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Atezolizumab, Pemetrexed Disodium, Cisplatin, and Surgery with or without Radiation Therapy in Treating Patients with Stage I-III Pleural Malignant Mesothelioma

Trial Status: Closed to Accrual

This phase I pilot trial studies how well atezolizumab, pemetrexed disodium, cisplatin, and surgery with or without radiation therapy works in treating patients with stage I-III pleural malignant mesothelioma. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving atezolizumab, pemetrexed disodium, and cisplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving atezolizumab after surgery may kill any remaining tumor cells.

Inclusion Criteria

  • STEP 1: NEOADJUVANT
  • Patient must have stage I-III malignant pleural mesothelioma that is deemed resectable and must be planning to undergo pleurectomy decortication (P/D) or extrapleural pneumonectomy (EPP)
  • Patient must have epithelioid or biphasic histology (sarcomatoid histology is excluded); histologic diagnosis and typing of mesothelioma requires at least a core needle biopsy or surgical biopsy of the pleura via thoracoscopy and small thoracotomy; cytology only will not be regarded as sufficient for the diagnosis
  • Patient must have computed tomography (CT) chest/abdomen/pelvis with contrast or fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/CT scan performed within 28 days prior to step 1 registration
  • Patients must have non-measurable or measurable disease documented by CT or magnetic resonance imaging (MRI); the CT from a combined PET/CT may be used to document only non-measurable disease unless it is of diagnostic quality; measurable disease must be assessed within 28 days prior to step 1 registration; non-measurable disease must be assessed within 42 days prior to step 1 registration; all disease must be assessed and documented on the RECIST 1.1 and modified RECIST baseline tumor assessment form
  • Patient must have undergone extended surgical staging including mediastinoscopy or endobronchial ultrasound; at minimum, samples must be obtained from the mediastinal stations 4R, 7 (subcarinal), and 4L; this surgical staging must be performed within 42 days prior to step 1 registration; patient must be T1-3 and N0-N2 (single station)
  • Patient must undergo video-assisted thoracoscopic surgery and diagnostic laparoscopy within 28 days prior to step 1 registration to rule out peritoneal disease spread
  • Patient must have consultation with a surgeon within 21 days prior to step 1 registration; the surgeon must confirm that the patient’s disease is resectable by pleurectomy decortication (P/D) or extrapleural pneumonectomy (EPP) and that the patient is an appropriate candidate for the surgical procedures
  • Patient must not have had prior immunotherapy or chemotherapy for malignant pleural mesothelioma
  • Patient must have Zubrod performance status 0 or 1 documented within 28 days prior to step 1 registration
  • Patients requiring hearing aids or reporting hearing loss must have audiogram performed within 28 days prior to step 1 registration
  • Patient must have not had any major surgery or radiation within 28 days prior to step 1 registration; diagnostic thoracotomies and laparoscopies are not considered major surgeries
  • Patients must not have any anticancer therapy or investigational agent within 28 days prior to step 1 registration
  • Absolute neutrophil count (ANC) >= 1,500/mcl (documented within 28 days prior to step 1 registration)
  • Hemoglobin >= 9 g/dl (documented within 28 days prior to step 1 registration)
  • Platelets >= 100,000/mcl (documented within 28 days prior to step 1 registration)
  • Creatinine =< 1.5 x upper limit of normal (ULN) (documented within 28 days prior to step 1 registration)
  • Creatinine clearance >= 45 ml/min (documented within 28 days prior to step 1 registration)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) (within 28 days prior to step 1 registration)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (within 28 days prior to step 1 registration)
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years
  • Patients must not be pregnant or nursing due to the potential teratogenic side effects of the protocol treatment; women of reproductive potential and men must have agreed to use an effective contraceptive method for the duration of study treatment and for 5 months (150 days) after the last dose of atezolizumab; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • Patient must NOT have a history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Patient must NOT have a known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
  • Patients must not have severe infections within 28 days prior to step 1 registration, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Patients must not have active autoimmune disease that has required systemic treatment in past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment; autoimmune diseases include, but are not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis; this protocol includes an immunotherapy agent which can precipitate known autoimmune diseases
