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 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT00651157
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed malignant melanoma
* All melanomas, regardless of origin, are allowed
* Metastatic disease
* Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20mm by conventional techniques or as ≥ 10 mm by spiral CT scan
* Must have ≥ 1 metastatic lesion that can be safely biopsied
* Must have received ≥ 1 prior treatment for metastatic disease
* Not a candidate for curative surgery for metastatic disease
* No known brain metastases
* Eastern Cooperative Oncology Group performance status 0-2
* Life expectancy \> 12 weeks
* Total White Blood Cell (WBC) ≥ 3,000/mcL
* Absolute neutrophil count ≥ 1,500/mcL
* Platelet count ≥ 100,000/mcL
* Hemoglobin ≥ 9 g/dL
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Aspartate Aminotransferase (AST) ≤ 2.5 times ULN
* Creatinine ≤ 1.5 times ULN
* Troponin-T normal
* Left ventricular ejection fraction (LVEF) ≥ 50% by ECHO or MUGA
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Agrees to provide blood and tissue samples for the mandatory translational research component of the study
* Must be able to avoid direct contact with pregnant or nursing women, infants, and immuno compromised individuals during study and for ≥ 3 weeks following the last dose of study agent
* No concurrent uncontrolled illness including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris, cardiac arrhythmia, or myocardial infarction within the past year
* Psychiatric illness/social situation that would preclude study compliance
* No known HIV positivity
* Patients with a clinical history suggestive of an immuno compromised status are required to undergo HIV testing
* More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas) and recovered
* More than 2 weeks since prior radiotherapy, immunotherapy, or treatment with small molecule cell cycle inhibitors
* No other concurrent investigational agents
* No other concurrent anticancer therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00651157
Study Brief:
Protocol Section:
NCT00651157