Cardiovascular:
* No congestive heart failure
* No symptoms of coronary artery disease
* No serious cardiac arrhythmias
* No prior myocardial infarction on EKG
* Normal cardiac stress test required for the following:
* Over 50 years of age
* Abnormal EKG
* Prior history of cardiac disease
Pulmonary:
* No symptomatic pulmonary disease
* FEV1 greater than 2.0 L OR at least 75% predicted if over 50 years of age or with history of pulmonary symptoms
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No significant infection
* HIV negative
* No other prior malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No organ allografts
* No significant disease other than malignancy
* No seizure disorder
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior interleukin-2 therapy for metastatic disease
* At least 4 weeks since prior vaccine therapy
* At least 4 weeks since prior adjuvant immunotherapy
Chemotherapy:
* No prior chemotherapy for disease
Endocrine therapy:
* No concurrent corticosteroids
Radiotherapy:
* No prior radiation therapy to measurable disease site unless disease is clearly progressive
* At least 4 weeks since prior radiation therapy for local control or palliation and recovered
Surgery:
* Recovered from prior surgery
Other:
* No prior systemic therapy for metastatic disease
* At least 3 months since definitive therapy for brain metastases
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00003027
Study Brief:
Protocol Section:
NCT00003027