Status:
COMPLETED
Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL
Lead Sponsor:
Vanderbilt University
Conditions:
Cutaneous T-cell Lymphoma
Mycosis Fungoides
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
Treatment options for CTCL include both skin-directed and systemic therapies. Topical treatments are effective for early-stage disease that is localized to the skin. However, disease involving the lym...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00178841
Start Date
June 1 2005
End Date
March 1 2007
Last Update
February 17 2016
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-5227