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

Primary Purpose

Cutaneous T-Cell Lymphoma

Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Tazarotene
Sponsored by
McGill University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous T-Cell Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McGill UniversityRecruiting

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
October 22, 2008
Last Updated
October 22, 2008
Sponsor
McGill University
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1. Study Identification

Unique Protocol Identification Number
NCT00779896
Brief Title
Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study
Official Title
Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
McGill University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tazarotene
Other Intervention Name(s)
Tazorac (trademark name), Tazarotenic Acid
Intervention Description
Topical 0.1 cream - apply to lesions on alternate days and at 2 week interval increase to once-daily application, if tolerated.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Roberge
Phone
514-934-1934
Ext
48080
Email
david.roberge@muhc.mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Roberge
Organizational Affiliation
Montreal General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Penny Chipman
Phone
514-398-1444
Email
penny.chipman@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Crystal Lameira
Phone
514-398-2229
Email
crystal.lameira@mcgill.ca

12. IPD Sharing Statement

Learn more about this trial

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

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