Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Malignant Mesothelioma

Patients who have been diagnosed with metastatic mesothelioma

No intervention

Sabine Hazan, MD

Jordan Daniels, MS

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Metastatic Mesothelioma

A Pilot Study to Explore the Role of Gut Flora in Metastatic Mesothelioma

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Metastatic Mesothelioma

Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized with metastatic mesothelioma

ProgenaBiome

Digestive System Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Colorectal Neoplasms

Cholangiocarcinoma

Breast Neoplasms

Adenocarcinoma

Triple Negative Breast Neoplasms

Pancreatic Neoplasms

Carcinoma, Non-Small-Cell Lung

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Cystadenocarcinoma, Serous

Cystadenocarcinoma

Breast Diseases

Skin Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Carcinoma

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Neoplasms, Cystic, Mucinous, and Serous

Pancreatic Cancer

Ovarian Cancer

Bile Duct Cancer

Ovarian Epithelial Cancer

Adenocarcinoma of the Appendix

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Lymphodepletion (fludarabine and cyclophosphamide) followed by TC-510 T cells

TC-510

TC-510 is a novel cell therapy that consists of autologous genetically engineered T cells expressing two synthetic constructs: first, a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex and second, a PD-1:CD28 switch receptor, which is expressed on the surface of the T cell, independently from the TCR. The PD-1:CD28 switch receptor comprises the PD-1 extracellular domain fused to the CD28 intracellular domain via a transmembrane domain. Thus, the switch is designed to produce a costimulatory signal upon engagement with PD-L1 on cancer cells.

A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer

A Phase 1/2 Single Arm Open-Label Clinical Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer

Phase 1 -The number and percent of patients in the DLT evaluable set who experienced DLTs from the first administration of study drug up to 28 days post study drug treatment will be summarized by dosing group

ORR is defined as incidence of complete responses or partial responses as assessed by RECIST v1.1

DCR defined as a composite of ORR and stable disease (SD) lasting at least 8 weeks.

TCR2 Therapeutics

Behaviors and Mental Disorders

Anxiety Disorders

Pseudomyxoma Peritonei

Peritoneal Neoplasms

Abdominal Neoplasms

Peritoneal Diseases

Adenocarcinoma, Mucinous

Herbal and Botanical

Cola

An initiation session to cardiac coherence will take place D-11 before the operation (during the surgical consultation) in order to obtain a breathing rate of 6 cycles/min via a free application (Respirelax) with listening to an audio tape.

3 cardiac coherence sessions per day of 5 min (before meals) during the 11 days preceding the operation.

- The program cardiac coherence will be performed during 90 days after the surgery

Cardiac coherence

Standard care

Jean-Pierre BLEUSE, MD

Jean-Pierre Bleuse, MD

Estelle Guerdoux, PhD

Estelle Guerdoux-Ninot, MD

The investigator proposes to use the cardiac coherence technique to diminish anxiety before the surgery of a peritoneal carcinosis of colon or stomach or ovary and pseudomyxoma or peritoneal mesothelioma.

Facing a Peritoneal Carcinomatosis (PC) diagnosis requires significant psychological adjustments that may generate major distress because of heavy care and a sometimes poor prognosis. Psychological distress, which most frequently results in emotional anxiety and depressive disorders, affects nearly 40% of patients in oncology. These disorders impair their quality of life, their health behaviours, their therapeutic alliance with caregivers, and represent a risk factor for mortality since access to care, lifestyle and therapeutic adherence differ. All learned societies (e.g., American Society of Clinical Oncology - ASCO), associations (e.g., Union for International Cancer Control (UICC), World Cancer Research Fund International - WCRF) and authorities (e.g., French National Institute of Cancer) recommend both the screening and treatment of this psychological distress. This complementary therapy should be integrated in the overall management of cancer patients, especially since anxiolytics (e.g., benzodiazepines) have shown limitations in clinical trials compared with placebo or standard care. Studies evaluating relevant psychological interventions to treat these disorders are rare. It is therefore essential to assess the feasibility and relevance of implementing a non-drug intervention known for its anxiolytic and antidepressant effects, to respond early and appropriately to the distress and anxiety of patients with PC before and after their surgery. Among the various existing non-drug interventions, a targeted cardiac coherence program seems promising. Cardiac coherence corresponds to a physiological state of balance of the autonomic nervous system obtained through precise and rigorous breathing exercises. Several pilot studies justify its interest in oncology. The main objective of this study is to evaluate adherence to a cardiac coherence program aimed at reducing anxiety in patients with PC awaiting cytoreductive surgery. The secondary objectives are to evaluate the implementation of this program in a cancer center, its adoption by the patients and the impact of this practice on their anxious symptomatology, immunological response and quality of life.

