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 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT00003802
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic cutaneous or ocular melanoma that is chemotherapy naive
* Bidimensionally measurable disease
* No pleural effusions or ascites
* No untreated CNS metastases
* Stable brain metastases by CT or MRI scan
* At least 4 weeks since prior steroid therapy
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* WBC at least 4,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2.5 times ULN (unless due to hepatic metastases)
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No active infection
* No known hypersensitivity to E.coli derived proteins
* No other serious medical problems
* No more than 1 primary malignancy within past 5 years, other than:
* Nonmelanomatous skin cancer
* Carcinoma in situ of the cervix
* No history of spinal cord compression
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Prior biologic therapy allowed (e.g., interleukin-2, interferon alfa, or vaccine therapy)
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* See Disease Characteristics
Radiotherapy:
* Prior radiotherapy for primary ocular melanoma, brain metastases, or to metastatic sites encompassing less than 25% of the bone marrow allowed
* No other prior radiotherapy
Surgery:
* At least 2 weeks since prior surgery and recovered
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003802
Study Brief:
Protocol Section:
NCT00003802