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

• Status: Terminated
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fox Chase Cancer Center
• Collaborator: Ligand Pharmaceuticals
• Treatments: Bexarotene

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.