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Transarterial Chemoembolization for the Treatment of Lung Metastases

Trial Status: Active

This phase I trial studies the side effects of transarterial chemoembolization in treating patients with tumors that has spread to the lungs (lung metastases). Lung chemoembolization works by delivering chemotherapy directly into the artery that supplies oxygen to lung tumors. At the same time, the artery is plugged up (embolized). This traps the chemotherapy inside the tumor and also cuts off the tumor’s blood supply. As a result, the tumor is exposed to a high dose of chemotherapy, and is also deprived of nutrients and oxygen.

Inclusion Criteria

  • Lung, endobronchial, pleural, or mediastinal metastases that are not responding to systemic chemotherapy, and that are not amenable to ablation, resection, or stereotactic body radiation therapy (SBRT)
  • Eastern Cooperative Oncology Group (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
  • Forced expiratory volume in 1 second (FEV1) < 60%
  • Pulmonary hypertension (diagnosed or suspected on echocardiography, CT, magnetic resonance imaging [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 (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m^2)
  • Pregnancy
  • Breast-feeding
  • Altered mental status that would interfere with consent or follow-up
  • Platelets < 100,000 (after transfusion, if needed)
  • International normalized ratio (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 cannot 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

New Jersey

Middletown
Memorial Sloan Kettering Monmouth
Status: ACTIVE
Contact: Franz Edward Boas
Phone: 212-639-2536

New York

Commack
Memorial Sloan Kettering Commack
Status: ACTIVE
Contact: Franz Edward Boas
Phone: 212-639-2536
New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Franz Edward Boas
Phone: 212-639-2536
West Harrison
Memorial Sloan Kettering Westchester
Status: ACTIVE
Contact: Franz Edward Boas
Phone: 212-639-2536

PRIMARY OBJECTIVES:

I. Safety of lung chemoembolization.

II. Technical success rate.

SECONDARY OBJECTIVES:

I. Objective response rate (partial or complete response) of treated lesions at 4-6 weeks, among patients who had a technically successful treatment.

II. Percentage of lung metastases supplied by bronchial artery, non-bronchial systemic artery, and pulmonary artery, based on catheter angiography.

III. Agreement between predicted blood supply (bronchial versus pulmonary artery) to lung metastases, based on non-invasive imaging (triphasic lung computed tomography [CT]), and actual blood supply, as determined by catheter angiography.

IV. Fraction of prescribed dose of mitomycin that could be delivered (total mitomycin dose delivered / total prescribed dose).

V. Pharmacokinetics of intra-arterial mitomycin, including: peak concentration (Cmax), volume of distribution, area under curve (AUC), and termination half-life (t 1/2).

VI. Lipiodol retention in tumors, based on Hounsfield units on non-contrast CT obtained immediately and 4-6 weeks post-procedure.

OUTLINE:

Patients receive mitomycin intra-arterially (IA) and lipiodol IA while undergoing transarterial chemoembolization. If the embolization endpoint is not reached, patients may also receive tris-acryl gelatin microspheres IA.

After completion of study treatment, patients are followed up at 1-2 and 4-6 weeks.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Franz Edward Boas

  • Primary ID 19-371
  • Secondary IDs NCI-2019-08714
  • Clinicaltrials.gov ID NCT04200417