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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2011

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • McGill University
  • Provider of Information About this Clinical Study
    • Dr. David Roberger, McGill University
  • Overall Official(s)
    • David Roberge, Principal Investigator, Montreal General Hospital
  • Overall Contact(s)
    • David Roberge, 514-934-1934, david.roberge@muhc.mcgill.ca

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.