Clinical trial · Interventional
Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL
Open Label Pilot Study of Combination Therapy With Rosiglitazone and Bexarotene to Investigate a Possible Synergism in the Treatment of Cutaneous T-Cell Lymphoma
NCT00178841CI-TRIAL-00020968completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous T-cell Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Mycosis Fungoides | Mycosis Fungoides | ONTOLOGY_EXACT | 0.98 |
| Sezary Syndrome | Sezary Syndrome | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rosiglitazone and Bexarotene | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of Participants With a 50% Improvement in Baseline Skin Score
- timeFrame
- 16 weeks
- description
- mSWAT scoring. Range 0 to 400. Measured every 4 weeks.
Secondary outcomes (2)
- measure
- Quality of Life Evaluations
- timeFrame
- baseline and every 4 weeks
- description
- FACT-G, Functional Assessment of Cancer Therapy-General (quality-of-life scale) 0= worst 108=best
- measure
- Pruritus Score
- timeFrame
- 16 weeks
- description
- 10-cm visual analog scale, 10= worst, 1=best
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (11)
- BACKGROUNDBunn 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
- BACKGROUNDKoh 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
- BACKGROUNDDuvic 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
- BACKGROUNDZhang 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
- BACKGROUNDCarr 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
- BACKGROUNDWang 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
- BACKGROUNDRaji 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.