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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lung, Endobronchial, Mediastinal or Pleural Metastases | Experimental | Participants will have unresectable and unablatable lung, endobronchial, mediastinal, or pleural metastases (from any primary) that are not responding to chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemoembolization | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Solomon, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memoral Sloan Kettering Monmouth (Consent only) | Middletown | New Jersey | 07748 | United States | ||
| Memorial Sloan Kettering Cancer Center @ Commack (Consent Only) |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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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| ID | Term |
|---|---|
| D016461 | Chemoembolization, Therapeutic |
| D016685 | Mitomycin |
| D004998 | Ethiodized Oil |
| C496735 | trisacryl gelatin microspheres |
| ID | Term |
|---|---|
| D004621 | Embolization, Therapeutic |
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
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|
| Mitomycin C | 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 | 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 | Drug | Embospheres are non-resorbable spherical microspheres (trisacryl gelatin) that are FDA-approved for embolization of hypervascular tumors. |
|
| Commack |
| New York |
| 11725 |
| United States |
| Memoral Sloan Kettering Westchester (Consent only) | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| D008937 |
| Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007459 | Iodized Oil |
| D010938 | Plant Oils |
| D009821 | Oils |
| D008055 | Lipids |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |