Cutaneous T-Cell Lymphoma
Conditions
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
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.
Interventions
DRUGTazarotene
Topical 0.1 cream - apply to lesions on alternate days and at 2 week interval increase to once-daily application, if tolerated.
Sponsors
McGill University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Canada
Contacts
Primary ContactDavid Roberge
Outcome results
None listed