Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL

NCT00178841 | Completed Phase 2 Results

• 1 other identifier: 050416
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cutaneous T-cell Lymphoma; Mycosis Fungoides; Sezary Syndrome

Keywords

Cutaneous T-cell Lymphoma; CTCL; Mycosis Fungoides; Sezary Syndrome; Bexarotene; Targretin; Rosiglitazone; Avandia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a 50% Improvement in Baseline Skin Score

  mSWAT scoring. Range 0 to 400. Measured every 4 weeks.

  16 weeks

Secondary Outcomes (2)

• Quality of Life Evaluations

  baseline and every 4 weeks

• Pruritus Score

  16 weeks

Interventions

Rosiglitazone and Bexarotene DRUG

rosiglitazone added to bexarotene capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-5227, United States

Location

Related Publications (11)

• 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.

  PMID: 8085692 BACKGROUND

• 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.

  PMID: 8522490 BACKGROUND

• 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.

  PMID: 11331325 BACKGROUND

• 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.

  PMID: 15245439 BACKGROUND

• 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.

  PMID: 14962523 BACKGROUND

• 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.

  PMID: 14759393 BACKGROUND

• 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.

  PMID: 12502676 BACKGROUND

• 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.

  PMID: 15781673 BACKGROUND

• 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.

  PMID: 445521 BACKGROUND

• 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.

  PMID: 9207472 BACKGROUND

• Shapiro PE. Advances in the histologic diagnosis of cutaneous T-cell lymphoma. Adv Dermatol. 1996;11:255-84; discussion 285. No abstract available.

  PMID: 8718481 BACKGROUND

Related Links

• Pubmed link to article

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome

Interventions

Rosiglitazone; Bexarotene

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: John Zic, MD
• Organization: Vanderbilt University Dermatology

john.zic@vanderbilt.edu

615-322-6485

Study Officials

• John A Zic, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine/Dermatology

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: June 1, 2005
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: February 17, 2016
• Results First Posted: February 17, 2016

Record last verified: 2016-01

Locations

US (1)