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Chemoembolization for Lung Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04200417
Recruitment Status : Recruiting
First Posted : December 16, 2019
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Lung Metastases Endobronchial Metastases Pleural Metastases Mediastinal Metastases Procedure: Chemoembolization Drug: Mitomycin C Drug: Lipiodol Drug: Embospheres Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Transarterial Chemoembolization of Lung Metastases
Actual Study Start Date : December 13, 2019
Estimated Primary Completion Date : December 13, 2021
Estimated Study Completion Date : December 13, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
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.

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.

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




Primary Outcome Measures :
  1. Participant toxicity will be evaluated according to CTCAE v5.0 [ Time Frame: Up to 12 months post treatment ]
    Safety will be evaluated by participant toxicity according to CTCAE v5.0



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04200417


Contacts
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Contact: F. Edward Boas, MD, PhD 212-639-2536 boasf@mskcc.org
Contact: Stephen Solomon, MD 212-639-5012 solomons@mskcc.org

Locations
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United States, New Jersey
Memoral Sloan Kettering Monmouth (Consent only) Recruiting
Middletown, New Jersey, United States, 07748
Contact: F. Edward Boas, MD, PhD    212-639-2536      
United States, New York
Memorial Sloan Kettering Cancer Center @ Commack (Consent Only) Recruiting
Commack, New York, United States, 11725
Contact: F. Edward Boas, MD, PhD    212-639-2536      
Memoral Sloan Kettering Westchester (Consent only) Recruiting
Harrison, New York, United States, 10604
Contact: F. Edward Boas, MD, PhD    212-639-2536      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: F. Edward Boas, MD, PhD    212-639-2536      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: F. Edward Boas, MD, PhD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04200417    
Other Study ID Numbers: 19-371
First Posted: December 16, 2019    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Unresectable Lung Cancer
Unresectable Endobronchial Mestastases
Unresectable Pleural Metastases
Unresectable Mediastinal Metastases
Lung Chemoembolization
19-371
Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Neoplasms
Pathologic Processes
Mitomycins
Mitomycin
Ethiodized Oil
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors