Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Recurrence

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Patients in this arm will each be receiving 3 implanted real-time position transponder beacons (Calypso beacons)

The anchored lung tracking beacons are passive electromagnetic transponder beacons which are placed immediately adjacent to a lung tumor using a bronchoscope. Three beacons will be placed in the small airways of the lung adjacent to the target tumor (within 3 cm of the tumor). Each beacon measures 2 mm in diameter and 8 mm in length and consists of a miniature electrical circuit that is encapsulated in a biocompatible glass capsule. Each beacon has an affixed five-legged anchoring system which expands to 5mm diameter once deployed. The Calypso transponder beacon is placed endobronchially using the working channel of a bronchoscope. Navigational bronchoscopy can be used to pre-plan the optimal location for each beacon to be placed within the airways by using a pre-bronchoscopy CT scan.

Real-Time Position Transponder Beacons

This is a single arm seamless phase I/II prospective cohort study. Patients with early stage Non-Small Cell Lung Cancer (T1-T2N0M0) or those with a single pulmonary metastasis of a known malignancy (either following radical treatment or systemic therapy) will be offered participation in this study. Participants will have three tumor locator beacons placed with a flexible bronchoscope in the small bronchial airways in proximity (\<3cm) from their lung tumors. These tumor locator beacons will provide real-time positional data and will allow for smaller treatment volumes of Stereotactic Ablative Radiosurgery (SABR) and also allow for a specialized form of treatment delivery known as respiratory gated SABR. This is expected to result in higher precision radiotheapy delivery with less radiotherapy dose to healthy tissues which are in close proximity to the lung tumours.

This trial is a seamless phase I/II prospective, single arm, cohort study.

Phase I of the trial will consist of two patients and will serve to conduct quality assurance assessments and to familiarize thoracic surgeons, radiation oncologists, and medical physicists at CancerCare Manitoba and Health Sciences Center in the use and work flow of the Health Canada approved endobronchial implanted real-time tumor tracking transponder beacons. Patients in phase I will undergo standard stereotactic ablative radiotherapy (SABR) of a lung tumor with prior endobronchial transponder beacon placement. For phase I, the transponder beacons will be used for comparative localization analyses and SABR treatment setup procedures will be carried out independent of transponder beacon data, however, transponder data will be collected in order to conduct, post-treatment, in vivo quality assurance assessments of beacon performance characteristics. Otherwise, the SABR treatment for phase I will consist of the currently accepted standard internal target volume based and standard image guided SABR.

Phase II of this trial will consist of 26 patients who will undergo a specialized form of SABR radiotherapy specifically designed to take full advantage of the real-time tumor tracking ability of the transponder beacons. Specifically, SABR in phase II will consist of smaller radiotherapy treatment volumes employing respiratory gating and smaller planning target volume expansion margins given the superior tumor location telemetry afforded by the beacons. Comparative dosimetric analyses contrasting the traditional ITV/PTV style treatments to those with reduced ITV/PTV margins achieved via Calypso guided SABR will be performed. Patient self-reported quality of life and toxicity assessments will be collected with the goal of facilitating power and sample size calculations for the design of a larger phase III randomized controlled trial of Calypso guided SABR treatment in the future

Calypso Guided High Precision Stereotactic Ablative Radiosurgery for Lung TUmours Using Real-Time Tumour Tracking & Respiratory Gating

Calypso Guided High Precision Stereotactic Ablative Radiosurgery for Lung Tumors Using Real-Time Tumor Tracking & Respiratory Gating: A Seamless Phase I/II Prospective Clinical Trial

Mean within patient difference in PTV volumes of standard non-gated SABR treatment compared to PTV volumes of gated SABR using Calypso based PTV margins

Common Terminology Criteria for Adverse Events (CTCAE version 4.0)

Mean within patient difference in radiotherapy doses to thoracic Organs at risk

Local Control (RECIST version 1.1 criteria)

Varian Medical Systems

CancerCare Manitoba

Assistant Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Small Cell Lung Carcinoma

Endometrial Neoplasms

Disease Attributes

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Carboplatin

Pemetrexed

Pembrolizumab

Docetaxel

Ipilimumab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

RGX-104 in combination docetaxel

RGX104 120 mg BID (5day on/2days off)

RGX104 + pembrolizumab + carboplatin/pemetrexed

RGX104 120 mg BID (5day on/2days off)

RGX-104 + docetaxel

RGX104 120 mg BID (5day on/2days off)

RGX-104 combined with ipilimumab

RGX104 120 mg BID (5day on/2days off)

