Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL
NCT ID: NCT00178841
Last Updated: 2016-02-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
4 participants
INTERVENTIONAL
2005-06-30
2007-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Rosiglitazone and Bexarotene
rosiglitazone added to bexarotene capsules
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Vanderbilt University
OTHER
Responsible Party
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John Zic
Associate Professor of Medicine/Dermatology
Principal Investigators
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John A Zic, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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References
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Bunn PA Jr, Hoffman SJ, Norris D, Golitz LE, Aeling JL. Systemic therapy of cutaneous T-cell lymphomas (mycosis fungoides and the Sezary syndrome). Ann Intern Med. 1994 Oct 15;121(8):592-602. doi: 10.7326/0003-4819-121-8-199410150-00007.
Koh HK, Charif M, Weinstock MA. Epidemiology and clinical manifestations of cutaneous T-cell lymphoma. Hematol Oncol Clin North Am. 1995 Oct;9(5):943-60.
Duvic M, Hymes K, Heald P, Breneman D, Martin AG, Myskowski P, Crowley C, Yocum RC; Bexarotene Worldwide Study Group. Bexarotene is effective and safe for treatment of refractory advanced-stage cutaneous T-cell lymphoma: multinational phase II-III trial results. J Clin Oncol. 2001 May 1;19(9):2456-71. doi: 10.1200/JCO.2001.19.9.2456.
Zhang C, Ni X, Konopleva M, Andreeff M, Duvic M. The novel synthetic oleanane triterpenoid CDDO (2-cyano-3, 12-dioxoolean-1, 9-dien-28-oic acid) induces apoptosis in Mycosis fungoides/Sezary syndrome cells. J Invest Dermatol. 2004 Aug;123(2):380-7. doi: 10.1111/j.0022-202X.2004.23207.x.
Carr A, Workman C, Carey D, Rogers G, Martin A, Baker D, Wand H, Law M, Samaras K, Emery S, Cooper DA; Rosey investigators. No effect of rosiglitazone for treatment of HIV-1 lipoatrophy: randomised, double-blind, placebo-controlled trial. Lancet. 2004 Feb 7;363(9407):429-38. doi: 10.1016/S0140-6736(04)15489-5.
Wang TD, Chen WJ, Lin JW, Chen MF, Lee YT. Effects of rosiglitazone on endothelial function, C-reactive protein, and components of the metabolic syndrome in nondiabetic patients with the metabolic syndrome. Am J Cardiol. 2004 Feb 1;93(3):362-5. doi: 10.1016/j.amjcard.2003.10.022.
Raji A, Seely EW, Bekins SA, Williams GH, Simonson DC. Rosiglitazone improves insulin sensitivity and lowers blood pressure in hypertensive patients. Diabetes Care. 2003 Jan;26(1):172-8. doi: 10.2337/diacare.26.1.172.
Demierre MF, Tien A, Miller D. Health-related quality-of-life assessment in patients with cutaneous T-cell lymphoma. Arch Dermatol. 2005 Mar;141(3):325-30. doi: 10.1001/archderm.141.3.325.
Bunn PA Jr, Lamberg SI. Report of the Committee on Staging and Classification of Cutaneous T-Cell Lymphomas. Cancer Treat Rep. 1979 Apr;63(4):725-8. No abstract available.
Willemze R, Kerl H, Sterry W, Berti E, Cerroni L, Chimenti S, Diaz-Perez JL, Geerts ML, Goos M, Knobler R, Ralfkiaer E, Santucci M, Smith N, Wechsler J, van Vloten WA, Meijer CJ. EORTC classification for primary cutaneous lymphomas: a proposal from the Cutaneous Lymphoma Study Group of the European Organization for Research and Treatment of Cancer. Blood. 1997 Jul 1;90(1):354-71.
Shapiro PE. Advances in the histologic diagnosis of cutaneous T-cell lymphoma. Adv Dermatol. 1996;11:255-84; discussion 285. No abstract available.
Related Links
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Pubmed link to article
Other Identifiers
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050416
Identifier Type: -
Identifier Source: org_study_id
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