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A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma
Not Recruiting
Trial ID: NCT00476554
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
Stanford Investigator(s)
Sunil Arani Reddy
Clinical Associate Professor, Medicine - Oncology
Richard Hoppe
Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology
Eligibility
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
Intervention(s):
drug: Sapacitabine
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Daniel Navi
6507362300