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 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 12:59 AM
NCT ID:
NCT00715793
Eligibility Criteria:
Inclusion Criteria:
* Patients who have non-resectable Stage IIIB or stage IV metastatic melanoma that have progressed despite prior therapies.
* Life expectancy of at least 12 weeks.
* ECOG performance status of 0, 1 and 2.
* ≥18 years of age.
* Patients who have not received any other chemotherapeutic, biological or investigational agent within 28 days of study drug administration.
* First line and active brain metastases (metastatic lesions to the brain that have been adequately treated with surgery and/or appropriate radiation therapy and that have documented stability for \>4 weeks or \>2 weeks if treated with stereotactic radiosurgery, remain eligible)
Exclusion Criteria:
* Any evidence of renal dysfunction (proteinuria, estimated creatinine clearance from serum creatinine test of \<60 ml/min).
* Impaired hepatic function (liver enzymes greater than twice the upper limit of normal or bilirubin \> 2.0 except in patients with Gilbert's syndrome).
* Prior treatment with alkylating agents (including TMZ and DTIC).
* Active brain metastases (metastatic lesions to the brain that have been adequately treated with surgery and/or appropriate radiation therapy and that have documented stability for \>4 weeks remain eligible).
* Active infections or serious general medical conditions.
* Female patients of child-bearing age who are not on adequate contraception, or are pregnant or breast-feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00715793
Study Brief:
Protocol Section:
NCT00715793