Mesothelin-Targeted Immunotoxin LMB-100 in Combination With SEL-110 in Subjects With Malignant Pleural or Peritoneal Mesothelioma

Stopped early · Phase 1

Conditions studied: Mesothelioma

In brief

Background: Mesothelioma is cancer of the tissue that lines some organs. A new drug, LMB-100, may bind to a protein on mesothelioma tumors and kill cancer cells. But sometimes the body makes antibodies that reduce how well LMB-100 works. Researchers want to see if adding the drug SEL-110 to LMB-100 will prevent these antibodies from forming. Objective: To learn how safe and tolerable LMB-100 plus SEL-110 is in people with advanced mesothelioma. Eligibility: Adults ages 18 and older who have pleural or peritoneal mesothelioma that has not responded to prior platinum-based therapy Design: Participants will be screened with * Medical history * Physical exam * Blood and urine tests * Sample of tumor tissue. This can be from a previous procedure. * Scan of the chest, abdomen, and pelvis. Participants will lie on a table in a scanner that takes pictures. A special dye may be injected in a vein. * Positron emission tomography (fludeoxyglucose positron emission tomography (FDG-PET)) scan. A sugar attached to a chemical that gives off a signal will be injected before the scan. * Heart function tests The study will be done in 21-day cycles. Participants will get the study drugs for up to 4 cycles. They will get them through an intravenous (IV) catheter (a tube inserted in a vein, usually in the arm): * LMB-100 for about 30 minutes on day 1, day 3, and day 5 of each cycle * SEL-110 for about 1 hour on day 1 of each cycle Participants will get standard medicines to help prevent side effects. Participants will repeat some screening tests during each cycle and about 5 weeks after the last dose of study drug.

Key facts

Study ID: NCT03436732
Run by: National Cancer Institute (NCI)
People needed: 5
Starts: 2018-02-28
Expected to finish: 2019-04-30
Last updated by the study team: 2019-11-22

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Known or clinically suspected central nervous system (CNS) primary tumors or metastases including leptomeningeal metastases. History or clinical evidence of CNS metastases unless they have been previously treated, are asymptomatic, and have had no requirement for steroids or enzyme-inducing anticonvulsants in the last 14 days.
Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including significant pulmonary disease other than primary cancer, uncontrolled diabetes mellitus, and/or significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, uncontrolled arrhythmias, unstable angina, non-compensative congestive heart failure, or clinically significant pericardial effusion)
Active or uncontrolled infections.
Human immunodeficiency virus (HIV) or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. HIV positive patients will be excluded due to a theoretical concern that the degree of immune suppression associated with the treatment may result in progression of HIV infection.
Patients with prior pneumonectomy
Prior therapy with LMB-100
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
Major surgery or significant traumatic injury greater than or equal to 28 days prior to the first LMB-100 infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment
Dementia or altered mental status that would prohibit informed consent
Live attenuated vaccinations 14 days prior to treatment
Pregnant women are excluded from this study because it is unknown whether LMB-100 + SEL 100 has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with LMB-100+SEL-110, breastfeeding should be discontinued if the mother is treated with LMB-100+SEL-110. These potential risks may also apply to other agents used in this study.
Known hypersensitivity to any of the components of LMB-100 and/or SEL-110
Presence of immunosuppressive conditions, including administration of any medications or treatments that may adversely affect the immune system such as allergy injections, immune globulin, interferon, immunomodulators, cytotoxic drugs, or systemic corticosteroids (oral or injectable) during 3 months prior to enrollment.
Inhaled and topical corticosteroids allowed.
Known allergy to polyethylene glycol (PEG)ylated products.
History of anaphylactic reaction to a recombinant protein or hypersensitivity to PEG.
Taken an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study.
Taken a strong inhibitor or inducer of cytochrome P450 3A4 (CYP3A4) within 14 days prior to enrollment (see Flockhart Table or similarly updated source for a list of such agents)
Taken drugs known to interact with Rapamune such as cyclosporine, diltiazem, erythromycin, ketoconazole (and other antifungals), nicardipine (and other calcium channel blockers), rifampin, verapamil within 14 days prior to enrollment
Uncontrolled hypertension (above 150/95 mm Hg).
History of end-stage renal disease requiring dialysis.
Serum phosphorus less than 2.0 mg/dL
Organ transplant recipient

Where it is running

National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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