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

NCT00779896 | Unknown Phase 1

• 1 other identifier: McG 0722
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cutaneous T-Cell Lymphoma

Keywords

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; Stage I-IIA disease CTCL

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Tazarotene DRUG

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

Also known as: Tazorac (trademark name), Tazarotenic Acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

McGill University

Montreal, Quebec, H2W 1S6, Canada

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Interventions

tazarotene; tazarotenic acid

Condition Hierarchy (Ancestors)

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

Study Officials

• David Roberge

  Montreal General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Roberge

CONTACT

514-934-1934; david.roberge@muhc.mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 22, 2008
• First Posted: October 24, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: October 24, 2008

Record last verified: 2008-10

Locations

CA (1)