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 @ 12:01 PM
Ignite Modification Date:
2025-12-24 @ 12:01 PM
NCT ID:
NCT00724061
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed mycosis fungoides/Sezary syndrome
* Stage IB-IVA disease
* Erythrodermic disease allowed
* Measurable disease
* One or more indicatory lesions must be designated prior to study entry
PATIENT CHARACTERISTICS:
* ECOG/WHO performance status 0-1
* Life expectancy ≥ 3 months
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 75,000/mm³
* WBC ≥ 3,000/mm³
* Serum creatinine ≤ 2.0 mg/dL
* Total serum bilirubin ≤ 2.2 mg/dL
* Serum AST and ALT ≤ 2 times upper limit of normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Patients must be disease free of prior malignancies for ≥ 5 years except currently treated squamous cell or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or surgically removed melanoma in situ of the skin (stage 0), with histologically confirmed free margins of excision
* No history of seizure disorder or severe heart disease
* No acute infections
* Diagnosed depression allowed with receiving appropriate care for depression
PRIOR CONCURRENT THERAPY:
* No prior psoralens with ultraviolet light A or interferon alfa therapy
* More than 4 weeks since prior topical therapy, systemic chemotherapy, or biologic therapy
* More than 4 weeks since prior surgery and fully recovered
* At least 1 week since prior antibiotics
* No other concurrent standard or investigational topical and systemic antipsoriatic or anticancer therapies including radiation, steroids, retinoids, nitrogen mustard, thalidomide, or other investigational agents
* No concurrent topical agents except emollients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00724061
Study Brief:
Protocol Section:
NCT00724061