Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL

This study has been completed.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00178841
First received: September 12, 2005
Last updated: October 17, 2007
Last verified: October 2007
  Purpose

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.


Condition Intervention Phase
Cutaneous T-Cell Lymphoma
Mycosis Fungoides
Sezary Syndrome
Drug: Rosiglitazone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Pilot Study of Combination Therapy With Rosiglitazone and Bexarotene to Investigate a Possible Synergism in the Treatment of Cutaneous T-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Skin score calculated monthly at clinic visits.

Secondary Outcome Measures:
  • The safety and tolerability of combination therapy with bexarotene and rosiglitazone assessed every two weeks via laboratory testing and every four weeks via quality of life evaluations.

Enrollment: 10
Study Start Date: June 2005
Study Completion Date: March 2007
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 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 PPARγ (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178841

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-5227
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: John A Zic, MD Vanderbilt University
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00178841     History of Changes
Other Study ID Numbers: 050416
Study First Received: September 12, 2005
Last Updated: October 17, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Cutaneous T-cell Lymphoma
CTCL
Mycosis Fungoides
Sezary Syndrome
Bexarotene
Targretin
Rosiglitazone
Avandia

Additional relevant MeSH terms:
Lymphoma
Mycoses
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rosiglitazone
Bexarotene
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014