Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Lymphoma, T-Cell, Cutaneous

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

Cutaneous T-cell Lymphoma

Dermatologic Agents

All Drugs and Chemicals

Tazarotene

Keratolytic Agents

Topical 0.1 cream - apply to lesions on alternate days and at 2 week interval increase to once-daily application, if tolerated.

David Roberge

Penny Chipman

Crystal Lameira

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.

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

McGill University

Dr. David Roberger

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Musculoskeletal Diseases

Mouth and Tooth Diseases

Diseases and Abnormalities at or Before Birth

Carcinoma

Syndrome

Facies

Carcinoma, Basal Cell

Skin Neoplasms

Basal Cell Nevus Syndrome

Nevus, Pigmented

Nevus

Cysts

Odontogenic Cysts

Jaw Cysts

Bone Cysts

Neoplasms, Glandular and Epithelial

Neoplasms, Basal Cell

Neoplastic Syndromes, Hereditary

Bone Diseases

Bone Diseases, Developmental

Jaw Diseases

Stomatognathic Diseases

Congenital Abnormalities

Abnormalities, Multiple

Genetic Diseases, Inborn

Nevoid Basal Cell Carcinoma Syndrome

Tazarotene is a member of the acetylenic class of retinoids.

tazarotene

Ervin Epstein, MD

David R. Bickers, MD

RATIONALE: Drugs used in chemotherapy, such as tazarotene, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying topical tazarotene to see how well it works in treating patients with basal cell skin cancer and basal cell nevus syndrome on the face.

OBJECTIVES:

* Determine whether topical tazarotene, administered over a period of 18 months as a chemopreventive agent, reduces the incidence of basal cell carcinomas (BCCs) on treated skin in patients with basal cell nevus syndrome (BCNS).
* Expand and refine chemopreventive strategies in patients with BCNS who are at high risk for the development of BCCs.

OUTLINE: This is an open-label, multicenter study.

Patients apply topical tazarotene cream to the face once daily for 18 months in the absence of unacceptable toxicity.

Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Face

A Phase II Single Arm Open-Label Clinical Trial of Chemotherapy of BCC's With Tazarotene 0.1% in Subjects With Basal Cell Nevus Syndrome

The primary endpoint used to evaluate tazarotene efficacy for BCC chemotherapy was the complete response (CR) rate, defined as the complete visible disappearance of a patient's "target" lesion during the the 18 months of tazarotene application and its failure to recur during the ensuing 18-months. We defined surgical removal of a target lesion as a treatment failure. The primary endpoint was assessed based on intention to treat analysis such that any subject who underwent the baseline evaluation and applied at least 1 dose of tazarotene was included in the analysis. Drop-outs were considered non-responders. A priori treatment success for tazarotene was defined as a CR rate of at least 50%, and treatment failure was defined as a CR rate of 25% or less.

National Cancer Institute (NCI)

UCSF Benioff Children's Hospital Oakland

This is a 36 month, multi-center, single arm, open label clinical study design

Tazarotene Cream

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Ervin H Epstein Jr., MD

N=2 participants excluded from analysis: N=1 due to revised BCNS diagnosis and N=1 because unable to confirm administration of at least one dose of tazarotene.

Complete Response Rate

Time to Lesion Clearance

Time to Progression

Estimated Duration of Complete Response

Overall Response at Treated Lesions

Overall Study

Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.

Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.

placebo

RATIONALE: Drugs used in chemotherapy, such as tazarotene, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This randomized phase II trial is comparing two different schedules of topical tazarotene and topical placebo to see how well they work in treating patients with basal cell skin cancer and basal cell nevus syndrome on the chest.

OBJECTIVES:

Primary

* To expand and refine chemopreventive strategies in individuals with basal cell nevus syndrome (BCNS) on the chest and back, who are at high risk for the development of basal cell carcinomas (BCCs).
* To determine whether tazarotene 0.1% cream applied to the chest for two years will reduce the numbers of basal cell carcinomas (BCCs) observed, as compared to the number expected, based on changes in BCC numbers observed during months 0-12.

Secondary

* To compare the difference in total BCC burden (measured as the total lesion surface area) between chest and back over various time points and aggregated intervals of interest.
* To determine whether there are any detectable wash-in or wash-out periods for the tazarotene effects.
* Explore the use of a random effects model for longitudinal analysis of total lesions over time.

OUTLINE: This is a multicenter study. Patients are randomized into 1 of 2 arms.

* Arm I: Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients apply vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest in the absence of disease progression or unacceptable toxicity.

Treated chest and untreated back is evaluated at 3 month intervals for 36 months.

Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Chest and Back

A Phase II Randomized, Double-Blind, Vehicle-Controlled, Crossover Clinical Trial of Tazarotene 0.1% and Vehicle Cream Each Applied Once-Daily for 12 or 24 Months in Subjects With Basal Cell Nevus Syndrome

Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.

placebo : Applied to the skin

tazarotene : Applied to the skin

Arm I

Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.

placebo : Applied to the skin

tazarotene : Applied to the skin

Arm II

Total

Non-compliance and large drop-out rates leading to small numbers of data analyzed.

Raj Prasad

Number of Participants With Reduction in the Observed Numbers of Basal Cell Carcinomas ≥ 9 mm² in Diameter

Parameters of Safety: Number of Participants With Adverse Events According to NCI CTCAE v3.0

0.1% tazarotene cream first, then placebo

Vehicle (placebo) first, then 0.1% tazarotene cream

First Intervention (12 Months)

Second Intervention (24 Months)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study	NCT00779896	Cutaneous T-Cel...	Tazarotene	18 Years -	McGill University
Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study	NCT00779896	Cutaneous T-Cel...	Tazarotene	18 Years -	McGill University
Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Face	NCT00489086	Neoplastic Synd...	tazarotene	18 Years - 75 Years	UCSF Benioff Children's Hospital Oakland
Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Chest and Back	NCT00783965	Skin Carcinoma	tazarotene placebo	18 Years - 75 Years	UCSF Benioff Children's Hospital Oakland
Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Face	NCT00489086	Neoplastic Synd...	tazarotene	18 Years - 75 Years	UCSF Benioff Children's Hospital Oakland
Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Chest and Back	NCT00783965	Skin Carcinoma	tazarotene placebo	18 Years - 75 Years	UCSF Benioff Children's Hospital Oakland

Spots Global Cancer Trial Database for tazarotene

Every month we try and update this database with for tazarotene cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tazarotene

Every month we try and update this database with for tazarotene cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tazarotene cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.