Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Carcinoma in Situ

Bowen's Disease

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Cohort A: STP705 10 μg dose, intradermal injection, given once a week for up to 6 weeks

Cohort B: STP705 20 μg dose, intradermal injection, given once a week for up to 6 weeks

Cohort C: STP705 30 μg dose, intradermal injection, given once a week for up to 6 weeks

Cohort D: STP705 60 μg dose, intradermal injection, given once a week for up to 6 weeks

Cohort E: STP705 120 μg dose, intradermal injection, given once a week for up to 6 weeks

STP705

Kush Dhody, MBBS, MS, CCRA

Brian Berman, MD, PhD

This is an open label, dose escalation study to evaluate the safety and efficacy of intralesional injection of STP705 in adult patients with Cutaneous Squamous Cell Carcinoma in situ (isSCC, Bowen's disease). The purpose of this trial is to evaluate the safety, tolerability and efficacy of various doses of STP705 administered as Intralesional injection in subjects with isSCC.

Goals:

* To determine the safe and effective recommended dose of STP705 for the treatment of isSCC.
* Analysis of biomarkers common to isSCC formation pathway including TGF-β1 and COX-2.

This open label, dose escalation study is designed to evaluate the safety and efficacy of various doses of STP705 administered as an intralesional injection in subjects with cutaneous in situ squamous cell carcinoma (isSCC).

The primary objective of this study is to evaluate the safety, tolerability, and efficacy of various doses of STP705 administered as an Intralesional injection in subjects with cutaneous squamous cell carcinoma in situ skin cancer (isSCC). This study seeks to establish a safe and effective recommended dose of STP705 for the treatment of isSCC. Expression of biomarkers common to the isSCC formation pathway, including TGF-β1 and COX-2, will be evaluated.

The primary endpoint will be the proportion of participants with histological clearance of treated isSCC lesion at the End of Treatment (EOT). Histological clearance (HC) will be defined as the absence of detectable evidence of isSCC tumor cell nests as determined by central pathology review.

Secondary endpoints will include i) time to histological clearance of treated isSCC lesion over the 6 week treatment period, ii) proportion of participants with complete clinical clearance of treated isSCC lesion based on investigator assessment at the End of Treatment (EOT), iii) time to complete clinical clearance of treated isSCC lesion based on investigator assessment over the 6 week treatment period, and iv) the change in size of the treated isSCC lesion over the 6 week treatment period.

Safety and tolerability will be assessed by the number of incidence of adverse events (AEs) and serious adverse events (SAEs); the incidence of AEs and SAEs leading to discontinuation of trial medication; the incidence and severity of Local Skin Response (LSR); hypopigmentation and hyperpigmentation following treatment; and the tolerability of repeated Intralesional administration of STP705 as assessed by investigator-evaluation of injection site reactions for all patients and within each cohort.

In addition, safety measures will include clinically relevant changes or new abnormal findings in laboratory values, vital signs, electrocardiograms (ECGs), and physical examination variables.

25 adult patients are planned to be enrolled in the study. They will be divided equally among 5 cohorts (10, 20, 30, 60 and 120 μg dose levels) of 5 subjects each. Enrollment of the first two subjects in each dosing cohort will be staggered by at least 48 hours. Participants in the first cohort will attend the study center once weekly for an injection of STP705 into the isSCC lesion. The participants will receive injections of STP705 once a week for up to 6 weeks. The clinician will evaluate the tumor for clinical changes and reduction in size at each treatment visit for up to 6 weeks. If during the 6 weeks of treatment there is complete clinical clearance of the tumor, the treatments will end. At the End of Treatment visit, the residual tumor, or former tumor location will be excised for analysis. In the absence of dose limiting toxicities (DLT), the subsequent cohorts will receive increasing doses of STP705, following the same schedule of administration as the first cohort.

If any of the SAEs or dose limiting toxicities outlined above has occurred, the Data Safety Monitoring Board (DSMB) will conduct independent review of the data and will make a final decision for dose escalation to the next cohort.

Participants in the first cohort will attend the study center once weekly for an injection of STP705 into the isSCC lesion. The participants will receive injections of STP705 once a week for up to 6 weeks. The clinician will evaluate the tumor for clinical changes and reduction in size at each treatment visit for up to 6 weeks. If during the 6 weeks of treatment there is Complete Clinical Clearance of the tumor, the treatments will end. At the End of Treatment visit, the residual tumor, or former tumor location, will be excised for analysis. In the absence of dose limiting toxicities (DLT), the subsequent cohorts will receive increasing doses of STP705, following the same schedule of administration as the first cohort.

Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With isSCC

An Open Label, Dose Escalation Study to Evaluate the Safety and Efficacy of Intralesional Injection of STP705 in Adult Patients With Cutaneous Squamous Cell Carcinoma in Situ (isSCC)

Proportion of participants with histological clearance of treated isSCC lesion at the End of Treatment (EOT).

Histological clearance (HC) will be defined as the absence of detectable evidence of isSCC tumor cell nests as determined by central pathology review.

Change in size of the treated isSCC lesion over the 6 week treatment period. A base line assessment of lesion size will be made by investigator at T1 (first visit, Day 0). The change in size will be assessed every week until the surgical excision of isSCC at the End of Treatment visit (EOT, Day 42) .

Amarex Clinical Research

Sirnaomics

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Skin Neoplasms

Facies

Disease Attributes

Pharmaceutical Solutions

All Drugs and Chemicals

Dermatologic Agents

Aminolevulinic Acid

Photosensitizing Agents

20 participants will be enrolled to this arm

Participants will have their facial isSCC prepped then treated with Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick® Applicators) (ALA), followed by blue light therapy administered for 16 minutes and 40 seconds to deliver the total desired light dose to the isSCC lesion.

