Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Diseases and Abnormalities at or Before Birth

Symptoms and General Pathology

Digestive System Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Carcinoma

Skin Neoplasms

Carcinoma, Squamous Cell

Keratoacanthoma

Muir-Torre Syndrome

Neoplasms, Squamous Cell

Syndrome

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Skin Diseases

Lynch Syndrome II

Colorectal Neoplasms

Colorectal Neoplasms, Hereditary Nonpolyposis

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Sebaceous Gland Diseases

Skin Diseases, Genetic

Antineoplastic Agents

All Drugs and Chemicals

Talimogene laherparepvec

Antineoplastic Agents, Immunological

The subject participation period will be approximately 48 weeks. This will include a screening visit, 4 injection visits and 5 follow up visits. Total length of study/patient is 8.5 to 10.5 months. TVEC will be administered by injection with a needle directly into one or more tumors.

Target lesions are identified and documented with measurements and photographs. Photographs will be taken with regional and close up view of the anatomical area and lesion.

Inject 0.5ml - 4ml (based on lesion size - section 7.1, Table 5) Talimogene laherparepvec at nominal concentration of 106 plaque forming units (PFU)/mL with approximately 1.15 mL in a 2 mL vial for the initial dose. This will be administered intralesionally to 1-3 cSCC lesions per anatomical site with a maximum of 5 injectable lesions per patient.

Injection of TVEC into target lesions - week 1-2

Target lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion.

Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected. Talimogene laherparepvec at nominal concentration of 108 PFU/mL withapproximately 1.15 mL in a 2 mL vial for the second and subsequent doses.

Injection of TVEC into target lesions 3wks after 1st injection

Target lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion.

Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected.Talimogene laherparepvec at nominal concentration of 108 PFU/mL with approximately 1.15 mL in a 2 mL vial for the subsequent doses.

Injection of TVEC into target lesions 2wks after 2nd injection

Target lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion.

Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected. Talimogene laherparepvec at nominal concentration of 108 PFU/mL with approximately 1.15 mL in a 2 mL vial for the subsequent doses.

Injection of TVEC into target lesions 2wks after 3rd injection

Clara Curiel, MD

This is single arm a Phase 2, single center study of talimogene laherparepvec (TVEC) to treat low risk cutaneous squamous cell carcinomas (cSCC).

The purpose of this study is to find out more about talimogene laherparepvec (also known as OncoVEXGM-CSF or IMLYGIC®) in people with a healthy immune system with confirmed low-risk squamous cell carcinoma. Usually, low-risk SCC is treated with a surgical procedure, but surgery can be challenging when patients have: multiple SCCs on their body, when the SCC is on a challenging place on the body to remove or when patients are older or have diseases that place them at risk for surgery related complications. Immune therapy is a treatment that uses certain parts of a person's immune system to fight disease. Immune therapy is a proven therapeutic approach in many cancers, including melanoma, another type of skin cancer.

Talimogene laherparepvec (TVEC) is made from a modified herpes simplex virus type 1 (HSV-1, the "cold sore" virus). The virus' genes were modified in a laboratory so that it produces a protein called human granulocyte macrophage colony-stimulating factor (GM-CSF), which multiplies and grows in tumor cells. Human GM-CSF is normally produced by various cells within the body and is used as a medicine to treat patients with white blood cell counts that are too low. This modified HSV-1 produces a protein that acts on tumor cells and stimulates the immune system. TVEC is administered by injection with a needle directly into one or more tumors and works by directly destroying cancer cells and enhancing immune response to destroy cancer cells.

Study of TVEC in Patients With Cutaneous Squamous Cell Cancer

A Single Arm Phase 2 Study of Talimogene Laherparepvec in Patients With Cutaneous Squamous Cell Cancer

The primary end point is to evaluate the overall response rate (ORR) defined as proportion of subjects who achieved complete response (CR) and partial response (PR) in the cSCC Target injected lesions (TILs).

1. Number of participants with events requiring the discontinuation of study drug

1. 75% or greater number of Target injection lesions (TILs) meeting criteria for withdrawal.
2. Identification of high-risk features in one or more TILs during study participation.
3. Persistent discomfort (consecutive weeks of lesion pain, burning, or itching of Grade 2 or more).

To measure time of response in cSCC TILs.

To measure the duration of overall response (DOR) of TILs.

Assess durable response rate (DRR) of TILs.

To measure the time to progression (TTP) of TILs

Overall response rate (ORR) (CR+PR) assessed by imaging technique (high frequency ultrasound).

Overall clinical response rate (CR+PR) of individual TILs with talimogene laherparepvec (not as overall subject response).

Overall clinical response rate (CR+PR) in cSCC Target non-injected lesion(s) (TNILs).

1. Number of safety adverse events (SAE) as assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) 4.0

a. Clinically significant laboratory values i. Clinically significant laboratory values are based on participant condition and side effect. These will vary and will be determined by the clinical judgement of the research healthcare provider. Note: laboratory values will be collected for initial participant screening and side effects only, no other clinical laboratory values are scheduled in this protocol.

Local effects on the tumor as assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) 4.0

1. Pain
2. Inflammation
3. Ulceration

Amgen

University of Arizona

Keratosis, Actinic

Keratosis

Keratosis, Seborrheic

Precancerous Conditions

Three of four selected SK lesions receive Nano-Pulse Stimulation treatment.

One of four SK lesions is randomized to not receiving Nano-Pulse Stimulation treatment.

The Pulse generator delivers electrical pulses (nanosecond duration) that are applied directly to targeted lesion using sterile treatment tips with micro-needles.

Nano-Pulse Stimulation (NPS)

Richard A Nuccitelli, PhD

The primary purpose of this trial is to evaluate Nano-Pulse Stimulation (NPS) to clear or remove Seborrheic Keratosis (SK) lesions from off-facial areas of healthy adult subjects.

Evaluate Nano-Pulse Stimulation (NPS) to clear or remove Seborrheic Keratosis (SK) lesions from off-facial areas of healthy adult subjects.

The specific objectives of this study are to:

* Document the non-treated appearance of off-face SKs.
* Evaluate the clearance of SKs in off-face locations post-treatment versus pre-treated appearance of the same lesion.
* Evaluate the clearance of the treated SKs at various points in time over several weeks following the initial procedure, compared to the pre-treated SKs.

Each subject served as their own control. Each subject had 4 lesions with 3 of the lesions serving in the Active Comparative Arm (Lesions treated with Nano-Pulse Stimulation) and 1 lesion serving as control not treated with Nano-Pulse Stimulation and assigned to No Intervention Arm.

A Reference Key was developed for 3 independent reviewers to use during their review of the full set (196 image pairs) of study photographs. The reference key included 2 representative photographs for each of the 4 possible scores used in the SK study (clear, mostly clear, partially clear, and not clear). The three independent reviewers were not principal investigators at enrolling centers.

Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study

Evaluation of Nano-Pulse Stimulation (NPS) in Patients With Seborrheic Keratosis

Total Number of treated SK lesions per participant rated as clear or mostly-clear by the Principal Investigator at each clinical site.

Pulse Biosciences, Inc.

Three of four selected SK lesions received Nano-Pulse Stimulation treatment.

Nano-Pulse Stimulation (NPS): The Pulse generator delivers electrical pulses (nanosecond duration) that are applied directly to targeted lesion using sterile treatment tips with micro-needles.

Nano-Pulse Stimulation (NPS) Treatment Arm

Three of four selected SK lesions receive Nano-Pulse Stimulation treatment.

Nano-Pulse Stimulation (NPS): The Pulse generator delivers electrical pulses (nanosecond duration) that are applied directly to targeted lesion using sterile treatment tips with micro-needles.

Nano-Pulse Stimulation (NPS) Lesion

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Baseline Analysis Population includes 58 Participants with 3 treated SK lesions and one SK lesion as an internal control for a total of 4 SK lesions per participants.

William A. Knape

Fifty-eight (58) participants with each participant having a total of 4 SK lesions, 3 treated and 1 serving as an internal untreated control.

Clearance of SK Lesions

Overall Study

Nano-Pulse Stimulation of targeted lesion.

Electrical pulses (nanosecond duration) applied directly to target SK lesions using sterile single-patient use treatment tips with microneedles.

Primary study objective is to evaluate the optimization of Nano-Pulse Stimulation (NPS) energy settings for lesion clearance of Seborrheic Keratosis (SKs) from off-facial areas of healthy adults.

* Evaluate lesion clearance rate of SKs in off-face locations post-treatment versus baseline using multiple sized treatment tips with microneedles.
* Evaluate the clearance of the treated SKs using multiple energy settings at various time points initial procedure, compared baseline.
* Evaluate skin effects and adverse event rate.

Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Optimization Study

Prospective, Open-Label, Multi-Center, Non-Significant Risk Study of Nano-Pulse Stimulation™ (NPS™) Technology in Healthy Adults With Seborrheic Keratosis

Degree of Clearance of SK lesion treated with NPS as rated by investigators.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of TVEC in Patients With Cutaneous Squamous Cell Cancer	NCT03714828	Squamous Cell C... Skin Cancer Keratoacanthoma Cutaneous Tumor Skin Cancer, Sq... Lesion Skin	Injection of TV... Injection of TV... Injection of TV... Injection of TV...	18 Years -	University of Arizona
Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study	NCT03846531	Lesion Skin Seborrheic Kera...	Nano-Pulse Stim...	18 Years - 75 Years	Pulse Biosciences, Inc.
Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Optimization Study	NCT04249115	Lesion Skin Seborrheic Kera... Skin Lesion Benign Skin Tum...	Nano-Pulse Stim...	21 Years - 75 Years	Pulse Biosciences, Inc.

Spots Global Cancer Trial Database for lesion skin

Every month we try and update this database with for lesion skin 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 lesion skin

Every month we try and update this database with for lesion skin 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 lesion skin 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.