A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma

Trial ID or NCT#

NCT00476554

Status

not recruiting iconNOT 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:
  1. * 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:
  1. * 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
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Investigator(s)

Sunil Arani Reddy
Sunil Arani Reddy
Medical oncologist, Cutaneous oncology specialist
Clinical Associate Professor, Medicine - Oncology
Richard Hoppe
Richard Hoppe
Radiation oncologist
Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology

Contact us to find out if this trial is right for you.

Contact

Daniel Navi
6507362300

View on ClinicalTrials.gov