Symptoms and General Pathology

All Conditions

Pain

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Fentanyl

Analgesics, Opioid

Narcotics

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

Fentanyl Transdermal Therapeutic System (TTS)

Alza Corporation Clinical Trial

The purpose of this study is to evaluate the safety and effectiveness of continuous use of TTS fentanyl (a transdermal patch delivering the narcotic pain reliever fentanyl) for the treatment of chronic cancer pain.

Moderate to severe pain is experienced by about one-third of cancer patients during the intermediate stage of their disease. Currently used medications for the treatment of moderate to severe pain due to cancer often provide inadequate pain relief and require repeated oral administration of a narcotic. Providing prolonged, safe and effective pain relief on a continuous basis would be a major therapeutic advance in the management of cancer pain. This is an open-label pilot study to evaluate the safety and effectiveness of the fentanyl Transdermal Therapeutic System (TTS) in the management of chronic pain in patients with cancer. The initial dose of the fentanyl transdermal patch is calculated based upon the equi-analgesic potency ratio of the narcotic used prior to study entry. Four dosage strengths of the fentanyl transdermal patch are available as study medication, with a nominal delivery rate of 100, 75, 50 and 25 micrograms of fentanyl per hour. Multiple transdermal patches are worn when higher doses are required. Morphine sulfate is available as needed as rescue medication to treat breakthrough pain. After the initial application, the dose is titrated for each patient within a hospital setting over the course of 3 days, or as long as is necessary to achieve adequate pain control. Changes in dose during titration occur no more frequently than once every 24 hours. After an appropriate dose is reached, the transdermal patch is replaced every 72 hours with a new transdermal patch, applied to a fresh skin site. When discharged, patients enter a 3-week program of twice weekly nursing visits to monitor patient progress. Patients are evaluated at designated time intervals for pain intensity, vital signs, and serum fentanyl concentration. Records are kept of all concomitant medications administered during the study and any adverse events. After completion of the 3-week program, patients are given the opportunity to remain on the fentanyl Transdermal Therapeutic System (TTS) for long-term treatment of their chronic pain.

The TTS (fentanyl) transdermal patch starting dose is calculated based upon the equi-analgesic potency ratio of the narcotic used prior to study entry, titrated as needed to achieve adequate pain control. The patch is replaced every 72 hours. The treatment phase is 3 weeks.

Efficacy of the Fentanyl Transdermal Therapeutic System (TTS) in the Management of Pain in Patients With Cancer

Efficacy of TTS Fentanyl in the Management of Pain in Patients With Malignancy - Study III

Alza Corporation, DE, USA

Neoplasms

Skin and Connective Tissue Diseases

Carcinoma

Skin Neoplasms

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Antineoplastic Agents

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Immunocompetent and immuno-incompetent subjects will receive the MNA-D patch on 4 subsequent visits for a 20 minute time period at each application and will include patients who have competent immune systems with cSCC meeting all other inclusion/exclusion criteria and patients considered immuno-incompetent post transplant with cSCC meeting all other inclusion/exclusion criteria.

The Microneedle array patch is loaded/prepared with a total dose of 50 micrograms of Doxorubicin and is applied to a single selected cSCC remnant for a period of 20 minutes for a total of 4 weekly applications

Microneedle Array Doxorubicin (MNA-D)

Charity L Ruhl, LPN

Nicolena Verardi

Nicolena Verardi, PA-C

Oleg E Akilov, MD, PhD

Louis D Falo, MD, PhD

Melissa M Pugliano-Mauro, MD

Timothy Patton, DO

Jason Luke, MD

The purpose of this study is to test a new method of experimental treatment for cutaneous squamous cell skin cancer, using small adhesive-like patches (a micro-needle applicator or MNA for short), which have dozens of very small micro-needles loaded with extremely low doses of doxorubicin, a chemotherapy agent. The overall goal of this study is to test the safety and effectiveness of these patches. The investigators have established the highest tolerated dose at 50 micrograms in a previous study for a different type of cancer that affects the skin. The investigators will thoroughly evaluate the skin where the patches are applied.

