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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified October 2008 by McGill University.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT00779896

First Posted: October 24, 2008

Last Update Posted: October 24, 2008

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

McGill University

Tracking Information

First Submitted Date ^ICMJE

October 22, 2008

First Posted Date ^ICMJE

October 24, 2008

Last Update Posted Date

October 24, 2008

Start Date ^ICMJE

October 2008

Estimated Primary Completion Date

December 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Cutaneous T-Cell Lymphoma

Intervention ^ICMJE

Drug: Tazarotene

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

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Estimated Primary Completion Date

December 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Canada

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00779896

Other Study ID Numbers ^ICMJE

McG 0722

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Dr. David Roberger, McGill University

Study Sponsor ^ICMJE

McGill University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

David Roberge

Montreal General Hospital

PRS Account

McGill University

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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