Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study

Cutaneous T-Cell Lymphoma Clinical Trial

Official title:

Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00779896
• Other study ID #: McG 0722
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: October 22, 2008
• Last updated: October 22, 2008
• Start date: October 2008
• Est. completion date: December 2012

Study information

• Verified date: October 2008
• Source: McGill University
• Contact: David Roberge
• Phone: 514-934-1934
• Email: david.roberge[@]muhc.mcgill.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This is an open label, prospective study to evaluate therapeutic potential of Tazarotene 0.1% cream for the treatment of Stage I-IIA CTCL. Patients with Stage I-IIA disease are enrolled into the study. Tazarotene will be used for up to 24 weeks and patients will be followed for up to 12 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with Stage I-IIA CTCL must be at least 18 years of age with a skin biopsy prior to enrolment confirming the diagnosis of mycosis fungoides.

Exclusion Criteria:

• Patients with Stage >IIA CTCL at the time of enrolment

• Women who are pregnant or planning to get pregnant, or unable/unwilling to use adequate contraception

• Patients who were treated with topical retinoid therapy in the past 3 months

• Patients who received any systemic CTCL therapy or systemic corticosteroid therapy within 30 days of the study start date

• Patients who were treated with systemic isotretinoin or bexarotene within 3 months prior to the study start date, systemic acitretin within 2 years prior to study start date

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cutaneous T-Cell Lymphoma
• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous

Intervention

Drug:
• Tazarotene
Topical 0.1 cream - apply to lesions on alternate days and at 2 week interval increase to once-daily application, if tolerated.

Locations

Country	Name	City	State
Canada	McGill University	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Partial response (PR) is defined as some improvement (25%-50%);significant evidence of disease remains or disease has not changed from baseline condition (<25%);no new clinically abnormal(>1.5 cm)lymph nodes,<25% progression of existence		unknown	Yes