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:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
NCT ID:
NCT00004106
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed mycosis fungoides or Sezary syndrome
* Stage IB-IVB disease
* Must have failed at least one prior systemic therapy
* Generalized erythroderma allowed
* Measurable disease and at least one indicator lesion OR evaluable disease for erythrodermic patients only
* Prior radiotherapy to areas of measurable disease allowed if disease progression is present in the site or if measurable disease is present outside irradiation port
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2 OR
* WHO 0-2
Life expectancy:
* At least 3 months
Hematopoietic:
* WBC at least 3,000/mm\^3
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 2.2 mg/dL
* SGOT or SGPT no greater than 2 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2 times ULN
Renal:
* Creatinine no greater than 2.0 mg/dL
Cardiovascular:
* No New York Heart Association class III or IV heart disease
* No clinically significant peripheral venous insufficiency
Other:
* HIV negative
* No poorly controlled diabetes mellitus
* No acute infection requiring IV antibiotics
* No other medical condition that would prevent ingestion or absorption of oral medication
* No other neoplasm within the past 5 years except curatively treated squamous cell or basal cell skin cancer, melanoma in situ, or carcinoma in situ of the cervix
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior biologic therapy and recovered
* No concurrent growth factors or epoetin alfa
Chemotherapy:
* At least 4 weeks since prior chemotherapy and recovered
Endocrine therapy:
* At least 4 weeks since prior topical steroids
Radiotherapy:
* See Disease Characteristics
* At least 2 weeks since prior radiotherapy for local control or palliation and recovered
Surgery:
* Recovered from prior major surgery
Other:
* No other concurrent investigational drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00004106
Study Brief:
Protocol Section:
NCT00004106