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Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL

Primary Purpose

Cutaneous T-cell Lymphoma, Mycosis Fungoides, Sezary Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rosiglitazone and Bexarotene
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous T-cell Lymphoma focused on measuring Cutaneous T-cell Lymphoma, CTCL, Mycosis Fungoides, Sezary Syndrome, Bexarotene, Targretin, Rosiglitazone, Avandia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vanderbilt University Medical Center

Outcomes

Primary Outcome Measures

Number of Participants With a 50% Improvement in Baseline Skin Score
mSWAT scoring. Range 0 to 400. Measured every 4 weeks.

Secondary Outcome Measures

Quality of Life Evaluations
FACT-G, Functional Assessment of Cancer Therapy-General (quality-of-life scale) 0= worst 108=best
Pruritus Score
10-cm visual analog scale, 10= worst, 1=best

Full Information

First Posted
September 12, 2005
Last Updated
January 20, 2016
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT00178841
Brief Title
Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous T-cell Lymphoma, Mycosis Fungoides, Sezary Syndrome
Keywords
Cutaneous T-cell Lymphoma, CTCL, Mycosis Fungoides, Sezary Syndrome, Bexarotene, Targretin, Rosiglitazone, Avandia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rosiglitazone and Bexarotene
Intervention Description
rosiglitazone added to bexarotene capsules
Primary Outcome Measure Information:
Title
Number of Participants With a 50% Improvement in Baseline Skin Score
Description
mSWAT scoring. Range 0 to 400. Measured every 4 weeks.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Quality of Life Evaluations
Description
FACT-G, Functional Assessment of Cancer Therapy-General (quality-of-life scale) 0= worst 108=best
Time Frame
baseline and every 4 weeks
Title
Pruritus Score
Description
10-cm visual analog scale, 10= worst, 1=best
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A Zic, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-5227
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8085692
Citation
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.
Results Reference
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PubMed Identifier
8522490
Citation
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.
Results Reference
background
PubMed Identifier
11331325
Citation
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.
Results Reference
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PubMed Identifier
15245439
Citation
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.
Results Reference
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PubMed Identifier
14962523
Citation
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.
Results Reference
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PubMed Identifier
14759393
Citation
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.
Results Reference
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PubMed Identifier
12502676
Citation
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.
Results Reference
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PubMed Identifier
15781673
Citation
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.
Results Reference
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PubMed Identifier
445521
Citation
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.
Results Reference
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PubMed Identifier
9207472
Citation
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.
Results Reference
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PubMed Identifier
8718481
Citation
Shapiro PE. Advances in the histologic diagnosis of cutaneous T-cell lymphoma. Adv Dermatol. 1996;11:255-84; discussion 285. No abstract available.
Results Reference
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Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/17184879
Description
Pubmed link to article

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Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL

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