Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322296
Status:
TERMINATED
Last Update Posted:
2013-04-16
First Post:
2006-05-04
Brief Title:
Phase II Trial to Evaluate the Efficacy of Topical Bexarotene Gel in Patients With Parapsoriasis
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
A Phase II Trial to Evaluate the Efficacy of Topical Bexarotene Gel in Patients With Parapsoriasis a Topical Chemoprevention Strategy for Cutaneous T-cell Lymphoma
Status:
TERMINATED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The response rate 58 had reached a statistical significant endpoint
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Parapsoriasis is a term that refers to a precursor stage of cutaneous T-cell lymphoma CTCLmycosis fungoidesMF Complete responses clearing of early presentations of CTCLMF have been shown to be associated with long-term survival and cure Induction of a complete response in parapsoriasis therefore would seem to be a desirable therapeutic endpoint Bexarotene 1 gel has been approved for treatment of cutaneous T-cell lymphoma mycosis fungoides The goal of this study is to evaluate the tolerability safety and efficacy of bexarotene 1 gel in patients with parapsoriasis
Detailed Description:
Parapsoriasis is a term that refers to a red scaling papulosquamous eruption on the skin characterized by its distribution trunk and proximal extremities asymptomatic nature and chronic course Histologically parapsoriasis is characterized by variable degrees of parakeratosis and epidermal spongiosis with a superficial sparse patchy lichenoid infiltrate of lymphocytes and varying degrees of epidermal involvement epidermotropism No definitive studies have defined its etiology or epidemiology
Historically the term parapsoriasis was introduced into the dermatology literature by Brocq in 1902 Brocq used the term to clinically characterize a variety of papulosquamous eruptions that were first reported in the late 19th century In 1905 he attempted to categorize parapsoriasis in relationship to other papulosquamous diseases of the skin In his model Brocq delineated a relationship between some variants of parapsoriasis parapsoriasis en plaques or large plaque parapsoriasis and mycosis fungoides or cutaneous T-cell lymphoma CTCL The first cases of mycosis fungoides MF were reported early in the 19th century Progressive stages of MF premycotic patch phase plaque phase and tumor phase were defined later in the 19th century while the neoplastic nature of the disease remained unknown Brocqs model sought to emphasize clinical similarities between some variants of parapsoriasis large plaque and early patch phase MF
Immunohistochemical IHC studies have demonstrated that parapsoriasis shares a similar immunophenotype with early stage CTCL in that the lymphocytic infiltrate is predominantly composed of CD4 lymphocytes Polymerase chain reaction PCR- based T-cell receptor TCR gene rearrangement studies have demonstrated that parapsoriasis is a lymphoproliferative disorder characterized by the detection of clonal populations of T-cells as is CTCL Knowledge of the natural history of parapsoriasis stems from a series of longitudinal outcome studies published over the last 40 years Progression to unequivocal CTCL ranged from 0 to 35 of parapsoriasis cases Typically cases associated with progression to CTCL tend to have larger plaques with clinical features of atrophy andor poikiloderma
Based on the clinicopathologic similarities of parapsoriasis and early stage CTCL the exact nosology of parapsoriasis has been challenged with a hypothesis that all variants of parapsoriasis large plaque small plaque and digitate are synonymous with early MF Nevertheless parapsoriasis is recognized as a distinct precursor stage T0N0M0 in the TNM staging schema of CTCL T0 CTCL is defined by the presence of lesions clinically andor histologically suggestive of CTCL
No definitive studies have been published regarding therapy of parapsoriasis When treated most patients are initiated empirically on topical steroids or phototherapy Typically patients will have partial responses andor relapse off any therapy A rational therapeutic strategy for parapsoriasis is lacking because there are no longitudinal studies that correlate treatment response and impact on progression to CTCL
Bexarotene is a resinoid a subclass of retinoids that binds preferentially to nuclear retinoic X receptors RXR and has therapeutic activity in CTCL Bexarotene 1 gel has been approved for treatment of CTCL and found to have up to a 63 response rate in Stage Ia to IIa CTCL The goal of this study was to evaluate the tolerability safety and efficacy of bexarotene 1 gel in patients with parapsoriasis and to evaluate the anti-tumor host response in pre- and post-treatment skin biopsies
Historically the term parapsoriasis was introduced into the dermatology literature by Brocq in 1902 Brocq used the term to clinically characterize a variety of papulosquamous eruptions that were first reported in the late 19th century In 1905 he attempted to categorize parapsoriasis in relationship to other papulosquamous diseases of the skin In his model Brocq delineated a relationship between some variants of parapsoriasis parapsoriasis en plaques or large plaque parapsoriasis and mycosis fungoides or cutaneous T-cell lymphoma CTCL The first cases of mycosis fungoides MF were reported early in the 19th century Progressive stages of MF premycotic patch phase plaque phase and tumor phase were defined later in the 19th century while the neoplastic nature of the disease remained unknown Brocqs model sought to emphasize clinical similarities between some variants of parapsoriasis large plaque and early patch phase MF
Immunohistochemical IHC studies have demonstrated that parapsoriasis shares a similar immunophenotype with early stage CTCL in that the lymphocytic infiltrate is predominantly composed of CD4 lymphocytes Polymerase chain reaction PCR- based T-cell receptor TCR gene rearrangement studies have demonstrated that parapsoriasis is a lymphoproliferative disorder characterized by the detection of clonal populations of T-cells as is CTCL Knowledge of the natural history of parapsoriasis stems from a series of longitudinal outcome studies published over the last 40 years Progression to unequivocal CTCL ranged from 0 to 35 of parapsoriasis cases Typically cases associated with progression to CTCL tend to have larger plaques with clinical features of atrophy andor poikiloderma
Based on the clinicopathologic similarities of parapsoriasis and early stage CTCL the exact nosology of parapsoriasis has been challenged with a hypothesis that all variants of parapsoriasis large plaque small plaque and digitate are synonymous with early MF Nevertheless parapsoriasis is recognized as a distinct precursor stage T0N0M0 in the TNM staging schema of CTCL T0 CTCL is defined by the presence of lesions clinically andor histologically suggestive of CTCL
No definitive studies have been published regarding therapy of parapsoriasis When treated most patients are initiated empirically on topical steroids or phototherapy Typically patients will have partial responses andor relapse off any therapy A rational therapeutic strategy for parapsoriasis is lacking because there are no longitudinal studies that correlate treatment response and impact on progression to CTCL
Bexarotene is a resinoid a subclass of retinoids that binds preferentially to nuclear retinoic X receptors RXR and has therapeutic activity in CTCL Bexarotene 1 gel has been approved for treatment of CTCL and found to have up to a 63 response rate in Stage Ia to IIa CTCL The goal of this study was to evaluate the tolerability safety and efficacy of bexarotene 1 gel in patients with parapsoriasis and to evaluate the anti-tumor host response in pre- and post-treatment skin biopsies
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