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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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Tazarotene
Dermatologic Agents
Keratolytic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014