Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL
Completed · Phase 2
Conditions studied: Cutaneous T-cell Lymphoma, Mycosis Fungoides, Sezary Syndrome
In brief
The purpose of this trial is to determine if combination therapy with rosiglitazone and bexarotene might have a synergistic effect in the treatment of patients with CTCL.
Key facts
- Study ID
- NCT00178841
- Run by
- Vanderbilt University
- People needed
- 4
- Starts
- 2005-06-01
- Expected to finish
- 2007-03-01
- Last updated by the study team
- 2016-02-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with biopsy proven persistent or recurrent cutaneous cell lymphoma (CTCL) Stage IA-IVA
- Patients with a pathologic proven diagnosis of CTCL that is documented in the patient history.
- Patient has preserved organ function.
- Patient has an ECOG performance status between 0 - 2.
- Women of childbearing potential should be screened for pregnancy prior to treatment and utilize effective contraceptive methods (e.g. barrier) during treatment period.
- Patients over the age of 18 who are willing and able to provide Informed Consent
- The patient has been taking Targretin capsules for at least the last 4 months and the dose has remained relatively stable.
- The patient has had stable or progressive disease over the past 4 months.
- Patient has adequate laboratory parameters for liver and kidney function.
You may not qualify if…
- Patients with CD30+ Anaplastic Large Cell Lymphoma
- Patients with pathology consistent with peripheral T-cell lymphoma.
- Patients with Stage IVB (visceral involvement with CTCL).
- Patients with history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C infection.
- Patients with a diagnosis of congestive heart failure.
- Patients exhibiting significant edema or unstable cardiovascular disease.
- Patients with a fasting triglyceride level greater then 500mg/dl.
- Patients that have started any new treatment for CTCL in the past 4 months.
- Pregnant women will be excluded from the study.
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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