Chemoembolization for Lung Tumors

Lung Metastases Clinical Trial

Official title:

Phase I Study of Transarterial Chemoembolization of Lung Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04200417
• Other study ID #: 19-371
• Status: Completed
• Phase: Phase 1
• Start date: December 13, 2019
• Est. completion date: April 19, 2022

Study information

• Verified date: April 2022
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 19, 2022
• Est. primary completion date: April 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endobronchial Metastases
• Lung Metastases
• Mediastinal Metastases
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Pleural Metastases

Intervention

Procedure:
• 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.

Drug:
• 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.
• Lipiodol
Mitomycin (5mg/m^2,maximum mitomycin dose 20 mg) will be dissolved in lipiodol at 2 mg/ml on the day of procedure.
• Embospheres
Embospheres are non-resorbable spherical microspheres (trisacryl gelatin) that are FDA-approved for embolization of hypervascular tumors.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)	Commack	New York
United States	Memoral Sloan Kettering Westchester (Consent only)	Harrison	New York
United States	Memoral Sloan Kettering Monmouth (Consent only)	Middletown	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant toxicity will be evaluated according to CTCAE v5.0	Safety will be evaluated by participant toxicity according to CTCAE v5.0	Up to 12 months post treatment

External Links

•   Memorial Sloan Kettering Cancer Center