Symptoms and General Pathology

All Conditions

Heart and Blood Diseases

Neoplasms

Substance Related Disorders

Rare Diseases

Syndrome

Heart Diseases

Tricuspid Valve Insufficiency

Carcinoid Tumor

Malignant Carcinoid Syndrome

Serotonin Syndrome

Carcinoid Heart Disease

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Heart Valve Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Carcinoid Syndrome

Neuroendocrine Tumor

Neuroepithelioma

Herbal and Botanical

All Drugs and Chemicals

Kava

Participants who have carcinoid heart disease with severe symptomatic tricuspid regurgitation and with a significant backflow in the caval and hepatic veins will be treated with the implantation of the Transcatheter Tricuspid Valved Stent Graft

All participants meeting the inclusion and none of the exclusion criteria will be enrolled. A custom-made Transcatheter Tricuspid Valved Stent Graft based on CT to define anatomic dimensions will be made. The system consists of a custom-made valved stent graft delivery system, a custom-made valved stent graft bioprosthesis and a loading system. The bioprosthesis is self-expanding and consists of a stent graft spanning from the inferior vena cava to the superior vena cava and a lateral bicuspid valve element made of thin porcine pericardial leaflets requiring a low closing pressure, and Nitinol support structures. The participants will undergo a minimally invasive, catheter-based procedure to implant the bioprosthesis which is delivered through a 24 French delivery system via transfemoral access. The device can be repositioned and is retrievable.

Transcatheter Tricuspid Valved Stent Graft

Andreas Baumbach

The purpose of this investigation is to see if the TRICENTO Valved Stent Graft implant reduces tricuspid regurgitation (TR) and improves the symptoms and quality of life in 15 participants with carcinoid heart disease, and who are not able to have a new valve via a surgical procedure.

After being informed about the study and the potential risks and benefits, participants who provide written consent will be screened to make sure they fulfil the study entry requirements. This will involve a detailed medical history, a CT and an echo scan.

Once it is agreed that the participant is suitable for the study, a custom-made TRICENTO valve is prescribed and made. Participants need to be admitted to hospital for the TRICENTO device to be implanted. Before the device is implanted the participant will have further tests and measurements completed eg ECG, a Cardiac MRI, physical measurements such as height, weight and blood pressure, blood tests, questionnaires and measuring how far they can walk in 6 minutes.

The device is implanted in a cath lab procedure which should take about 30-60 minutes in total. Participants should be discharged from hospital about 2-3 days later after recovery and further echocardiogram, blood tests and questionnaires.

Follow up visits are at 1 month and 6 months after the procedure. The following measurements such as an ECG, echocardiogram, and physical measurements (height, weight and blood pressure), some blood tests, questionnaires and measuring how far they can walk in 6 minutes will be repeated at 1 month and at 6 months after the procedure. A cardiac MRI will also be repeated at 6 months after the procedure. All these tests are to measure whether the TRICENTO valve improves the participant's heart function, symptoms and quality of life.

Single-arm, prospective single-centre interventional study to test safety and efficacy of the Tricento Transcatheter Tricuspid Valved Stent Graft

Investigation of a Transcatheter Tricuspid Valved Stent Graft in Patients With Carcinoid Heart Disease

Single Centre, Prospective, Single Arm Open Label Series of a Transcatheter Tricuspid Valved Stent Graft System for the Reduction of Tricuspid Regurgitation and Improved Patient Reported Outcomes in Patients With Carcinoid Heart Disease

with a 35% change (reduction) in the V wave pressure in the Inferior Vena Cava (IVC)

* The number of procedural complications (re-interventions related to the device or access procedure, major vascular or bleeding complication (VARC), cardiac death during hospital stay (max 7 days)
* Rate of death all causes

1. measure of ankle circumference (cm)
2. assessment of oedema scored as: none = 0, ankle = 1, shin = 2, thigh = 3, anasarca = 4

Count of number of hospital admissions for heart failure

Measure Kansas City Cardiomyopathy Questionnaire scores for all patients

Royal Free Hospital NHS Foundation Trust

Queen Mary University of London

Nervous System Diseases

Recurrence

Brain Neoplasms

Supratentorial Neoplasms

Disease Attributes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Brain Tumor, Childhood

Mitogens

Enrolled patients must proceed to surgery for tumor resection and Ommaya placement into the resection cavity within 14 days of enrollment. Starting dose of 3x10\^6/m\^2 of TGFβi NK cells (first dose) may be administered at least 14 days after the Ommaya reservoir placement, and may not start until all acute surgical complications have resolved (maximum of 6 weeks after enrollment). TGFβi NK cell infusions through the Ommaya reservoir will occur once weekly for three weeks followed by one rest week. If patients have stable or improved disease, patients may continue to receive therapy for a total of 12 cycles.

If no safety or toxicity events are demonstrated by the starting dose cohort, enrolled patients in the next dosing cohort must proceed to surgery for tumor resection and Ommaya placement into the resection cavity within 14 days of enrollment. The dose of 3x10\^7/m\^2 of TGFβi NK cells (first dose) may be administered at least 14 days after the Ommaya reservoir placement, and may not start until all acute surgical complications have resolved (maximum of 6 weeks after enrollment). TGFβi NK cell infusions through the Ommaya reservoir will occur once weekly for three weeks followed by one rest week. If patients have stable or improved disease, patients may continue to receive therapy for a total of 12 cycles.

If no safety or toxicity events are demonstrated by the previous dose cohort, enrolled patients in the next dosing cohort must proceed to surgery for tumor resection and Ommaya placement into the resection cavity within 14 days of enrollment. The dose of 3x10\^8/m\^2 of TGFβi NK cells (first dose) may be administered at least 14 days after the Ommaya reservoir placement, and may not start until all acute surgical complications have resolved (maximum of 6 weeks after enrollment). TGFβi NK cell infusions through the Ommaya reservoir will occur once weekly for three weeks followed by one rest week. If patients have stable or improved disease, patients may continue to receive therapy for a total of 12 cycles.

The TGFβi NK cell product will be manufactured in the Cell Therapy Laboratory at Nationwide Children's Hospital and given via infusion.

Universal Donor (UD) Transforming growth factor beta imprinting (TGFβi) Natural Killer (NK) Cells

Implantation

Aubrie Dreschler

Aubrie Drechsler

Sabine Mueller, MD, PhD

This phase I trial tests the safety, side effects, and best dose of ex vivo expanded natural killer cells in treating patients with cancerous (malignant) tumors affecting the upper part of the brain (supratentorial) that have come back (recurrent) or that are growing, spreading, or getting worse (progressive). Natural killer (NK) cells are immune cells that recognize and get rid of abnormal cells in the body, including tumor cells and cells infected by viruses. NK cells have been shown to kill different types of cancer, including brain tumors in laboratory settings. Giving NK cells from unrelated donors who are screened for optimal cell qualities and determined to be safe and healthy may be effective in treating supratentorial malignant brain tumors in children and young adults.

PRIMARY OBJECTIVES:

I. To determine the safety and tolerability of natural killer (NK) cells that have been propagated ex vivo with genetically-modified feeder cells and administered intra-tumoral via an Ommaya reservoir in patients with recurrent or progressive supratentorial malignant brain tumors.

II. To determine the recommended phase 2 dose (RP2D) for natural killer (NK) cells that have been propagated ex vivo with genetically-modified feeder cells and administered intra-tumoral via an Ommaya reservoir in patients with recurrent or progressive supratentorial malignant brain tumors.

EXPLORATORY OBJECTIVES:

I. To determine the 6 months overall survival (OS), defined as the percentage of patients in the study who are alive at 6 months following start of treatment.

II. To determine the persistence, immuno-phenotype and function of adoptively-transferred expanded NK cells, and correlate the findings with the overall response.

III. To determine the immune signature-based profile of each patient's tumor. IV. To determine changes in the T-cell receptor (TCR) repertoire diversity before and after Transforming growth factor beta imprinted (TGFβi) NK cell treatment.

V. To evaluate the effect of systemic steroids on the persistence and efficacy of TGFβi NK cells.

VI. To assess Quality of Life (QOL) and cognitive measures in children and young adults with recurrent or progressive supratentorial malignant brain tumors.

OUTLINE: This is a dose-escalation study.

Participants undergo placement of an Ommaya reservoir and receive universal donor expanded TGF-beta-imprinted NK cells (TGFBi NK cells) intratumorally via Ommaya reservoir in 4-week cycles. Infusions via Ommaya will occur once weekly for three weeks followed by one week of rest. If patients have stable or improved disease, patients may continue to receive therapy for a total of 12 cycles. Participants will be followed for 5 years after completion of treatment, or until removal from study or death, whichever comes first.

Intra-Tumoral Injections of Natural Killer Cells for Recurrent Malignant Brain Tumors

A Phase I Study of Intra-Tumoral Injections of Ex Vivo Expanded Natural Killer Cells in Children and Young Adults With Recurrent or Progressive Supratentorial Malignant Brain Tumors

Individual participant data after de-identification.

