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 @ 2:03 PM
Ignite Modification Date:
2025-12-24 @ 2:03 PM
NCT ID:
NCT00518895
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed diagnosis of melanoma
* Progressive disease that is not surgically resectable, or metastatic Stage IV
* Low-normal LDH, defined as ≤ 0.8 times the upper limit of normal
* No prior chemotherapy
* Measurable disease
* ECOG performance status ≤ 1
* At least 4 weeks and recovery from effects of major prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy
* Prior immunotherapy allowed
* Adequate organ function
Exclusion Criteria:
* Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense treatment
* Primary ocular or mucosal melanoma
* Bone-only metastatic disease
* History or presence of brain metastasis or leptomeningeal disease
* Significant medical disease other than cancer
* Organ allograft
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00518895
Study Brief:
Protocol Section:
NCT00518895