Chemoembolization for Lung Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-13

Study Completion Date

2022-04-19

Brief Summary

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This study is being done to determine if it is safe to perform lung chemoembolization and if the lung chemoembolization procedure can successfully deliver chemotherapy to lung tumors.

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Detailed Description

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Conditions

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Lung Metastases Endobronchial Metastases Pleural Metastases Mediastinal Metastases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lung, Endobronchial, Mediastinal or Pleural Metastases

Participants will have unresectable and unablatable lung, endobronchial, mediastinal, or pleural metastases (from any primary) that are not responding to chemotherapy

Group Type EXPERIMENTAL

Chemoembolization

Intervention Type PROCEDURE

Chemoembolization will be performed via the artery (bronchial, non-bronchial systemic, or pulmonary) that shows the greatest tumor enhancement on angiography. Chemoembolization will be performed using a lipiodol / mitomycin emulsion, followed by spherical particles.

Mitomycin C

Intervention Type DRUG

Mitomycin (5mg/m\^2,maximum mitomycin dose 20 mg) will be dissolved in lipiodol at 2 mg/ml on the day of procedure.

Lipiodol

Intervention Type DRUG

Mitomycin (5mg/m\^2,maximum mitomycin dose 20 mg) will be dissolved in lipiodol at 2 mg/ml on the day of procedure.

Embospheres

Intervention Type DRUG

Embospheres are non-resorbable spherical microspheres (trisacryl gelatin) that are FDA-approved for embolization of hypervascular tumors.

Interventions

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Chemoembolization

Chemoembolization will be performed via the artery (bronchial, non-bronchial systemic, or pulmonary) that shows the greatest tumor enhancement on angiography. Chemoembolization will be performed using a lipiodol / mitomycin emulsion, followed by spherical particles.

Intervention Type PROCEDURE

Mitomycin C

Mitomycin (5mg/m\^2,maximum mitomycin dose 20 mg) will be dissolved in lipiodol at 2 mg/ml on the day of procedure.

Intervention Type DRUG

Lipiodol

Mitomycin (5mg/m\^2,maximum mitomycin dose 20 mg) will be dissolved in lipiodol at 2 mg/ml on the day of procedure.

Intervention Type DRUG

Embospheres

Embospheres are non-resorbable spherical microspheres (trisacryl gelatin) that are FDA-approved for embolization of hypervascular tumors.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Lung, endobronchial, pleural, or mediastinal metastases that are not responding to systemic chemotherapy, and that are not amenable to ablation, resection, or SBRT.
* At least 18 years old.
* ECOG performance status 0 or 1

Exclusion Criteria

* Primary lung cancer
* \>50% of a lung is replaced with tumor
* Oxygen saturation \<92% on room air
* FEV1 \<60%
* Pulmonary hypertension (diagnosed or suspected on echocardiography, CT, MRI, or direct pressure measurement)
* Recent pulmonary embolism (within 3 months)
* Pulmonary arteriovenous malformation
* Active lung infection (pneumonia, empyema, or lung abscess requiring therapy within 1 month)
* Symptomatic heart failure (dyspnea, volume overload)
* Left bundle branch block (contraindication to pulmonary angiography)
* Renal failure (eGFR \<30 mL/min/1.73m\^2)
* Pregnancy
* Breastfeeding
* Altered mental status that would interfere with consent or follow-up
* Platelets \< 100,000 (after transfusion, if needed)
* INR\>2 (after transfusion, if needed)
* Hemoglobin \<7 (after transfusion, if needed)
* Hyperthyroidism (contraindication to lipiodol)
* Planned radioactive iodine imaging or therapy (contraindication to lipiodol)
* Allergy to lipiodol or mitomycin
* Allergy to iodinated contrast that can not be treated with steroid / diphenhydramine premedication
* Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No