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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT00560118
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic malignant melanoma, meeting the following criteria:
* Metastatic lymph nodes or skin allowing for surgical resection
* At least 1 metastatic lesion (lymph nodes, skin, visceral, brain)
* Measurable or evaluable disease
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* ANC \> 2 x 10\^9/L
* Platelet count \> 100 x 10\^9/L
* Transaminases ≤ 2.5 times normal
* Alkaline phosphate ≤ 2.5 times normal
* Total bilirubin normal
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No severe uncontrolled infection
* No other prior or concurrent malignancy (except basal cell or squamous cell carcinoma in situ of the cervix that was curatively treated)
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy
* At least 2 weeks since prior adjuvant therapy
* At least 4 weeks since prior radiotherapy
* At least 30 days since prior participation in another clinical trial
* No prior or concurrent prophylactic phenytoin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00560118
Study Brief:
Protocol Section:
NCT00560118