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Platinum-based Chemotherapy
Chemotherapy + Immunotherapy for Mesothelioma
Phase 2
Recruiting
Led By Aaron S Mansfield
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
Age >= 18 years
No prior systemic therapy for peritoneal mesothelioma is allowed. No concurrent radiotherapy is allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study entry to the first of either disease progression or death from any cause, where disease progression will be determined based on response evaluation criteria in solid tumors (recist) 1.1 criteria, assessed up to 3 years
Awards & highlights
Study Summary
This trial is testing immunotherapy (atezolizumab) in addition to the usual treatment of surgery or chemotherapy in patients with peritoneal mesothelioma.
Who is the study for?
Adults with untreated malignant peritoneal mesothelioma, without a history of central nervous system disease, significant bleeding disorders, or severe heart conditions. They must have functioning major organs and no autoimmune diseases (with some exceptions like controlled thyroid issues). Women must not be pregnant or nursing and agree to use birth control.Check my eligibility
What is being tested?
The trial is testing the effectiveness of adding immunotherapy (atezolizumab) to the usual treatment for peritoneal mesothelioma which includes surgery and chemotherapy drugs like carboplatin and pemetrexed. The goal is to see if atezolizumab helps the immune system fight cancer better than standard treatments alone.See study design
What are the potential side effects?
Potential side effects include allergic reactions to medication, increased risk of infection due to immune system suppression, bleeding complications, high blood pressure from bevacizumab, liver function changes, fatigue, nausea from chemotherapy drugs, and possible organ inflammation from atezolizumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have not had any treatment for peritoneal mesothelioma.
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I haven't had major blood vessel problems like aneurysms or clots in the last 6 months.
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I have untreated malignant peritoneal mesothelioma, not the well-differentiated or multicystic type.
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I have not had a transplant of stem cells or any organs from another person.
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I haven't had major heart issues or strokes in the past year.
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I am not on IV antibiotics for an infection.
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I do not have any serious wounds, ulcers, or untreated bone fractures.
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I haven't had any major stomach or intestine issues in the last 6 months.
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I don't have a history of bleeding disorders.
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I haven't coughed up a noticeable amount of blood recently.
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My brain metastases were treated and I'm on a low dose of steroids.
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I am fully active or can carry out light work.
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I have never had lung scarring or inflammation not caused by infections.
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I have never had a hypertensive crisis or brain issues due to high blood pressure.
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My kidney function is sufficient, with a creatinine clearance rate of at least 45 mL/min.
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I have never had a severe blood clot.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from study entry to the first of either disease progression or death from any cause, where disease progression will be determined based on response evaluation criteria in solid tumors (recist) 1.1 criteria, assessed up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study entry to the first of either disease progression or death from any cause, where disease progression will be determined based on response evaluation criteria in solid tumors (recist) 1.1 criteria, assessed up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rate
Secondary outcome measures
Completeness of cytoreduction
Conversion rate to surgical resection among those not deemed to be surgical candidates
Incidence of adverse events
+3 moreOther outcome measures
Megakaryocytes
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (carboplatin, pemetrexed, bevacizumab, atezolizumab)Experimental Treatment9 Interventions
Patients receive atezolizumab IV over 60 minutes, bevacizumab IV over 30-90 minutes, carboplatin IV over 30 minutes, and pemetrexed IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 4-8 weeks, patients undergo cytoreductive surgery and HIPEC. Patients not eligible for surgery may receive atezolizumab and bevacizumab in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and PET scan on study. Patients also undergo blood and tissue sample collection on study.
Group II: Arm II (carboplatin, pemetrexed, bevacizumab)Active Control8 Interventions
Patients receive bevacizumab IV over 30-90 minutes, carboplatin IV over 30 minutes, and pemetrexed IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 4-8 weeks, patients undergo cytoreductive surgery and HIPEC. Patients not eligible for surgery may receive bevacizumab with or without atezolizumab at the discretion of the investigator in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and PET scan on study. Patients also undergo blood and tissue sample collection on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
2014
Completed Phase 3
~5250
Positron Emission Tomography
2008
Completed Phase 2
~2240
Hyperthermic Intraperitoneal Chemotherapy
2010
Completed Phase 3
~210
Biospecimen Collection
2004
Completed Phase 2
~1730
Bevacizumab
2013
Completed Phase 4
~5280
Carboplatin
2014
Completed Phase 3
~6670
Computed Tomography
2017
Completed Phase 2
~2720
Cytoreductive Surgery
2011
Completed Phase 1
~150
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,658 Previous Clinical Trials
40,924,421 Total Patients Enrolled
Aaron S MansfieldPrincipal InvestigatorAlliance for Clinical Trials in Oncology
3 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your AST and ALT levels should not be more than three times the upper limit of normal.Your disease must be able to be measured using specific guidelines.I haven't had a biopsy or minor surgery, except for a device placement, in the last 7 days.I am not pregnant or nursing and, if capable of bearing children, have a recent negative pregnancy test.I am 18 years old or older.I have not had any treatment for peritoneal mesothelioma.I haven't had major blood vessel problems like aneurysms or clots in the last 6 months.I have untreated malignant peritoneal mesothelioma, not the well-differentiated or multicystic type.You have a low level of white blood cells.I have not had a transplant of stem cells or any organs from another person.I haven't had major heart issues or strokes in the past year.I am not on IV antibiotics for an infection.I do not have any serious wounds, ulcers, or untreated bone fractures.I haven't taken strong immune system medications in the last 2 weeks.I haven't had any major stomach or intestine issues in the last 6 months.I have no untreated brain disorders unrelated to my cancer.Your absolute neutrophil count is 1,500 or higher.I don't have an active or history of serious autoimmune diseases, but controlled thyroid issues, Type 1 diabetes, or mild skin conditions are okay.I agree to use effective birth control during the study due to the risk of birth defects.Your high blood pressure is not well controlled (systolic blood pressure above 150 and/or diastolic blood pressure above 100).I don't have a history of bleeding disorders.I haven't coughed up a noticeable amount of blood recently.My brain metastases were treated and I'm on a low dose of steroids.I do not have any uncontrolled conditions like infection, diabetes, or heart disease.I am fully active or can carry out light work.I have no active cancer except for non-dangerous skin cancer or treated cervical cancer.My hepatitis B is under control with treatment.I had hepatitis C but am cured, or I'm being treated with no detectable virus.Your bilirubin levels should be within a certain range.I must avoid NSAIDs around my pemetrexed treatment due to my kidney function.Your platelet count is at least 100,000 per cubic millimeter.I have never had lung scarring or inflammation not caused by infections.I have never had a hypertensive crisis or brain issues due to high blood pressure.I haven't had major surgery or serious injury in the last 28 days.The ratio of protein to creatinine in your urine is less than 1, or the amount of protein in your urine is equal to or less than 1+.I am HIV positive, on treatment, and my viral load is undetectable.I may have had a live vaccine recently, but I got my flu and COVID-19 shots.I haven't had any cancer except skin cancer in the last 5 years.My vascular access device was placed at least 2 days before starting the study treatment.My kidney function is sufficient, with a creatinine clearance rate of at least 45 mL/min.I have never had a severe blood clot.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (carboplatin, pemetrexed, bevacizumab)
- Group 2: Arm I (carboplatin, pemetrexed, bevacizumab, atezolizumab)
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.
What adverse reactions have been associated with Pemetrexed?
"The safety profile of pemetrexed is estimated to be at a 2 due to the results from Phase 2 trials, which demonstrated some security but no proof that it was effective."
Answered by AI
Is this investigation of medical treatments open to volunteers?
"This medical trial is currently enrolling participants, as seen on clinicaltrials.gov. It was originally posted October 15th 2021 and the details were most recently updated August 24th 2022."
Answered by AI
What is the maximum capacity for participants within this research?
"To execute this clinical trial, 66 participants who fulfill the necessary requirements need to be enrolled. These individuals have the option of two medical centres - Sanford USD Medical Center in Sioux Falls or Fairview Southdale Hospital in Edina - from which they can receive treatment."
Answered by AI
What maladies has the drug Pemetrexed been proven to mitigate?
"Pemetrexed is the go-to treatment for advanced endometrial cancer, but it has also been proven effective at managing melanoma, recurrent platinum-sensitive epithelial ovarian cancer, and metastatic ureter urothelial carcinoma."
Answered by AI
In which venues can this research be accessed?
"The trial is enrolling patients at 24 different sites, such as Sanford USD Medical Center - Sioux Falls in South dakota, Fairview Southdale Hospital in Minnesota and Unity Hospital located near Fridley."
Answered by AI
Are there any precedent investigations utilizing Pemetrexed?
"In 2002, Pemetrexed was first investigated at H Central de Asturias. Since then, 1977 trials have been concluded and 1284 remain ongoing - with a significant concentration of them occurring in Sioux Falls, South dakota."
Answered by AI
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