Impact of Cardiac Coherence on Anxiety in Patients Operated on for a Peritoneal Carcinosis

Implementation of a Cardiac Coherence Program to Reduce Anxiety in Patients With Peritoneal Carcinosis Treated by Surgery: Randomized Pilot Study

All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all disidentified participants' data, the study protocol, the statistical analysis plan and analytic code. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.

Cardiac Coherence Program Adherence Rate. Patients are considered in "success" adhere to the program) if they will perform at least 20 of the 30 sessions scheduled until surgery (minimum 1 practice per day).

This scale measures the anxiety of patient. It's a visual analogue scale which is also known as linear analogue scale. These scales require respondents to place a mark on a line on which opposing statements or descriptions are placed at either end of a (usually) 10 cm line. The points at which respondents make their mark represent where they perceive their answer to lie in this continuum. The distance between their mark and one end (or the mid-point) of the scale is recorded. The position on the left being the absence of anxiety and the position on the right an unbearable anxiety.

One subscale for evaluation of anxiety from 0 (lower anxiety) to 21 (higher anxiety) and the other subscale for depression from 0 (lower anxiety) to 21 (higher depression)

This scale measures the psychological distress of the patient . Psychological distress is characterized by the presence of symptoms, most often depressive or anxious.It's a visual analogue scale which is also known as linear analogue scale. These scales require respondents to place a mark on a line on which opposing statements or descriptions are placed at either end of a line. The position of the mark on the top is the higher psychological distress and at the bottom the lower psychological distress.

The scale is used to identify people with generalized anxiety disorder compared to people with other anxiety disorders or people without pathologies. Range is from 27 (lower uncertainty) to 135 (higher uncertainty)

The heart rate variability is determined by using the software EmWave Pro which measures the ratio low frequencies/high frequencies.

The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.

The EORTC QLQ-C30 uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.

This scale measures the pain of patient. It's a visual analogue scale which is also known as linear analogue scale. These scales require respondents to place a mark on a line on which opposing statements or descriptions are placed at either end of a (usually) 10 cm line. The points at which respondents make their mark represent where they perceive their answer to lie in this continuum. The distance between their mark and one end (or the mid-point) of the scale is recorded. The position on the left being the absence of pain and the position on the right an unbearable pain.

State anxiety reflects the current emotional state, which allows the patient's nervousness and worry to be assessed during the session. The range is from 20 (lower anxiety) to 80 (higher anxiety). The patient must answer 20 questions for each part, each answer being on a 4 point Likert scale.

Trait anxiety reflects the usual emotional state. The range is from 20 (lower anxiety) to 80 (higher anxiety).The patient must answer 20 questions for each part, each answer being on a 4 point Likert scale

Score including psychological, physiological and biological variables

Institut du Cancer de Montpellier - Val d'Aurelle

Symptoms and General Pathology

Recurrence

Carcinoma, Bronchogenic

Bronchial Neoplasms

Nivolumab

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel

fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel with nivolumab 360mg every 3 weeks starting on Day 21 post gavo-cel

fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel with nivolumab 360mg every 3 weeks starting on Day 21 post gavo-cel and ipilimumab 1mg/kg every 6 weeks starting on Day 42 post gavo-cel

gavo-cel

fludarabine

cyclophosphamide

Gavocabtagene autoleucel (gavo-cel; TC-210) is a novel cell therapy that consists of autologous genetically engineered T cells expressing a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex.

This Phase 1/2 study aims to establish the recommended Phase 2 dose (RP2D) and subsequently evaluate the efficacy of gavo-cel, with and without immuno-oncology agents, in patients with advanced mesothelin-expressing cancers, with overall response rate and disease control rate as the primary Phase 2 endpoints.

Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer

A Phase 1/2 Single Arm Open-Label Clinical Trial of Gavocabtagene Autoleucel (Gavo-cel) in Patients With Advanced Mesothelin-Expressing Cancer

Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events.

To evaluate the efficacy of autologous genetically modified T cells (gavo-cel), with or without immuno-oncology agents, in patients with MSLN-expressing unresectable, metastatic, or recurrent cancers as determined by overall response rate and disease control rate using RECIST v1.1 (or mesothelioma-specific RECIST criteria, if applicable).

Bristol-Myers Squibb

Adenocarcinoma of Lung

Fallopian Tube Neoplasms

Fallopian Tube Diseases

Fallopian Tube Cancer

Lung Adenocarcinoma

Single dose of 1-3x10\^7 huCARTmeso cells/m\^2

Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to a single dose of 1-3x10\^7 huCARTmeso cells/m\^2

Single dose of 1-3x10\^7 huCART-meso cells/m\^2 day 0 by intrapleural infusion (IP) through an indwelling pleural catheter without any conditioning chemotherapeutic regimen.

Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to dose of 1-3x10\^7 huCART-meso cells/m\^2 via IV infusion on Day 0. This initial infusion may be followed by up to two additional IV infusions of huCART-meso cells at the same dose level, given approximately 21-42 days apart, if the subject meets eligibility to receive additional infusions. Cyclophosphamide will not be repeated prior to subsequent doses of huCART-meso cells.

Cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day given over 3 days by IV infusion followed by a single dose of 1-3x10\^7 huCART-meso cells/m\^2 via intraperitoneal (i.p.) administration. Lymphodepleting chemotherapy will be scheduled such that the last day of chemotherapy is 3 days (+/- 1 day) prior to the infusion of huCART-meso cells. This initial i.p. infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of huCART-meso cells.

Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..

huCART-meso cells

Janos L Tanyi, MD, PhD

Phase I study to establish safety and feasibility of both intravenous administration and local delivery of lentiviral transduced huCART-meso cells with or without lymphodepletion.

This is a Phase I study evaluating the safety and feasibility of both intravenous administration and local delivery of lentiviral transduced huCART-meso cells with and without lymphodepleting chemotherapy.

* Cohort 1 (N=3-6): will receive a single dose of 1-3x10\^7 huCARTmeso cells/m\^2 on day 0 without any conditioning chemotherapeutic regimen.
* Cohort 2 (N=3-6): will receive a single dose of 1-3x10\^7 huCARTmeso cells/m\^2 on day 0, following a flat dose of 1 gram/m2 of cyclophosphamide administered 2-4 days prior to huCARTmeso cells (day -4 to day -2).
* Cohort 3 (N=3-6): will receive a single dose of 1-3x10\^8 /m\^2 lentiviral transduced huCART-meso cells on day 0 without any conditioning chemotherapeutic regimen. \*\*Cohort 3 permanently closed\*\*
* Cohort 4 subjects (N=3-6) will receive a single dose of 1-3x10\^8 /m\^2 lentiviral transduced huCART-meso cells on day 0, following a flat dose of 1 gram/m\^2 of cyclophosphamide administered 2-4 days prior to huCART-meso cells (day -4 to day -2). \*\*Cohort 4 permanently closed\*\*
* Cohort 5 (N=up to 6): will receive a single dose of 1-3x10\^7 huCARTmeso cells/m\^2 on day 0 by intrapleural infusion (IP) through an indwelling pleural catheter without any conditioning chemotherapeutic regimen. The safety of this dose level has been established by Cohorts 1 and 2.
* Cohort 6 (N=up to 6): will receive a dose of 1-3x10\^7 huCARTmeso cells/m\^2 via IV infusion on Day 0, following a flat dose of 1 gram/m\^2 of cyclophosphamide administered 2-4 days prior to huCART-meso cells (\~Day -4 to -2). This initial infusion may be followed by up to two additional IV infusions of huCART-meso cells at the same dose level, given between 21-42 days apart, if the subject meets eligibility to receive additional infusions. Cyclophosphamide will not be repeated prior to subsequent doses of huCART-meso cells. Enrollment into Cohort 6 will occur in parallel with Cohort 5.
* Cohort 7 (N = up to 6): will receive a single dose of 1-3x10\^7 huCART-meso cells/m\^2 via intraperitoneal (i.p.) administration, following lymphodepleting chemotherapy with cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day given over 3 days by intravenous infusion. Lymphodepleting chemotherapy will be scheduled such that the last day of chemotherapy is 3 days (+/- 1 day) prior to the 1st infusion of huCART-meso cells. This initial i.p. infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of huCART-meso cells.

