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Platinum-based Chemotherapy
Chemotherapy + Immunotherapy for Peritoneal 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
Histologically or cytologically confirmed malignant peritoneal mesothelioma for which there has been no prior treatment. Given the indolent nature of well-differentiated papillary mesothelioma and multicystic mesothelioma, patients with these variants are not eligible for participation
All slides including performed immunostains from diagnostic tumor tissue together with pathology report for retrospective central pathology review
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upfrom 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
No Placebo-Only Group
Study Summary
This trial is testing immunotherapy (atezolizumab) in addition to the usual treatment of surgery or chemotherapy in patients with peritoneal mesothelioma.
Eligible Conditions
- Malignant Mesothelioma
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Bevacizumab
2014
Completed Phase 4
~5320
Positron Emission Tomography
2008
Completed Phase 2
~2240
Cytoreductive Surgery
2011
Completed Phase 1
~150
Pemetrexed
2014
Completed Phase 3
~4270
Computed Tomography
2017
Completed Phase 2
~2890
Hyperthermic Intraperitoneal Chemotherapy
2010
Completed Phase 3
~210
Atezolizumab
2016
Completed Phase 3
~6040
Biospecimen Collection
2004
Completed Phase 1
~1540
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,489 Previous Clinical Trials
41,266,611 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:- You have a mental illness that would make it difficult for you to understand and agree to participate in the study.You have another type of cancer that is currently active, except for non-melanoma skin cancers or cervical carcinoma in situ. If you have completed treatment and have been cancer-free for at least 3 years, you are eligible to participate.
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 cancerg 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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