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

• Sponsor: McGill University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00779896
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Duration (Months): 50
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cutaneous T-Cell Lymphoma	Drug: Tazarotene	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study
• Study Start Date: Oct 1, 2008
• Anticipated Primary Completion Date: Dec 1, 2011
• Anticipated Study Completion Date: Dec 1, 2012

Outcome Measures

Primary Outcome Measures

1. 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 Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McGill University	Montreal	Quebec	Canada	H2W 1S6

Sponsors and Collaborators

• McGill University

Investigators

• Principal Investigator: David Roberge, Montreal General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00779896
• Other Study ID Numbers: McG 0722
• First Posted: Oct 24, 2008
• Last Update Posted: Oct 24, 2008
• Last Verified: Oct 1, 2008

• Keywords provided by , ,: 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
• Additional relevant MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous; Tazarotene

Study Results

No Results Posted as of Oct 24, 2008