Chemoembolization for Lung Tumors
Phase 1
Completed
- Conditions
- Lung MetastasesPleural MetastasesMediastinal MetastasesEndobronchial Metastases
- Interventions
- Registration Number
- NCT04200417
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lung, Endobronchial, Mediastinal or Pleural Metastases Chemoembolization Participants will have unresectable and unablatable lung, endobronchial, mediastinal, or pleural metastases (from any primary) that are not responding to chemotherapy Lung, Endobronchial, Mediastinal or Pleural Metastases Mitomycin C Participants will have unresectable and unablatable lung, endobronchial, mediastinal, or pleural metastases (from any primary) that are not responding to chemotherapy Lung, Endobronchial, Mediastinal or Pleural Metastases Embospheres Participants will have unresectable and unablatable lung, endobronchial, mediastinal, or pleural metastases (from any primary) that are not responding to chemotherapy Lung, Endobronchial, Mediastinal or Pleural Metastases Lipiodol Participants will have unresectable and unablatable lung, endobronchial, mediastinal, or pleural metastases (from any primary) that are not responding to chemotherapy
- Primary Outcome Measures
Name Time Method Participant toxicity will be evaluated according to CTCAE v5.0 Up to 12 months post treatment Safety will be evaluated by participant toxicity according to CTCAE v5.0
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Memoral Sloan Kettering Monmouth (Consent only)
🇺🇸Middletown, New Jersey, 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
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States