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Immunotoxin
LMB-100 for Mesothelioma
Phase 1
Waitlist Available
Led By David S Schrump, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed mesothelin-positive malignancy arising from or metastatic to the pleura potentially amenable to cytoreductive surgery (R0-R2) and subsequent intrapleural perfusion based on standard of care (SOC) imaging
Participants with biphasic MPM must have a < 50% sarcomatoid component
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at initial perfusion, every 3 months (+/- 2 weeks), to time of documented clinical recurrence and/or death
Awards & highlights
Study Summary
This trial is testing the safety of a drug called LMB-100 given to people who have had surgery to remove pleural tumors.
Who is the study for?
Adults diagnosed with pleural mesothelioma or related cancers that have spread to the lining of the lungs, who haven't had prior local/systemic therapy for MPM, can join. They must be in good health otherwise, with proper lung and organ function, no active brain metastases or serious infections, not pregnant or breastfeeding (or willing to stop), and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing LMB-100's safety after surgery in preventing cancer recurrence in the chest. Participants will undergo cytoreductive surgery followed by a 90-minute intrapleural perfusion of LMB-100. Their recovery will be monitored in intensive care before discharge and they'll have follow-up visits for two years.See study design
What are the potential side effects?
Specific side effects of LMB-100 are not listed but may include typical reactions to immunotoxins such as allergic responses, fever, nausea, liver enzyme changes. Surgery and anesthesia risks include bleeding, infection, pain at incision site and complications from being under anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have a specific type of cancer in the lining of the lungs that might be treatable with surgery and a standard type of treatment.
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If you have biphasic MPM, the sarcomatoid component should be less than half of the tumor.
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If you have stage IV cancer in the lining of your lungs with fluid buildup, you must have already received the standard treatment for your cancer.
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You are over 18 years old.
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You are able to carry out most of your usual activities without needing help.
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You need to have good lung function, as shown by specific breathing tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at initial perfusion, every 3 months (+/- 2 weeks), to time of documented clinical recurrence and/or death
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at initial perfusion, every 3 months (+/- 2 weeks), to time of documented clinical recurrence and/or death
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Identify maximum tolerated dose (MTD) and evaluate the toxicities of LMB-100 administered by 90-minute normothermic, intrapleural perfusion in participants with mesothelin-positive MPM, or MPE from cancers that express mesothelin
Secondary outcome measures
Determine 2 year progression free survival (PFS), and 3 year overall survival of participants following intrapleural LMB-100 perfusion
Identify pharmacokinetics of LMB-100 administered by 90-minute normothermic, intrapleural perfusion
Side effects data
From 2021 Phase 1 & 2 trial • 40 Patients • NCT0281041850%
Proteinuria
33%
Platelet count decreased
33%
Vomiting
33%
Weight gain
17%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, pancreatic cancer
17%
Pleural effusion
17%
Skin and subcutaneous tissue disorders - Other, buttock excoriation
17%
Sinus tachycardia
17%
Wheezing
17%
Right ventricular dysfunction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in 10
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1,Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
Trial Design
2Treatment groups
Experimental Treatment
Group I: 2/ Dose ExpansionExperimental Treatment3 Interventions
LMB-100 at the MTD + MSLN testing
Group II: 1/ Dose EscalationExperimental Treatment3 Interventions
LMB-100 at escalating/de-escalating doses + MSLN testing
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytoreductive surgery
2013
Completed Phase 3
~180
LMB-100
2019
Completed Phase 2
~80
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,667 Total Patients Enrolled
David S Schrump, M.D.Principal InvestigatorNational Cancer Institute (NCI)
18 Previous Clinical Trials
2,224 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a specific type of cancer in the lining of the lungs that might be treatable with surgery and a standard type of treatment.You need to have good lung function, as shown by specific breathing tests.You do not have any active cancer that has spread to your brain. If you had brain cancer in the past, you may still be eligible for the study if it has been treated and there is no sign of active disease.If you have hepatitis B, you must be taking antiviral medication and have a low level of HBV DNA in your blood.You currently smoke cigarettes.You have been taking high-dose steroids for more than a week before starting the treatment.You have received certain types of cancer treatment within three weeks before starting the study, with some minor procedures being exceptions.You have had allergic reactions to similar chemicals or biological substances as LMB-100 or SS1P.You currently have COVID-19.If you have biphasic MPM, the sarcomatoid component should be less than half of the tumor.You may still be eligible if the fluid around your lungs is caused by disease in another part of your body, as long as it is under control and not as serious as the fluid around your lungs.You need to have tumor samples available for testing, or be willing to have a biopsy done to confirm the type of cancer and check for mesothelin expression.You have HIV, but your medication is working well and keeping the virus under control.You have another type of cancer that is getting worse or needs treatment.You had an organ or stem cell transplant that required medication to suppress your immune system.You have an ongoing infection that needs medication to treat.You are over 18 years old.You are able to carry out most of your usual activities without needing help.If you have stage IV cancer in the lining of your lungs with fluid buildup, you must have already received the standard treatment for your cancer.Any side effects from past treatments must be mostly resolved, except for slight anemia, hair loss, or mild nerve problems.You have had a stroke or heart attack within the last 6 months, serious heart problems, or significant blood clots.You have had a lung condition called pneumonitis, unless a lung doctor says it's okay for you to join the study.Your blood counts, kidney function, liver function, and thyroid levels need to be within certain ranges for you to be eligible.Your oxygen level is at least 90% on regular air, or your carbon dioxide level is below 45 and your oxygen level is at least 60 on a blood gas test.
Research Study Groups:
This trial has the following groups:- Group 1: 1/ Dose Escalation
- Group 2: 2/ Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide me with information on the availability of slots for this clinical trial?
"As evidenced by the clinicaltrials.gov database, this study is no longer enrolling patients; it was initially published on December 5th 2022 and had its last update November 29th 2022. Nevertheless, there are still 2617 other medical trials actively searching for participants to partake in their studies."
Answered by AI
Has the Food and Drug Administration certified LMB-100 for public use?
"Due to the limited data on efficacy and safety, our team has concluded that LMB-100 is only at a level 1 of safety."
Answered by AI
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