Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Pleural Effusion, Malignant

Pleural Neoplasms

Pleural Effusion

Pleural Diseases

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Anti-Infective Agents

All Drugs and Chemicals

Doxycycline

Anti-Bacterial Agents

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Patients undergo IPC placement and receive doxycycline via IPC 5 days later.

Indwelling Catheter

Quality-of-Life Assessment

Questionnaire Administration

Survey Administration

David Ost

This study is designed to obtain preliminary data comparing indwelling pleural catheters (IPCs) versus IPCs plus doxycycline for pleurodesis as treatments for malignant pleural effusion (MPE). Indwelling pleural catheters (IPCs) are commonly used to treat pleural effusions (build-up of fluid in the lungs). Doxycycline is an antibiotic that is also used to treat pleural effusions. The goal of this clinical research study is to learn if adding doxycycline to the use of an IPC can lead to shorter treatment times with IPCs.

PRIMARY OBJECTIVES:

I. To obtain preliminary data comparing indwelling pleural catheters (IPCs) versus IPCs plus doxycycline for pleurodesis as treatments for malignant pleural effusion (MPE).

OUTLINE: Patients choose 1 of 2 groups.

GROUP I: Patients undergo IPC placement and receive doxycycline via IPC 5 days later.

GROUP II: Patients undergo IPC placement.

After completion of study treatment, patients are followed up at 10-14 days and then monthly for up to a year.

Indwelling Pleural Catheters With or Without Doxycycline in Treating Patients With Malignant Pleural Effusions

A Prospective Observational Cohort Study of Indwelling Pleural Catheters Versus Indwelling Pleural Catheters Plus Doxycycline Pleurodesis for Treatment of Malignant Pleural Effusions

This outcome will be analyzed by cause-specific hazard Cox model with treatment group as a covariate. Whenever a catheter is removed, the cause for removal will be documented. For the analysis, causes will include removal due to decreased drainage (i.e., as per plan) as well as removal due to complications (e.g. infection, empyema, refractory pain) or other reasons (e.g. catheter plugged but no complication to the patient, patient preference without a complication). We will also analyze time to catheter removal for any cause and conduct pre-specified secondary analyses to evaluate the effect of fluid drainage amount (i.e., how much was being put out from the indwelling pleural catheter (IPC) the day of IPC placement and on the day of doxycycline instillation) and size of residual effusion as assessed by chest x-ray (CXR) (on day of IPC placement and day of doxycycline instillation) on time to catheter removal.

Will use the Kaplan-Meier product-limit method to estimate median quality-adjusted life years (QALYs) following IPC placement.

Will use paired t-test to compare baseline and 1 month Borg scores and utilities. A generalized linear model will be used to evaluate whether other variables have any impact on the pairwise differences between baseline and 1 month.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Mediastinal Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Diseases

Mediastinal Diseases

Thoracic Diseases

Antineoplastic Agents

Chlorotrianisene

Mitomycins

Mitomycin

Ethiodized Oil

Antibiotics, Antitubercular

Alkylating Agents

Enzyme Inhibitors

Patients receive lipiodol intra-arterially (IA), mitomycin IA, and embospheres IA and undergo TACE on study. Patients also undergo angiography and computed tomography (CT) at baseline and follow up.

Computed Tomography

Transarterial Chemoembolization

Tris-acryl Gelatin Microspheres

Franz E. Boas

Franz E Boas

This phase II trial evaluates how well transarterial chemoembolization (TACE) works for treating patients with non-small cell lung cancer. TACE is a minimally invasive procedure that involves injecting chemotherapy directly into an artery that supplies blood to tumors, and then blocking off the blood supply to the tumors. Mitomycin (chemotherapy), Lipiodol (drug carrier), and Embospheres (small plastic beads that block off the artery) are injected into the tumor-feeding artery. This traps the chemotherapy inside the tumor and also cuts off the tumor's blood supply. As a result, the tumor is exposed to a high dose of chemotherapy, and is also deprived of nutrients and oxygen. TACE can be effective at controlling or stopping the growth of lung tumors.

PRIMARY OBJECTIVE:

I. To determine safety and efficacy (local progression free survival) of chemoembolization of lung cancer that is chemorefractory, unresectable, and unablatable.

OUTLINE:

Patients receive lung chemoembolization using Lipiodol, mitomycin, and Embospheres. Response to treatment is evaluated on computed tomography (CT) scans.

Transarterial Chemoembolization for the Treatment of Lung Cancer

Phase II Trial of Lung Chemoembolization

Progression is determined using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. criteria, compared to the scan immediately prior to treatment of that territory, using the 2 largest measurable lesions per treated territory. Local progression-free survival will be estimated using the Kaplan-Meier method.

Complications will be classified using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The rate of complications can be estimated with a standard error of less than 10%. Further, any complication that occurs with a 10% incidence will be observed with greater than 95% probability.

Evaluated on a per-treatment basis, using RECIST version 1.1 criteria.

Will be estimated using the Kaplan-Meier method.

Percentage of treatments where target tumors were supplied by bronchial artery, non-bronchial systemic artery, or pulmonary artery, based on catheter angiography. Confidence intervals of proportions will be estimated using the equal-tailed Jeffreys prior interval.

Correlation between lipiodol retention and change in tumor size will be evaluated using Spearman's rank correlation coefficient (rho) and Spearman's test.

Percentage change in size (largest diameter) of the largest treated, compared to the largest untreated tumor will be evaluated using the Wilcoxon signed-rank test.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Indwelling Pleural Catheters With or Without Doxycycline in Treating Patients With Malignant Pleural Effusions	NCT03465774	Pleural Neoplas...	Doxycycline Indwelling Cath... Quality-of-Life... Questionnaire A... Survey Administ...	18 Years -	M.D. Anderson Cancer Center
Transarterial Chemoembolization for the Treatment of Lung Cancer	NCT05672108	Lung Non-Small ... Mediastinal Neo... Pleural Neoplas...	Computed Tomogr... Ethiodized Oil Mitomycin Transarterial C... Tris-acryl Gela...	18 Years -	City of Hope Medical Center

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