Mesothelin-Targeted Immunotoxin LMB-100 in People With Malignant Mesothelioma
Status:
Completed
Trial end date:
2021-01-21
Target enrollment:
Participant gender:
Summary
Background:
LMB-100 is a man-made protein. It is attracted to the mesothelin protein. This is found in
many tumors, including mesothelioma. But it is found in only a very small number of normal
tissues. After binding to mesothelin on tumors, LMB-100 attacks and kills cancer cells.
Researchers want to test LMB-100 in people with advanced mesothelioma.
Objective:
To find a safe dose and anti-tumor activity of LMB-100 for people with advanced mesothelioma.
Eligibility:
Adults ages 18 and older with:
Advanced pleural or peritoneal mesothelioma that has not responded to platinum-based
therapy
Adequate organ function
Design:
Participants will be screened with:
Samples of tumor tissue or tumor fluid. These can be new or from a previous procedure.
Medical history
Physical exam
Blood, urine, and heart tests
Chest x-rays
CT or MRI scans
FDG-PET scans
Participants will get LMB-100 on days 1, 3, and 5 of each 21-day cycle. It will be given
through an IV catheter, a tube inserted in an arm vein. They will get standard medicines
before each infusion to help prevent side effects. Each infusion lasts about 30 minutes. They
will be monitored for up to 2 hours after.
During each cycle, participants will repeat the screening tests.
Participants will get the study drug for up to 4 cycles or until their disease worsens or
they have intolerable side effects.
About 4 6 weeks after their last infusion, participants will have a follow-up visit. They
will repeat the study tests.
Participants will have follow-up scans every 6 weeks until their disease gets worse.
Participants will be called about once a year to see how they are doing.
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