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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT00057967
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed mycosis fungoides or Sézary syndrome
* Stage IB-IVB
* Measurable disease
* One or more indicator lesions
* No prior radiotherapy to areas of measurable disease unless there is clear disease progression at the site or measurable disease outside the area of prior radiotherapy
* Generalized erythrodermia patients with evaluable disease only are allowed
* Must have failed at least 1 prior systemic therapy
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
* AST or ALT 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
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No acute infection requiring intravenous antibiotics
* No other prior neoplasm except treated squamous cell or basal cell skin cancer, treated carcinoma in situ of the cervix, or other cancer that received surgical treatment only from which patient has been disease free for at least 5 years
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 4 weeks since prior biologic therapy
Chemotherapy
* More than 4 weeks since prior chemotherapy
Endocrine therapy
* More than 4 weeks since prior topical steroids
Radiotherapy
* See Disease Characteristics
* At least 2 weeks since prior radiotherapy (local control or palliative)
* No concurrent radiotherapy to any lesion
Surgery
* Recovered from prior major surgery
Other
* Recovered from prior therapy
* No other concurrent proven or investigational antineoplastic agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00057967
Study Brief:
Protocol Section:
NCT00057967