Neoplasms

All Conditions

Carcinoma

Carcinoma, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Basal Cell

All Drugs and Chemicals

Tirbanibulin

Enzyme Inhibitors

Subjects will be given one study kit containing single-dose packets of Tirbanibulin Ointment 1% and instructed to topically apply to the treatment area once daily for 5 consecutive days. Subjects with unresolved lesion at d28 or d56 or d72 or d84 will be given an additional study kit containing single-dose packets of Tirbanibulin Ointment 1% and instructed to topically apply to the treatment area once daily for 5 consecutive days.

Philippe Bahadoran, PhD

Henri Montaudie, PhD

Philippe Bahadoran

philippe Bahadoran, PhD

his is a Phase 2, Single-Arm, Open-Label, Single Center, to Assess Efficacy and Safety of Tirbanibulin Ointment 1% in Adult Subjects with superficial basal cell carcinoma (sBCC) not arising on the face or scalp

This is a pilot study aimed at studying the efficacy and tolerance of a new topical treatment regimen in BCC. The number of 50 sBCC to be treated was established based on previous studies that have investigated the effectiveness of a topical regimen in sBCC. Considering that approximately 10% of BCCs will be wrongly included or not evaluable or will present with a deviation protocol major, a total of 55 sBCC will be included in the study.Inclusion Criteria :

* Age \> 18 years
* Histologically confirmed, primary, previously untreated, superficial basal cell carcinoma (sBCC) not arising on the face or scalp, ≤ 15 mm (large axis)

Exclusion Criteria :

* BCC of the face or scalp
* BCC of non-superficial subtype
* BCC with large axis \> 15mm
* Relapsing BCC
* Allergy to treatment
* Treatment with cryotherapy, imiquimod, PDT, or radiotherapy in the BCC area during the 6 months prior to the screening visit. Visits : 1) Selection visit = V0: if the patient meets the selection criteria, oral and written information will be given to him. If the patient signs the consent during this consultation, the inclusion visit will be carried out at the same time. 2) Inclusion visit and start of treatment = V1 (D1): for patients who have not signed their consent at the previous visit, consent will be collected • Verification of inclusion and non-inclusion criteria • Collection of medical and surgical history • Collection of previous and concomitant treatments • Clinical evaluation by visual inspection: measurement of the long axis, calculation of the surface to be treated (maximum treated surface for all sBCC should not exceed \> 25 cm2) • Realization of a layer with the limits of the lesion • Clinical photos • Examination by LC-OCT • Dispensing of Tirbanibulin for the treatment cycle (1 tube for up to 3 sBCC) • Explanation of the mode of application to the patient • First application performed on site • Giving the patient a notebook to record the applications of the product and local skin reactions. 3) Follow-up visit +/- retreatment = V2 (D28 ± 2 d) • Collection of adverse events and changes in concomitant treatments • Collection of local skin reactions in the patient notebook • Evaluation of local skin reactions • Clinical evaluation and by LC-OCT -\> In case of cure clinically and by LC-OCT (complete remission, CR) end of the study for the patient -\> In the absence of CR processing as in V1 -\> in case of a wound at the application site, the study will end for the patient and he will be treated according to standard recommendantions for• sBCC 4) Additional follow-up visits +/- retreatment = V3 (D56±2 days), V4 (D84+/-2d) : these visits will be conducted identically to V2. 5) Short-term efficacy visit = V5 (D112 +/- 2d): same as V2 w/o treatment with Tirbanibulin. Patients not in CR will terminate the study and will be treated according to standard recommendations for sBCC. 6) Long-term efficacy visit = V6 (M12): same as V2 w/o treatment with Tirbanibulin. All patients will terminate the study. Patients with relapse of their BCC will be treated according to standard recommendations for sBCC.

Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma

Open, Prospective Study Evaluating the Efficacy and Safety of 0.05% Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma

Type, frequency, severity and time to onset of adverse effects. Adverse effects will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) scale. Local adverse effects will be assessed by the LSR score.

