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 @ 10:59 PM
Ignite Modification Date:
2025-12-24 @ 10:59 PM
NCT ID:
NCT00002669
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed melanoma that is metastatic and unresectable
* Measurable, progressive disease (by physical exam and/or noninvasive imaging)
* No prior irradiation of indicator lesions
* No CNS metastases (confirmed by CT or MRI)
PATIENT CHARACTERISTICS:
Age:
* 18 to 70
Performance status:
* Karnofsky 60-100%
Life expectancy:
* Greater than 3 months
Hematopoietic:
* WBC at least 2,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* No serious hepatic disease
Renal:
* Creatinine no greater than 1.65 mg/dL
* No serious renal disease
Cardiovascular:
* No serious cardiac disease
Pulmonary:
* No serious pulmonary disease
Other:
* No organ allograft
* No autoimmune disease
* No uncontrolled infection
* No active peptic ulcer
* No hyper or hypothyroidism
* No requirement for corticosteroids
* No second malignancy except basal cell skin carcinoma or carcinoma in situ of the cervix
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior immunotherapy with interleukin-2
* No prior interferon alfa in combination with cisplatin or dacarbazine
Chemotherapy:
* No prior chemotherapy with cisplatin in combination with dacarbazine
* More than 3 months since prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* Prior radiotherapy allowed
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00002669
Study Brief:
Protocol Section:
NCT00002669