A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma
Trial ID or NCT#
NCT00476554
Status
NOT RECRUITING
Purpose
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).
Official Title
A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
- * 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
Exclusion Criteria:
- * Receiving systemic steroids* Receiving topical or systemic retinoids or vitamin A* Receiving radiotherapy, biological therapy,or any other investigational agents* Uncontrolled intercurrent illness* Pregnant or lactating women* Known to be HIV-positive* Active hepatitis B and/or hepatitis C infection
Investigator(s)
Youn H Kim
Dermatologic oncologist,
Cutaneous oncology specialist,
Dermatologist
The Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma Research and Professor, by courtesy, of Medicine (Oncology)
Contact us to find out if this trial is right for you.
Contact
Daniel Navi
6507362300
View on ClinicalTrials.gov