Aminolevulinic Acid 20% Topical Solution with Blue Light

Clinical Coordinator

Clinical Research Coordinator

Mark S. Nestor, MD, PhD

Mark S Nestor, M.D., Ph.D.

Mark S Nestor, MD, PhD

The goal of this clinical trial is to test how safe and effective it is to treat early form of cancer cells found in the upper skin layer of the face, using a light-sensitive cream used in combination with a light source.

The main questions this trial aims to answer are:

* to confirm using laboratory testing, how much of the affected facial skin cancer section the treatment was able to remove, and;
* seeing how many participants had no remaining affected facial skin cancer sections after treatment.

Participants who qualify will be asked to complete 12 visits in total and will receive a total of two treatments, after voluntarily consent has been given.

In the study, participants will be asked to complete the following:

* Provide basic personal information (including date of birth, gender, race and ethnicity)
* Provide their medical/ surgical history and perform a medical exam (including but not limited to physical exam, skin type, vital signs, height, weight and urine pregnancy test collection)
* Follow study rules such as avoiding certain medications and treatments
* Allow photographs of the area of skin cancer being treated on the face
* Provide information on any medications, treatments or reactions that started after the study began
* Allow two treatments on the skin cancer area of the face using a light-sensitive cream used in combination with a light source
* Allow clinical documentation of the treatment, such as how well the treatment was tolerated, any skin reaction or side effects
* Allow surgery to remove the skin cancer area from the face for Laboratory testing

To qualify for this trial, participants must:

* be an adult (18 years of age or older)
* give voluntary written consent
* have a recently diagnosed (less than six months from first visit) skin cancer area on the face that meets surgery size requirements
* be willing to follow study instructions and complete study requirements, including not using non-approved lotions and creams on the treatments areas
* (if female) not be pregnant before and during the study and agree to use acceptable forms of birth control
* confirm they are not sensitive to any of the study treatment ingredients

All surgery samples collected from the participants towards the end of the study will be sent to a laboratory for testing. All photographs of the treatment area collected during the study will be used as study data.

All participants have the right to refuse further participation in the study at any time.

Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (isSCC)

An Investigator Initiated Study to Evaluate the Safety and Efficacy of Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick®) (ALA) + Blue Light in the Treatment of Facial Cutaneous Squamous Cell Carcinoma in Situ (isSCC)

Histological clearance is defined as the absence of detectable evidence of isSCC tumor cell nests by the central pathology reports

Complete Clinical Clearance will be measured by the Investigator and is defined as when there is no clinically visible lesion remaining at the site.

Observations and changes noted in the aesthetic appearance (Erythema, Flaking/ Scaling, Crusting, Swelling, Vesiculation/ Pustulation, Erosion/ Ulceration) of the treated isSCC lesion will each be graded on a scale of 0 to 4, with 0 as no presence and 4 as a severe outcome.

Sun Pharmaceutical Industries Limited

The Center for Clinical and Cosmetic Research

Director

PEP005

Robert Rosen, Dr.

The purpose of this study is to determine whether the topical application of PEP005 is safe and effective for the treatment of cutaneous squamous cell carcinoma in situ (SCCIS, Bowen's disease).

Squamous cell carcinomas (SCCs) are a common skin problem largely caused by long term sun exposure. Current treatments include surgery, curettage/desiccation and some topical pharmaceutical therapies, which are often cosmetically disfiguring. Non-invasive alternative therapy for treatment of SCC lesions is thus being researched. Sap from the plant Euphorbia peplus has been used for many years in Australia as a "folk" remedy to treat a number of skin conditions. The active component of Euphorbia peplus has been isolated and made into a gel applied directly to the skin by Peplin Ltd. To date, three well-controlled studies with PEP005 gel in humans have been completed. In the first and second completed studies, sixteen (1st study) and sixty-four (2nd study) patients received one or two applications of PEP005 0.0025% or 0.01% or 0.05% or vehicle gel to actinic keratoses. In the third completed study, sixty patients received two applications of PEP005 0.0025% or 0.01% or 0.05% or vehicle gel to superficial basal cell carcinomas. Results from all studies show good tolerance and evidence of activity.

The current study is designed to evaluate the efficacy and safety of two applications of 0.05% PEP005 gel in patients with SCCIS on the extremities, trunk or face. Approximately 24 patients are planned to be included from multiple Australian centers. Patients will have two visits for treatment application and will return for check-up visits the day after the first application and several times thereafter for 2-3 months.

Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Cutaneous Squamous Cell Carcinoma In Situ

Multi-centre, Open-label Study to Determine the Safety and Efficacy of PEP005 0.05% Topical Gel in Patients With Cutaneous Squamous Cell Carcinoma In Situ (SCCIS, Bowen's Disease)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With isSCC	NCT04293679	Bowen's Disease Cutaneous Squam...	STP705	18 Years -	Sirnaomics
Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (isSCC)	NCT06159842	Facial Cutaneou...	Aminolevulinic ...	18 Years -	The Center for Clinical and Cosmetic Research
Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Cutaneous Squamous Cell Carcinoma In Situ	NCT00329121	Carcinoma, Squa...	PEP005	18 Years -	Peplin
Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With isSCC	NCT04293679	Bowen's Disease Cutaneous Squam...	STP705	18 Years -	Sirnaomics
Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (isSCC)	NCT06159842	Facial Cutaneou...	Aminolevulinic ...	18 Years -	The Center for Clinical and Cosmetic Research
Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Cutaneous Squamous Cell Carcinoma In Situ	NCT00329121	Carcinoma, Squa...	PEP005	18 Years -	Peplin

Spots Global Cancer Trial Database for cutaneous squamous cell carcinoma in situ