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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cutaneous T-Cell Lymphoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Time Frame:

unknown

Safety Issue:

Yes

Principal Investigator

David Roberge

Investigator Role:

Principal Investigator

Investigator Affiliation:

Montreal General Hospital

Authority:

Canada: Health Canada

Study ID:

McG 0722

NCT ID:

NCT00779896

Start Date:

October 2008

Completion Date:

December 2012

Related Keywords:

  • Cutaneous T-cell Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous

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