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 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT00626860
Eligibility Criteria:
Inclusion Criteria:
* patients with confirmed diagnoses of disseminated melanoma, with measurable and clearly progressive metastatic involevment
* Patients must be at least 18 years old
* Patients must have ECOG performance status 0-1 with greater than 9 week life expectancy
* Those patients with the following accessible tumor will be eligible: soft tissue, bone marrow or visceral lesions; Skin or superficial soft tissue, or lymph nodes amenable to resection under local anesthesia; Patients who require surgical procedures that are not considered significantly invasive but may require general anesthesia, such as thorascopic biopsy, laparascopic biopsy or mediastinal node biopsy may potentially be eligible; Malignant ascites or pleural effusion; Patients requiring major surgical intervention will be considered ineligible. Patients scheduled to undergo tumor resection for independent diagnostic or therapeutic indications may have tumor collected for the purposes of this study.
* Labs: WBC \>\_ 2.0 x 10x3/uL, Bilirubin \<\_2.0 mg/dL, Creatine \<\_ 2.0mg/dL
* Women of childbearing age must have a negative pregnancy test and adequate contraception method(s) must be documented
* All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines
Exclusion Criteria:
* Patients must not have received other immunotherapy treatment in the past four weeks prior to study entry
* Patients must not have received chemotherapy for three weeks prior to the first vaccination
* Patients must be without evidence of active CNS disease
* Patients must not have clinically significant autoimmune disease
* Patients must be HIV negative
* Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
* Patients requiring corticosteroids for either melanoma related or co-morbid illness
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00626860
Study Brief:
Protocol Section:
NCT00626860