  • Patients must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation
  • Patient must not have active tuberculosis
  • Patient must not have history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis; this protocol includes an immunotherapy agent which can precipitate known pneumonitis
  • Patient must not have active (chronic or acute) hepatitis B virus (HBV) infection as evidenced by testing performed within 28 days prior to registration; patients with past or resolved HBV infection are eligible; active HBV is defined as having a positive hepatitis B surface antigen (HBsAg) test; past or resolved HBV is defined as having a negative HBsAG test and a positive total hepatitis B core antibody (HBcAb) test; patient must not have active hepatitis C virus (HCV) infection as evidenced by testing performed within 28 days prior to registration; active HCV is defined as having a positive HCV antibody test followed by a positive HCV RNA test
  • Patient must NOT have a known positive test for human immunodeficiency virus (HIV); patients do not need to be screened for HIV; patients with HIV are excluded due to a potential incompetent immune system and need for medications that could interfere with the treatment and immunotherapy
  • Patient must not have significant cardiovascular disease, such as New York Heart Association cardiac disease (class II or greater), myocardial infarction within 3 months prior to initiation of treatment, unstable arrhythmias, or unstable angina given the higher risks associated with surgical resection
  • Patient must not receive live, attenuated influenza vaccine within 4 weeks prior to registration or at any time during the study and until 5 months after the last dose of atezolizumab
  • Patient must be willing to have tissue specimens submitted for translational medicine studies
  • Patient must be offered the opportunity to participate in tissue and blood banking for future studies
  • Patient must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • As a part of the Oncology Patient Enrollment Network (OPEN) registration process, the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  • STEP 2: SURGERY
  • Patient must have a CT of chest/abdomen with contrast or FDG-PET/CT scan within 28 days prior to step 2 registration; patients must not have evidence of progression per RECIST 1.1 or modified RECIST for pleural tumors
  • Patients planning to receive EPP must also be evaluated for appropriateness of radiation therapy (RT) by a radiation oncologist within 14 days prior to step 2 registration
  • Patients must have a Zubrod performance status of 0-1 documented within 28 days prior to step 2 registration
  • Patients must have postoperative predicted forced expiratory volume in 1 second (FEV1) > 35% prior to surgery obtained within 28 days prior to step 2 registration; pulmonary function tests to ascertain these values must be obtained within 28 days prior to Step 2 registration
  • Patients must have postoperative predicted carbon monoxide diffusing capability (DLCO) > 35% prior to surgery obtained within 28 days prior to step 2 registration; pulmonary function tests to ascertain these values must be obtained within 28 days prior to Step 2 registration
  • Patient must have received at least two cycles of triplet neoadjuvant therapy (all three drugs) during step 1
  • Patient must be registered to step 2 no less than 21 days and no more than 90 days after the end of their final cycle of neoadjuvant therapy
  • STEP 3: MAINTENANCE
  • Patient must have received either P/D or EPP and must have recovered from all effects of surgery with adequate wound healing; patients who received radiation therapy (RT) must be registered to step 3 within 90 days after discontinuing RT; patients who did not receive RT must be registered to step 3 within 90 days after surgery
  • Patient must have a CT of chest/abdomen/pelvis with contrast or FDG-PET/CT scan within 28 days prior to step 3 registration; patient must not have evidence of progression per RECIST 1.1 or modified RECIST for pleural tumors
  • Patient may have discontinued RT early due to toxicity or other reasons
  • Patients must have a Zubrod performance status of 0-1 documented within 28 days prior to step 3 registration
  • ANC > 1,500/mcl (documented within 28 days prior to step 3 registration)
  • Hemoglobin > 9 g/dl (documented within 28 days prior to step 3 registration)
  • Platelets > 100,000/mcl (documented within 28 days prior to step 3 registration)
  • Creatinine < 1.5 x ULN (documented within 28 days prior to step 3 registration)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) (within 28 days prior to step 3 registration)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (within 28 days prior to step 3 registration)

Arizona

Phoenix
Mayo Clinic Hospital in Arizona
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 855-776-0015
Scottsdale
Mayo Clinic in Arizona
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 855-776-0015

