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 @ 9:38 PM
Ignite Modification Date:
2025-12-24 @ 9:38 PM
NCT ID:
NCT02482532
Eligibility Criteria:
Inclusion Criteria:
* Metastatic, surgically unresectable melanoma or newly diagnosed melanoma of any stage, where the patient is unable to receive or complete standard therapy
* Life expectancy of at least 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2
* Laboratory Values
* absolute neutrophil count \> 500 microliters (mcL)
* platelet \> 50,000 mcL
* serum aspartate aminotransferase (AST) \< 5 x institutional upper limit of normal (IULN)
* total bilirubin \< 3 x IULN
* serum creatinine \< 3 x IULN
* Pulse oximetry of \> 95% on room air.
* Must have recovered from the toxic effects of all prior chemotherapy
Exclusion Criteria:
* Patients with rapidly progressive disease.
* Patient is currently receiving any investigational drugs
* Current cardiomegaly or bilateral pulmonary infiltrates on chest radiograph, pulmonary metastatic lesions are allowed
* Patients must not have tumor in a location where enlargement could cause airway obstruction
* Patient is pregnant or lactating
* History of hypersensitivity reactions to murine protein-containing products.
* Currently receiving immunosuppressive drugs such as corticosteroids (excluding topical treatment), tacrolimus or cyclosporin
* Received any tumor vaccines within previous six weeks
* Known hypersensitivity to rat monoclonal antibodies
* History of severe allergic reaction to Hepatitis B vaccine, Polio vaccine or Tetanus, Diphtheria, Pertussis vaccine (DTP, Tdap, DT or Td).
* Allergy to baker's yeast or other components of the vaccines.
* History of allergy to the antibiotics Neomycin, Streptomycin or Polymyxin B
* History of coma, long/multiple seizures within 7 days after DTP or Tdap, unless a cause other than the vaccine was indicated.
* Melanoma involvement of the central nervous system
* Chemotherapy given within the last 28 days
* Presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
66 Years
Study:
NCT02482532
Study Brief:
Protocol Section:
NCT02482532