Cutaneous T-Cell LymphomaPhase 1/2NCT00779896
Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study
A Phase 1/2 study testing Tazarotene in people with Cutaneous T-Cell Lymphoma, run by McGill University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T-Cell Lymphoma
- What is being tested?
- Tazarotene
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2008to Dec 2012
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McGill University
Montreal, Quebec, H2W 1S6
Penny Chipman, 514-398-1444, penny.chipman@mcgill.ca
Crystal Lameira, 514-398-2229, crystal.lameira@mcgill.ca
About this 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.
- Conditions
- Cutaneous T-Cell Lymphoma
- Being tested
- Tazarotene
- 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
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TazaroteneDrug
Also called Tazorac (trademark name), Tazarotenic Acid
Topical 0.1 cream - apply to lesions on alternate days and at 2 week interval increase to once-daily application, if tolerated.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2011 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T-Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Investigators
- David Roberge, Principal investigator, Montreal General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779896
- Sponsor's protocol ID
- McG 0722
- Status last verified
- Oct 2008
- First submitted
- 22 Oct 2008
- Last updated
- 24 Oct 2008
- Results posted
- No
- Data monitoring committee
- No