This study will evaluate a novel approach to the treatment of cutaneous squamous cell cancer (cSCC) of patients diagnosed previously by skin biopsy with cSCC utilizing a dissolvable microneedle array (MNA) delivery device that is used to directly and specifically deliver a drug to the tumor microenvironment for skin cancer therapy. The investigators will utilize MNAs to deliver a well-characterized, potent chemotherapeutic agent (doxorubicin) to kill topically accessible, cutaneous SCC cells. In addition to directly killing cancer cells, doxorubicin is known to induce an immunologic cell death with the potential to simultaneously convert a cutaneous neoplasm into a highly potent patient specific immunogen capable of inducing innate, adaptive, and tumor specific effector and memory immune responses. Importantly, doxorubicin is currently in clinical use with a well-established safety profile. It is anticipated that use of the MNA-Doxorubicin (MNA-D) delivery system will enable direct and specific delivery of chemotherapy to the tumor, thereby avoiding any potential for systemic toxicity. The study will be conducted using two groups: one group will consist of patients with immunocompetent immune systems and the second group will consist of patients who have had an organ transplant and are considered immunoincompetent.efficacy and safety evaluation. The first phase is now completed. Following a screening/baseline phase, the MNA-D patch application and assessment visits will occur from week 0 through week 3, followed by a rest week and at week 5, up to week 8, a final follow up visit will take place. At the final follow up visit, the remaining cSCC lesion will be removed in a standard of care manner to ensure that all tissue margins are clear of the cSCC.

This is an open-label, comparative 2-cohort design

Microneedle Array Plus Doxorubicin in Cutaneous Squamous Cell Cancer (cSCC)

Phase Ib/II Study of Micro-needle Array Containing Doxorubicin in Immune Competent or Immune-suppressed Patients With Cutaneous Squamous Cell Carcinoma

Evaluated by assessing adverse events grade 2 or higher related to the MNA-D intervention

Percentage of tumor clearance of the area directly under the patch is measured..

Percentage of tumor clearance from the entire cSCC lesion treated by the patch is measured including the area directly covered by the MNA and uncovered area of the treated lesion. .

To provide a quantitative assessment of cSCC reduction after treatment, the remnant of cSCC tumors will be excised at week 5-8 and evaluated independently by 2 dermatopathologists in the blinded fashion. The depth of the cSCC will be measured.

Flow cytometry will evaluate in-vivo tumor immune responses in the blood and will analyze total immune activity for increases and/or decreases in T cell populations of interest and other immune cells (e.g., MDSCs, NK cells, B cells, macrophages, dendritic cells) that could influence the frequency and phenotype of these populations.

Flow cytometry will evaluate in-vivo tumor immune responses in the excised tumor tissue and will analyze total immune infiltrates for increases and/or decreases in T cell populations of interest and other immune cells (e.g., MDSCs, NK cells, B cells, macrophages, dendritic cells) that could influence the frequency and phenotype of these populations.

To provide a quantitative assessment of cSCC reduction after treatment, the remnant of cSCC tumors will be excised at week 5-8 and evaluated independently by 2 dermatopathologists in the blinded fashion. The percentage of reduction in comparison to the original tumor will be reported.

Luminex will evaluate in-vivo tumor immune responses for 65 selected serum biomarkers using a multiplex Luminex 100 (Bio-Rad Bio-Plex System) including G-CSF, GM-CSF, IFN-α, IFN-γ, IL-1β, IL-1RA, IL-2, IL-2R, IL-4, IL-5, IL-6, IL- 7, IL-8, IL-10, IL-12, IL-13, IL-15, IL-17, TNF-α, eotaxin, IP-10, MCP-1, MIG, MIP-1α, MIP-1β, RANTES, EGF, FGF-basic, HGF, and VEGF.

Serum SCC-Ag levels will evaluate in-vivo tumor immune responses in the blood

Luminex will evaluate in-vivo tumor tissue immune responses for 65 selected serum biomarkers using a multiplex Luminex 100 (Bio-Rad Bio-Plex System) including G-CSF, GM-CSF, IFN-α, IFN-γ, IL-1β, IL-1RA, IL-2, IL-2R, IL-4, IL-5, IL-6, IL- 7, IL-8, IL-10, IL-12, IL-13, IL-15, IL-17, TNF-α, eotaxin, IP-10, MCP-1, MIG, MIP-1α, MIP-1β, RANTES, EGF, FGF-basic, HGF, and VEGF.

Serum SCC-Ag levels will evaluate in-vivo tumor immune responses in the excised tumor tissue from baseline to week 8

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy of the Fentanyl Transdermal Therapeutic System (TTS) in the Management of Pain in Patients With Cancer	NCT00269737	Pain Cancer	Fentanyl Transd...	18 Years -	Alza Corporation, DE, USA
Efficacy of the Fentanyl Transdermal Therapeutic System (TTS) in the Management of Pain in Patients With Cancer	NCT00269737	Pain Cancer	Fentanyl Transd...	18 Years -	Alza Corporation, DE, USA
Microneedle Array Plus Doxorubicin in Cutaneous Squamous Cell Cancer (cSCC)	NCT05377905	Cutaneous Squam... Skin Cancers - ...	Microneedle Arr...	18 Years -	University of Pittsburgh

Spots Global Cancer Trial Database for patch

Every month we try and update this database with for patch 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 patch

Every month we try and update this database with for patch 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 patch 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.