Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study
Information source: McGill University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cutaneous T-Cell Lymphoma
Intervention: Tazarotene (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: McGill University Official(s) and/or principal investigator(s): David Roberge, Principal Investigator, Affiliation: Montreal General Hospital
Overall contact: David Roberge, Phone: 514-934-1934, Ext: 48080, Email: david.roberge@muhc.mcgill.ca
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.
Clinical Details
Official title: Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
David Roberge, Phone: 514-934-1934, Ext: 48080, Email: david.roberge@muhc.mcgill.ca
McGill University, Montreal, Quebec H2W 1S6, Canada; Recruiting Penny Chipman, Phone: 514-398-1444, Email: penny.chipman@mcgill.ca Crystal Lameira, Phone: 514-398-2229, Email: crystal.lameira@mcgill.ca
Additional Information
Starting date: October 2008
Last updated: October 22, 2008
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