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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by McGill University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
McGill University
ClinicalTrials.gov Identifier:
NCT00779896
First received: October 22, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  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 1
Phase 2

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:
    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
  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 May 16, 2013