The Maximum Tolerated Dose (MTD) is defined as the dose at which 0-1 DLT occurs in 6 evaluable subjects tested within the dose range of this study. The maximum tolerated dose has been established as 1-3x10\^7 huCARTmeso cells/m\^2.

Adverse events will be collected and evaluated during the protocol specified adverse event reporting period

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Pilot Study to Explore the Role of Gut Flora in Metastatic Mesothelioma	NCT04214015	Mesothelioma Mesothelioma Ma... Mesothelioma; L... Mesotheliomas P... Mesothelioma Pe... Mesothelioma; L... Mesothelioma; O...	No intervention	-	ProgenaBiome
A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer	NCT05451849	Mesothelioma Mesotheliomas P... Mesothelioma, M... Mesothelioma Pe... Ovarian Cancer Ovarian Serous ... Pancreatic Canc... Pancreatic Aden... Colorectal Canc... Triple Negative... TNBC - Triple-N... Ovarian Adenoca... Pancreatic Neop... Colorectal Neop... Ovarian Neoplas... Cholangiocarcin... Non Small Cell ...	TC-510 Fludarabine Cyclophosphamid...	18 Years -	TCR2 Therapeutics
Impact of Cardiac Coherence on Anxiety in Patients Operated on for a Peritoneal Carcinosis	NCT04024917	Peritoneal Carc... Pseudomyxoma Pe... Mesothelioma Pe...	Cardiac coheren... Standard care	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle
Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer	NCT03907852	Mesothelioma Mesothelioma, M... Mesothelioma; P... Mesotheliomas P... Mesothelioma Pe... Cholangiocarcin... Cholangiocarcin... Ovarian Cancer Non Small Cell ... Non Small Cell ... High Grade Ovar...	gavo-cel fludarabine cyclophosphamid... Nivolumab Ipilimumab	18 Years -	TCR2 Therapeutics
A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer	NCT05451849	Mesothelioma Mesotheliomas P... Mesothelioma, M... Mesothelioma Pe... Ovarian Cancer Ovarian Serous ... Pancreatic Canc... Pancreatic Aden... Colorectal Canc... Triple Negative... TNBC - Triple-N... Ovarian Adenoca... Pancreatic Neop... Colorectal Neop... Ovarian Neoplas... Cholangiocarcin... Non Small Cell ...	TC-510 Fludarabine Cyclophosphamid...	18 Years -	TCR2 Therapeutics
CAR T Cells in Mesothelin Expressing Cancers	NCT03054298	Lung Adenocarci... Ovarian Cancer Peritoneal Carc... Fallopian Tube ... Mesotheliomas P... Mesothelioma Pe...	huCART-meso cel...	18 Years -	University of Pennsylvania

Spots Global Cancer Trial Database for mesothelioma peritoneum