A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma
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ClinicalTrials.gov Identifier: NCT00476554
(slow accrual and financial resource limitation)
This is an open label, randomized phase II study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell lymphoma (CTCL) who have had progressive, recurrent, or persistent disease on or following 2 systemic therapies.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adult patients with advanced CTCL
Have had at least 2 systemic therapies
Must have evaluable disease
Eastern Cooperative Oncology Group performance status 0-2
Adequate bone marrow, hepatic and renal function
At least 3 weeks from prior therapies
Not receiving topical steroids or have been on a stable dose of topical steroids for at least 2 weeks
Able to swallow capsules
At least 3 weeks from major surgery
Agree to practice effective contraception
Able to understand and willing to sign the informed consent form
Receiving systemic steroids
Receiving topical or systemic retinoids or vitamin A
Receiving radiotherapy, biological therapy,or any other investigational agents