Adverse events and clinically significant laboratory abnormalities (meeting grade 3, 4, or 5 criteria according to NCI CTCAE) will be summarized by maximum intensity and relationship to study drug(s). Grade 1 and 2 adverse events will be summarized if related to study therapy. Descriptive statistics will be utilized to display the data on toxicity seen. Toxicities will be summarized by tabulation in terms of type, grade and attribution for each dose level of each group of patients studied at the end of the trial.

RP2D is defined as the dose level at which fewer than one-third of participants experience a dose limiting toxicity (DLT)

Rally Foundation

Washington University School of Medicine

Nationwide Children's Hospital

Principal Investigator

Wounds and Injuries

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Neoplasm Metastasis

Fractures, Bone

Pain

Hip Fractures

Pain, Intractable

Neoplasms, Bone Tissue

Bone Neoplasms

Femoral Fractures

Hip Injuries

Leg Injuries

Neurologic Manifestations

Bone Diseases

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Quality of Life

Implantation of Y-Strut + cementoplasty in the femoral neck

Olivier Pellerin, MD, PhD

Carole Dean, PhD

François Cornelis, MD, PhD

Bone metastases appear in many cancers. They are associated with severe pain that is refractory to standard treatment. Improving the quality of life and better pain relief is therefore an essential goal of the treatment of metastatic disease. The most common site of long bone metastases is the superior femoral epiphysis.

The usual management of patients with bone metastases in the superior femoral epiphysis is based on gamma implant osteosynthesis when there is a known risk of fracture (Mirels score\> 8). Nonetheless this surgery is only accessible to a few patients because of the associated morbidities.

Percutaneous cementoplasty has been developed to treat patients who are not eligible for conventional surgery. It consists in a filling of the bone cavity created by metastasis using an acrylic resin. However, these approaches do not completely prevent the risk of upper femoral epiphyseal fracture due to the low mechanical resistance of the resin to shear movements.

The Y-STRUT® implantable medical device was developed to overcome this risk of superior femoral epiphyseal fracture by the biomechanical strengthening of the proximal femur in addition to cementoplasty. It has been successfully tested in more than 70 patients with cancer but access to reimbursement and the APHP market have been postponed due to lack of sufficient clinical evidence.

The investigators propose this prospective phase 2a study in order to provide evidence of the performance of the Y-STRUT® implant.

The design consists in a multicenter national open simple arm trial.

All eligible patients with a lytic bone metastases of the superior femoral epiphysis will be included.

The main objective of this study is to describe the impact of the Y-STRUT® implant on the quality of life of patients with lytic bone metastases of the femoral neck by comparing quality of life scores before and one month after the intervention of implantation of the implant.

Study of the Impact of the Femoral Implant "Y-strut" on Lytic Bone Metastases of the Femoral Neck (WAZA-ARY)

Prospective Multi-center Study of Impact of Femoral "Y-strut" Implant on Pain and Quality of Life in Patients With Lytic Bone Metastases of the Femoral Neck

Measure of the Quality of Life score using the questionary of quality of life of the European Organization for Research and Treatment of Cancer BM-22.

Patients answer at 22 questions to describe their quality of life during the past week. For each question, patient must choose between 1.not at all, 2.a little, 3.enough, 4.a lot. A global score is calculated by adding the 22 score of each questions. The higher value of this global score represents the better outcome.

Number of AE/SAE imputable to the implatation

Consumption of morphinic mean dose per day during the month after the procedure

Consumption of morphinic mean dose per day during the 2 months after the procedure

Use of Visual Analog Scale (VAS) to evaluate the pain at target site (between 0: no pain to 10: intolerable pain)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Investigation of a Transcatheter Tricuspid Valved Stent Graft in Patients With Carcinoid Heart Disease	NCT05064514	Tricuspid Regur... Tricuspid Valve... Carcinoid Syndr... Carcinoid Heart...	Transcatheter T...	18 Years -	Queen Mary University of London
Investigation of a Transcatheter Tricuspid Valved Stent Graft in Patients With Carcinoid Heart Disease	NCT05064514	Tricuspid Regur... Tricuspid Valve... Carcinoid Syndr... Carcinoid Heart...	Transcatheter T...	18 Years -	Queen Mary University of London
Intra-Tumoral Injections of Natural Killer Cells for Recurrent Malignant Brain Tumors	NCT05887882	Pediatric Brain... Recurrent Pedia... Pediatric Supra...	Universal Donor... Implantation	1 Year - 39 Years	University of California, San Francisco
Study of the Impact of the Femoral Implant "Y-strut" on Lytic Bone Metastases of the Femoral Neck (WAZA-ARY)	NCT03887494	Neoplasms, Bone... Pain, Intractab... Hip Fractures	Implantation	18 Years -	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for implantation

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