Phase 2
N=4
Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL
Cutaneous T-cell Lymphoma · Mycosis Fungoides · Sezary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00178841 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Number of Participants With a 50% Improvement in Baseline Skin Score — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rosiglitazone and Bexarotene (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Mar 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a 50% Improvement in Baseline Skin Score |
— | — |
| SECONDARY Quality of Life Evaluations |
86.25 | — |
| SECONDARY Pruritus Score |
5.7 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00178841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.