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 @ 11:58 AM
Ignite Modification Date:
2025-12-24 @ 11:58 AM
NCT ID:
NCT00005961
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven unresectable locally recurrent or metastatic melanoma
* Chemotherapy naive with no more than 2 prior immunotherapy regimens (including cytokines, vaccines, or adjuvant interferon) OR
* Prior chemotherapy failure with no more than 2 prior immunotherapy regimens (including adjuvant interferon) and no more than 1 prior chemotherapy regimen (which may include carmustine) not including antiangiogenesis therapy
* Measurable disease
* At least 20 mm in at least 1 dimension by conventional technique OR at least 10 mm in at least 1 dimension by spiral CT scan
* No disease confined only to the CNS
* No uncontrolled symptomatic brain metastases regardless of other disease sites
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,200/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* AST and/or ALT no greater than 3 times upper limit of normal
* PT normal
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance greater than 60 mL/min
Pulmonary:
* DLCO at least 70% predicted
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No concurrent significant psychiatric or medical illness, including active infections, that would interfere with study therapy or increase risk
* No other malignancy within the past 5 years except curatively treated nonmelanomatous skin cancer, carcinoma in situ of the cervix, or superficial bladder cancer
PRIOR CONCURRENT THERAPY:
Chemotherapy:
* At least 4 weeks since prior systemic chemotherapy (at least 6 weeks since prior carmustine or mitomycin) and recovered
* No other concurrent chemotherapy or investigational antineoplastic drugs
Radiotherapy:
* At least 2 weeks since prior radiotherapy and recovered
* No concurrent radiotherapy
Surgery:
* At least 3 weeks since prior major surgery and recovered
Other:
* At least 4 weeks since other prior anticancer systemic therapy and recovered
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00005961
Study Brief:
Protocol Section:
NCT00005961