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