RGX-104

Steve Kaesshaefer

Stacey Kimbell

Sudhir Manda, MD

Monica Mita, MD

Cole Sprague

Erin Schenk, MD

Annie Carpenter

Allen Cohn, MD

Joshua Gordon, MD

Gerald Falchook, MD

Tanya Holoman

Alexander Philipovskiy, MD

Shikila Calder

Pratibha Desai, MD

Christa Baxter

Rebecca Redman, MD

Amanda Woolery

Nicole Perry

Daniel Johnson, MD

Ana Quinones

John Wallmark, MD

Shannon McGinty

Kurt Demel, MD

Ashley Burns

Sean Hobson, MD

Paulina Holly

Demmie Aguilar

Eugenia Girda, MD

Reena Vattakalam

June Hou, MD

Study Coordinator

Adbul Naqash, MD

Tracey Newhall

Rita Axelrod, MD

Anna Lesnik

Angela Jain, MD

Lilliana Payne

Alexander Spira, MD

Robert Wasserman, MD

Study RGX-104-001 is a Phase 1, first-in-human, dose escalation and expansion study of RGX-104, an oral small molecule targeting the liver X receptor (LXR), as a single agent and in combination with nivolumab, ipilimumab, docetaxel, or pembrolizumab plus carboplatin/pemetrexed.

RGX-104 activates LXR, resulting in depletion of both myeloid-derived suppressor cells (MDSCs) as well as tumor blood vessels. MDSCs block the ability of T-cells and other cells of the immune system from attacking tumors.

During the dose escalation stage, multiple doses and schedules of orally administered RGX-104 with or without nivolumab, ipilimumab, docetaxel, or pembrolizumab plus carboplatin/pemetrexed (single agent or combination therapy) will be evaluated in patients with advanced solid tumors and lymphoma (i.e., locally advanced and unresectable, or metastatic) who have had progressive disease (PD) on available standard systemic therapies or for which there are no standard systemic therapies of relevant impact. Dose escalation in combination with pembrolizumab plus carboplatin/pemetrexed will be restricted to patients with non-small cell lung cancer (NSCLC).

In the expansion stage of the study, additional patients with endometrial cancer, epithelial ovarian carcinoma (EOC), NSCLC, or small cell lung cancer (SCLC)/high-grade neuroendocrine tumors (HG-NET) will be treated at the MTD (or maximum tested dose if no MTD is identified, or dose below the MTD if there is evidence suggesting a more favorable risk/benefit profile). This stage will provide further characterization of the safety, efficacy, PK, and pharmacodynamics, including biomarkers of immunologic activity and LXR target activation, of RGX-104 as a single agent (EOC), in combination with docetaxel (SCLC/HG-NET), and and in combination with pembrolizumab plus carboplatin/pemetrexed (NSCLC).

A Study of RGX-104 in Patients With Advanced Lung & Endometrial Cancer

A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, as a Single Agent and as Combination Therapy in Patients With Advanced Solid Malignancies and Expansion in Select Malignancies

Inspirna, Inc.

Nutritional and Metabolic Diseases

Behaviors and Mental Disorders

Malnutrition

Quality of Life

The oncology care team will provide participants with nutrition toolkit involving printed educational materials, a nutrition prescription, referral to registered dietitians (RDs) for remotely-delivered medical nutrition therapy counseling, and home-delivery of medically tailored meals.

The oncology care team will provide participants with a nutrition toolkit involving printed educational materials.

Medical oncology providers will refer participants to oncology RDs for remotely delivered medical nutrition therapy counseling. For cohort 1, participants will receive nutrition counseling for 8 months. The counseling will be provided on a weekly basis during the first 6 months and every other week during the last 2 months (for cohort 1 only). For cohort 2, participants will receive nutrition counseling for 6 months. The ultimate frequency of nutrition counseling being provided to each participant will also be adjusted according to the participant's preference and needs.

Nutritional Counseling

Medically tailored meals will be provided to participants in the intervention group for a total of 24 weeks for both cohorts. During the first 8 weeks of the intervention, 3 meals/day will be provided each week for a total of 168 meals per participant. It will be followed by less frequent meal provision during the subsequent 16 weeks following this schedule: 3 meals/day will be provided every other week for the next 8 weeks (a total of 84 meals per participant); and 3 meals/day will be provided every four weeks during the last 8 weeks (a total of 42 meals per participant). The number of meals provided to each participant may be adjusted according to participant's preference and needs.

Medically Tailored Meals (MTMs)

Oncology providers will advise participants with lung cancer to follow evidence-based nutrition recommendations using a Nutrition Prescription. The Nutrition Prescription aims to enhance providers' role in communicating basic nutrition advice to participants with lung cancer. It contains seven recommendations, adapted from the newly released Cancer Prevention Recommendations by WCRF/AICR with strong evidence-base.

