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 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT00398450
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic melanoma
* At least one lesion appropriate for 3 separate punch or core needle biopsies
* Must have received and failed ≥ 1 prior systemic treatment for metastatic disease
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST and ALT \< 2 times ULN
* Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known allergies to azacitidine, interferon alfa, benzyl alcohol, or mannitol
* No uncontrolled infection
* No known HIV positivity
* No hepatitis B or hepatitis C infection
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 3 weeks since prior systemic therapy
* More than 4 weeks since prior radiotherapy to target lesions with evidence of progression
* No concurrent radiotherapy to target lesions
* No concurrent oral or IV corticosteroids
* Topical creams or ocular steroid drops are allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00398450
Study Brief:
Protocol Section:
NCT00398450