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

This study is currently recruiting participants.

Verified October 2008 by McGill University

First Received on October 22, 2008. No Changes Posted

Sponsor:	McGill University
Information provided by:	McGill University
ClinicalTrials.gov Identifier:	NCT00779896

Purpose

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.

Condition	Intervention	Phase
Cutaneous T-Cell Lymphoma	Drug: Tazarotene	Phase I Phase II

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Tazarotene

U.S. FDA Resources

Further study details as provided by McGill University:

Primary Outcome 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 [ Time Frame: unknown ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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

Other Names:

Tazorac (trademark name)
Tazarotenic Acid

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779896

Contacts

Contact: David Roberge

514-934-1934 ext 48080

david.roberge@muhc.mcgill.ca

Locations

Canada, Quebec
McGill University	Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: Penny Chipman 514-398-1444 penny.chipman@mcgill.ca
Contact: Crystal Lameira 514-398-2229 crystal.lameira@mcgill.ca

Sponsors and Collaborators

McGill University

Investigators

Principal Investigator:

David Roberge

Montreal General Hospital

More Information

No publications provided

Responsible Party:	Dr. David Roberger, McGill University
ClinicalTrials.gov Identifier:	NCT00779896 History of Changes
Other Study ID Numbers:	McG 0722
Study First Received:	October 22, 2008
Last Updated:	October 22, 2008
Health Authority:	Canada: Health Canada

Keywords provided by McGill University:

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

Additional relevant MeSH terms:

Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Tazarotene

Nicotinic Acids
Keratolytic Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012