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

October 22, 2008
October 22, 2008
October 2008
December 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study
Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study

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.

Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cutaneous T-Cell Lymphoma
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
December 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: David Roberge 514-934-1934 ext 48080 david.roberge@muhc.mcgill.ca
Canada
 
NCT00779896
McG 0722
No
Dr. David Roberger, McGill University
McGill University
Not Provided
Principal Investigator: David Roberge Montreal General Hospital
McGill University
October 2008

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