search
Back to results

Chemoembolization for Lung Tumors

Primary Purpose

Lung Metastases, Endobronchial Metastases, Pleural Metastases

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Chemoembolization
Mitomycin C
Lipiodol
Embospheres
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Metastases focused on measuring Unresectable Lung Cancer, Unresectable Endobronchial Mestastases, Unresectable Pleural Metastases, Unresectable Mediastinal Metastases, Lung Chemoembolization, 19-371, Memorial Sloan Kettering Cancer Center

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memoral Sloan Kettering Monmouth (Consent only)
  • Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)
  • Memoral Sloan Kettering Westchester (Consent only)
  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lung, Endobronchial, Mediastinal or Pleural Metastases

Arm Description

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

Outcomes

Primary Outcome Measures

Participant toxicity will be evaluated according to CTCAE v5.0
Safety will be evaluated by participant toxicity according to CTCAE v5.0

Secondary Outcome Measures

Full Information

First Posted
December 13, 2019
Last Updated
April 21, 2022
Sponsor
Memorial Sloan Kettering Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04200417
Brief Title
Chemoembolization for Lung Tumors
Official Title
Phase I Study of Transarterial Chemoembolization of Lung Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 13, 2019 (Actual)
Primary Completion Date
April 19, 2022 (Actual)
Study Completion Date
April 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Metastases, Endobronchial Metastases, Pleural Metastases, Mediastinal Metastases
Keywords
Unresectable Lung Cancer, Unresectable Endobronchial Mestastases, Unresectable Pleural Metastases, Unresectable Mediastinal Metastases, Lung Chemoembolization, 19-371, Memorial Sloan Kettering Cancer Center

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lung, Endobronchial, Mediastinal or Pleural Metastases
Arm Type
Experimental
Arm Description
Participants will have unresectable and unablatable lung, endobronchial, mediastinal, or pleural metastases (from any primary) that are not responding to chemotherapy
Intervention Type
Procedure
Intervention Name(s)
Chemoembolization
Intervention Description
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
Drug
Intervention Name(s)
Mitomycin C
Intervention Description
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
Intervention Name(s)
Lipiodol
Intervention Description
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
Intervention Name(s)
Embospheres
Intervention Description
Embospheres are non-resorbable spherical microspheres (trisacryl gelatin) that are FDA-approved for embolization of hypervascular tumors.
Primary Outcome Measure Information:
Title
Participant toxicity will be evaluated according to CTCAE v5.0
Description
Safety will be evaluated by participant toxicity according to CTCAE v5.0
Time Frame
Up to 12 months post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Solomon, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memoral Sloan Kettering Monmouth (Consent only)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memoral Sloan Kettering Westchester (Consent only)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

Chemoembolization for Lung Tumors

We'll reach out to this number within 24 hrs