Phase II Trial to Evaluate the Efficacy of Topical Bexarotene Gel in Patients With Parapsoriasis

NCT00322296 | Terminated Phase 2

• 1 other identifier: 00-031
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Parapsoriasis is a term that refers to a precursor stage of cutaneous T-cell lymphoma (CTCL)/mycosis fungoides(MF). Complete responses (clearing) of early presentations of CTCL/MF 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.

Conditions

Parapsoriasis

Keywords

Parapsoriasis; Cutaneous T-cell lymphoma; Mycosis fungoides; Bexarotene; Retinoids

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoints (outcome) are the skin lesion responses determined by the Composite Assessment of Index Lesion Disease Severity following up to sixteen weeks of treatment

Secondary Outcomes (2)

• Secondary efficacy endpoints (outcomes) include the disease response to treatment as determined by percentage of total body surface area involvement and physician global assessment following up to sixteen weeks of treatment.

• Also, antitumor host response as determined by immunohistochemistry in pre and post treatment skin biopsies.

Interventions

Bexarotene 1% gel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A clinical and histologic diagnosis of parapsoriasis (T0 CTCL)
• Age 18 years or older.
• Acceptable laboratory studies
• Must be free of serious concurrent illness.
• Women of child-bearing potential must have negative serum pregnancy test prior to the initiation of treatment.

You may not qualify if:

• Topical or systemic therapies within four weeks of entry in the study.
• Participation in any other investigational drug study within thirty days of entry in this study.
• Oral retinoid therapy for any indication within three months of entry in the study.
• Participation in any other study using topical retinoid therapy.
• Pregnancy or active breast-feeding.
• Serious known concurrent medical illness or infection.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• Ligand Pharmaceuticals: collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Parapsoriasis; Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides

Interventions

Bexarotene; Gels

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; 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)

Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Stuart R. Lessin, M.D.

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 4, 2006
• First Posted: May 5, 2006
• Study Start: April 1, 2001
• Primary Completion: July 1, 2004
• Study Completion: August 1, 2004
• Last Updated: April 16, 2013

Record last verified: 2006-05

Locations

US (1)