Complete remission after the 1st, 2nd, 3rd or 4th cycle of Tirbanibulin (Klisiry®) in sBCC.

Centre Hospitalier Universitaire de Nice

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Antineoplastic Agents

Gemcitabine

BCG Vaccine

Antimetabolites

Group A received BCG instillation 14 days after II look-TURB:6 weekly instillations of Tice-strain BCG (Organon Teknika Corp.) as induction chemotherapy, with a dose of 5 x 108 CFU diluted in 50 mL of saline held in the bladder for 2 hours.

14 days after II look-TURB the patients received 6 weekly instillations of Gemcitabine (Gemzar, Eli Lilly SpA), using a dose of 2000 mg diluted in 50 mL of saline held in the bladder for 2 hours

6 weekly instillations of Tice-strain BCG (Organon Teknika Corp.) as induction chemotherapy, with a dose of 5 x 108 CFU diluted in 50 mL of saline held in the bladder for 2 hours.

gemcitabine

A significant number of patients with high risk superficial bladder cancer has progression to invasive disease. No consensus exists regarding the optimal treatment to decrease the recurrence and progression rate. The aim of this research is to evaluate the safety, tolerability and efficacy of adjuvant intravesical gemcitabine vs. BCG in the treatment of high-risk superficial bladder cancer

This was a prospective, randomized study conducted from 2004 to 2006 at a single tertiary urban teaching University Urological Department regarding sixty-four patients with high-risk superficial bladder cancer (pT1, and/or G3 and/or CIS), who were assigned to interventions (gemcitabine or BCG) by using random allocation 1:1. Group A, 32 patients, were treated weekly (6 weekly instillations) with BCG dose 5 x 108 CFU and then maintenance therapy at 3-6-12-18-24-30-36 months; Group B, 32 patients, received gemcitabine 2 gr/instillation on a weekly basis (6 weekly instillations), followed by maintenance therapy at 3-6-12-18-24-30-36 months.

Bacillus of Calmette and Guerin (BCG) Versus Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer

BCG vs. Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer: A Randomized Prospective Study

University Of Perugia

Mouth and Tooth Diseases

Rare Diseases

Carcinoma, Squamous Cell

Mouth Neoplasms

Oral Squamous Cell Carcinoma

Oral Cancer

Tongue Cancer

T1 T2 and T3 OSCC tumor, patients who have a recent evaluation cervico thoracic scanner in their medical files.

We will analyse the pre operative scannographic and MRI (if available) images, and the post operative pathological analyses.

The scanners will be reviewed by 2 well trained clinicians (one head and neck radiologist and one head and neck surgeon).

Then we will analyse the correlation between the radiological and the pathological analysis.

Radiologic and pathological review.

Leonard MEGUERDITCHIAN, MD

The aim of the study is to assess the good correlation and prediction of the DOI for the post-operative pathological results and prognosis.

Radio/Pathological Evaluation of Tongue Cancer Infiltration

An Evaluation of the Radio/Pathological Correlation of Depth Of Invasion for Oral Squamous Cell Carcinoma, a Retrospective Study in a University Hospital in Lyon

With a Bland Altman analysis we will assess the good correlation between the pre and post operatory mesures of the depth of invasion in the oral squamous cell carcioma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma	NCT06112522	Cell Carcinoma	Tirbanibulin	18 Years -	Centre Hospitalier Universitaire de Nice
Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma	NCT06112522	Cell Carcinoma	Tirbanibulin	18 Years -	Centre Hospitalier Universitaire de Nice
Bacillus of Calmette and Guerin (BCG) Versus Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer	NCT00696579	Bladder Cancer	BCG gemcitabine	18 Years - 75 Years	University Of Perugia
Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma	NCT06112522	Cell Carcinoma	Tirbanibulin	18 Years -	Centre Hospitalier Universitaire de Nice
Radio/Pathological Evaluation of Tongue Cancer Infiltration	NCT04821128	Oral Squamous Cell Carcinoma	Radiologic and ...	-	Hospices Civils de Lyon

Spots Global Cancer Trial Database for cell carcinoma