Open Label Pilot Study of Combination Therapy With Rosiglitazone and Bexarotene to Investigate a Possible Synergism in the Treatment of Cutaneous T-Cell Lymphoma
18 Years
N/A
Both
Cutaneous T-Cell Lymphoma, Mycosis Fungoides, Sezary Syndrome
Trial Information
Open Label Pilot Study of Combination Therapy With Rosiglitazone and Bexarotene to Investigate a Possible Synergism in the Treatment of Cutaneous T-Cell Lymphoma
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 lymph nodes or visceral sites can be palliated but rarely cured, even
with the most aggressive regimens of systemic chemotherapy. Unfortunately, current
treatment options at this stage only provide a short term response. Thus, it is important
that additional therapies are investigated to manage this malignancy.
Bexarotene has been approved by the FDA for the treatment of Cutaneous T-Cell Lymphoma
(CTCL).Bexarotene binds the RXR(Retinoid X Receptor)inside the cell, a receptor that forms
heterodimers with a multitude of other nuclear receptors. One of these is the PPARĪ³
(Peroxisome Proliferator Activator Receptor Gamma), a nuclear receptor that binds
Rosiglitazone.Rosiglitazone is an FDA approved antidiabetic agent of the Thiazolidinedione
class. Rosiglitazone increases insulin sensitivity and is useful in the treatment of type 2
diabetes. In vitro data suggest that rosiglitazone and bexarotene may act synergistically to
induce apoptosis in cell lines derived from patients with cutaneous T cell lymphoma (CTCL).
This pilot study will investigate this possible synergism in a small cohort of patients with
stable or progressive CTCL already being treated with bexarotene.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Skin score calculated monthly at clinic visits.
Principal Investigator
John A Zic, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Vanderbilt University
Authority:
United States: Food and Drug Administration
Study ID:
050416
NCT ID:
NCT00178841
Start Date:
June 2005
Completion Date:
March 2007
Related Keywords:
- Cutaneous T-cell Lymphoma
- Mycosis Fungoides
- Sezary Syndrome
- Cutaneous T-cell Lymphoma
- CTCL
- Mycosis Fungoides
- Sezary Syndrome
- Bexarotene
- Targretin
- Rosiglitazone
- Avandia
- Lymphoma
- Mycoses
- Mycosis Fungoides
- Sezary Syndrome
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
Name | Location |
|---|---|
| Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
