Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00178841
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2005-09-12
Brief Title:
Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 CTCLBexarotene binds the RXRRetinoid X Receptorinside 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 RosiglitazoneRosiglitazone 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
Bexarotene has been approved by the FDA for the treatment of Cutaneous T-Cell Lymphoma CTCLBexarotene binds the RXRRetinoid X Receptorinside 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 RosiglitazoneRosiglitazone 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None