Nutrition Prescription

Oncology care providers will assess the nutritional status of patients with lung cancer using PG-SGA Short Form (the Scored Patient-Generated Subjective Global Assessment). PG-SGA is an interdisciplinary patient assessment in oncology and other chronic catabolic conditions. The short form contains four patient generated historical components (weight history, food intake symptoms, and activities and function).

Nutrition Assessment

Patients will receive a printed copy of a Nutrition Toolkit from providers. Evidence-based nutrition recommendations have been compiled for cancer survivors from 4 sources into a Nutrition Toolkit. The sources include: (1) AmericanCancer Society (ACS) Nutrition and Physical Activity Guidelines for Cancer Survivors; (2)World Cancer Research Fund / American Institute for Cancer Research (WFRF/AICR) Cancer Nutrition Guide; (3) National Cancer Institute (NCI) Eating Hints; and (4) National Comprehensive Cancer Network (NCCN) Guidelines for Cancer Survivors. The Nutrition Toolkit outlines topics about the impact of cancer treatment on dietary intake patterns and quality, strategies to manage treatment-related eating issues, maintaining a healthy weight post treatment, and evidence-based recommendations and practical. Nutrition Toolkit strategies for improving diet quality and maintaining an optimal weight for cancer survivors.

Nutrition Toolkit

Monthly emails will be sent to participants to encourage the use of the toolkit with healthy recipes and general nutrition information.

Monthly Emails

FangFang Zhang, MD, PhD

Colleen Spees, PhD, MEd, RD, LD, FAND

The NutriCare study aims to develop, implement, and evaluate the efficacy of an innovative intervention strategy (medically tailored meals plus nutrition counseling) to integrate nutrition into the standard of care for oncology to improve outcomes of vulnerable patients with lung cancer. The NutriCare study evaluates the efficacy of the intervention on optimizing nutritional status, reducing treatment-related toxicities, and improving the quality of life of patients with lung cancer who are economically disadvantaged, uninsured, racial and ethnic minorities, elderly, and/or rural residents from four major medical centers in diverse regions of the United States (U.S.). There will be two cohorts for NutriCare with cohort 1 recruiting 150 patients completing an 8-month intervention and cohort 2 recruiting 120 patients completing a 6-month intervention.

For the proposed study, we will randomize participants into two groups at a 1:1 ratio to an intervention or an enhanced control group. For participants randomized to the enhanced control group, the NutriTool, the oncology care team will provide participants with a nutrition toolkit involving printed educational materials. For participants randomized to the intervention group, the NutriCare, the oncology care team will additionally provide participants with home-delivery of medically tailored meals and referral to registered dietitians (RDs) for remotely-delivered nutrition counseling.

NutriCare Plus a Medically Tailored Meal Intervention Among Patients With Lung Cancer

NutriCare Intervention on Optimizing Nutritional Status, Reducing Treatment-Related Toxicities, and Improving Quality of Life Among Vulnerable Patients With Lung Cancer

(a) participation; (b) retention; (c) compliance

Change in diet quality and intake of key food groups and nutrients as assessed by the National Cancer Institute Diet History Questionnaire (DHQ III)

Change in weight and percent weight loss as measured in the clinic

Change in food insecurity measured by the U.S. Department of Agriculture (USDA) Household Food Security Survey

Change in patient-reported symptoms (fatigue, pain, nausea, vomiting, appetite loss, and sleep disturbance) as assessed by a Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE)

Change in patient-reported functional outcomes (physical, social, and cognitive functioning) assessed by GAD-7

Change in patient-reported functional outcomes (physical, social, and cognitive functioning) assessed by PHQ-9

Change in quality of life as assessed by EORTC-QLQ-30

Change in quality of life as assessed by EORTC-QLQ-LC13

Rate of hospitalizations will assessed by medical record review and linkage with discharge data

Rate of ED visits assessed by medical record review and linkage with discharge data

Rate of treatment-related toxicities assessed by the treating medical oncologist using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE)

Treatment completion (dose reductions and treatment delays) assessed by the treating medical oncologist

Change in gut microbiome via metagenomic whole shotgun sequencing (mWGS)

National Death Index search performed approximately 5 years after the final patient is enrolled.

