Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Treatments: Bexarotene; Rosiglitazone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.