Fox Chase Cancer Center

M.D. Anderson Cancer Center

Ohio State University

Tufts Medical Center

Tufts University

Associate Professor, The Neely Family Professor and Associate Professor

Neoplastic Cells, Circulating

Neoplasm Metastasis

Neoplastic Processes

Chia-Hsun Hsieh, MD

Yi-Cheng Wu, MD

Cheng-Ta Yang, MD

JUI-YING Fu, MD

ChingFeng Wu, MD

From literature review, circulating tumor cell was demonstrated its possible role in disease relapse. It was rare nit could be identified in all lung cancer patients. In addition, circulating tumor cell usual aggregate to form circulating tumor micro-emboli and caused distant metastases. Therefore, circulating tumor cell could play a role in detect disease relapse and appropriate treatment could be given more earlier and further prolong patients' survival. However, the detail clinical significance of circulating tumor still remains unknown. The aim of this study was evaluate the clinical significance, including present timing, numbers, and correlation to disease relapse, of circulating tumor cell in lung cancer patients. The investigators want to clarify the clinical significance between circulating tumor cell and clinical presentation of lung cancer in order to establish new prediction model and improve lung cancer patients' survival.

Study subject:

Inclusion criteria 1. Patients with clinical stage 1 to 3a non-small lung cancer 2. Patients with a resectable suspicious pulmonary lesion which is difficult for pre-operation tissue prove or refused for pre-operation biopsy 3. Received curative intended tumor resection Exclusion criteria

1. Small cell lung cancer component which identified in pathology
2. Patients who presented as stage IIIb or IV
3. Not received curative intended surgery due to multi-comorbidities
4. Patients who presented in tumor seeding or positive resection in pathology confirmation
5. Patients who received neoadjuvant therapy

Data collection:

medical record review and blood sampling for circulating tumor cell purification

Timing of blood sampling:

a.Pre-operation, post-operation, post-operation day 1, post-operation day 3 b regular OPD surveillance (3 month-interval) for 3 years

Blood sampling: 20 ml blood that withdrawn from a peripheral vein

Circulating tumor cell purification: two-step procedure

1. cell isolation: centrifugation, isolated karyocyte \> 10 micrometer
2. negative selection: wash out RBC, WBC depletion
3. positive selection: purify circulating tumor cell (karyocyte which presented CD 45 negative, Epi-CAM positive, diameter greater 10 micrometer

Result analysis:

Combine the medical record to analyze the relationship between circulating tumor cells and disease relapse

Recurrent Predictive Power of Circulating Tumor Cells for Non Small Cell Lung Cancer Patients

Recurrent Predictive Power of Circulating Tumor Cells in Non Small Cell Lung Cancer Patients Who Receive Curative Resection

Relationship between variation trend of circulating tumor cells and disease relapse in patients with a suspicious pulmonary lesion after tumor resection

sequence patient recruitment for validation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Calypso Guided High Precision Stereotactic Ablative Radiosurgery for Lung TUmours Using Real-Time Tumour Tracking & Respiratory Gating	NCT03322072	Lung Cancer Sta... Lung Cancer Sta... Lung Cancer, No... Lung Cancer Rec... Lung Cancer Sta...	Real-Time Posit...	18 Years - 85 Years	CancerCare Manitoba
Calypso Guided High Precision Stereotactic Ablative Radiosurgery for Lung TUmours Using Real-Time Tumour Tracking & Respiratory Gating	NCT03322072	Lung Cancer Sta... Lung Cancer Sta... Lung Cancer, No... Lung Cancer Rec... Lung Cancer Sta...	Real-Time Posit...	18 Years - 85 Years	CancerCare Manitoba
A Study of RGX-104 in Patients With Advanced Lung & Endometrial Cancer	NCT02922764	Endometrial Can... Endometrial Can... Lung Cancer Rec... Lung Cancer Non-small Cell ... Non-small Cell ...	RGX-104 Ipilimumab Docetaxel Pembrolizumab Carboplatin Pemetrexed	18 Years -	Inspirna, Inc.
NutriCare Plus a Medically Tailored Meal Intervention Among Patients With Lung Cancer	NCT04986670	Lung Cancer, Sm... Lung Cancer Met... Lung Cancer Rec... Treatment Side ... Lung Cancer, No... Nutritional Imb...	Nutritional Cou... Medically Tailo... Nutrition Presc... Nutrition Asses... Nutrition Toolk... Monthly Emails	18 Years - 100 Years	Tufts University
Recurrent Predictive Power of Circulating Tumor Cells for Non Small Cell Lung Cancer Patients	NCT03721133	Lung Cancer Rec...		18 Years - 90 Years	Chang Gung Memorial Hospital
Recurrent Predictive Power of Circulating Tumor Cells for Non Small Cell Lung Cancer Patients	NCT03721133	Lung Cancer Rec...		18 Years - 90 Years	Chang Gung Memorial Hospital

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