Arkansas

Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518

California

Arroyo Grande
PCR Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Duarte
City of Hope Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-826-4673
Sacramento
University of California Davis Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 916-734-3089

Colorado

Colorado Springs
Penrose-Saint Francis Healthcare
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Rocky Mountain Cancer Centers-Penrose
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Denver
Porter Adventist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Durango
Mercy Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Southwest Oncology PC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Golden
Mountain Blue Cancer Care Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Lakewood
Rocky Mountain Cancer Centers-Lakewood
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Saint Anthony Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Littleton
Littleton Adventist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Longmont
Longmont United Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Rocky Mountain Cancer Centers-Longmont
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Parker
Parker Adventist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Rocky Mountain Cancer Centers-Parker
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Pueblo
Rocky Mountain Cancer Centers - Pueblo
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Saint Mary Corwin Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Thornton
Rocky Mountain Cancer Centers-Thornton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518

Florida

Jacksonville
Baptist MD Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 904-202-7468

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Coeur D'Alene
Kootenai Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Meridian
Idaho Urologic Institute-Meridian
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Nampa
Saint Alphonsus Medical Center-Nampa
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Post Falls
Kootenai Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Sandpoint
Kootenai Cancer Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060

Illinois

Aurora
Rush - Copley Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 630-978-6212
Bloomington
Illinois CancerCare-Bloomington
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Canton
Illinois CancerCare-Canton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Carbondale
Memorial Hospital of Carbondale
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 618-457-5200
Carterville
SIH Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 618-985-3333
Carthage
Illinois CancerCare-Carthage
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Centralia
Centralia Oncology Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4740
Danville
Carle on Vermilion
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4740
Decatur Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4740
Effingham
Carle Physician Group-Effingham
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Crossroads Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4740
Eureka
Illinois CancerCare-Eureka
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Galesburg
Illinois CancerCare-Galesburg
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Western Illinois Cancer Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-344-2831
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Macomb
Illinois CancerCare-Macomb
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
O'Fallon
Cancer Care Center of O'Fallon
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4762
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Pekin
Illinois CancerCare-Pekin
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Peoria
Illinois CancerCare-Peoria
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Methodist Medical Center of Illinois
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
OSF Saint Francis Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Peru
Illinois CancerCare-Peru
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Valley Radiation Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 815-664-4141
Princeton
Illinois CancerCare-Princeton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Springfield
Memorial Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-788-3528
Southern Illinois University School of Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-545-7929
Springfield Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-444-7541
Swansea
Southwest Illinois Health Services LLP
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 618-236-1000
Urbana
Carle Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
The Carle Foundation Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Yorkville
Rush-Copley Healthcare Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 630-978-6212

Iowa

Ames
Mary Greeley Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-956-4132
McFarland Clinic PC - Ames
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-239-4734
Boone
McFarland Clinic PC-Boone
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-956-4132
Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Mercy Cancer Center-West Lakes
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Council Bluffs
Alegent Health Mercy Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Creston
Greater Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Des Moines
Medical Oncology and Hematology Associates-Laurel
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Mercy Medical Center - Des Moines
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-956-4132
Jefferson
McFarland Clinic PC-Jefferson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-956-4132
Marshalltown
McFarland Clinic PC-Marshalltown
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-956-4132
West Des Moines
Mercy Medical Center-West Lakes
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518

Kansas

Lawrence
Lawrence Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Wichita
Ascension Via Christi Hospitals Wichita
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-362-0070
Cancer Center of Kansas - Wichita
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Cancer Center of Kansas-Wichita Medical Arts Tower
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374

Kentucky

Bardstown
Flaget Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Corbin
Commonwealth Cancer Center-Corbin
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Lexington
Saint Joseph Hospital East
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Saint Joseph Radiation Oncology Resource Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
London
Saint Joseph London
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Louisville
Jewish Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Jewish Hospital Medical Center Northeast
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Saints Mary and Elizabeth Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Shepherdsville
Jewish Hospital Medical Center South
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518

Louisiana

New Orleans
Ochsner Medical Center Jefferson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 504-703-8712

Michigan

Brownstown
Henry Ford Cancer Institute-Downriver
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-916-3721
Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-916-3721
Detroit
Henry Ford Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-916-3721
Jackson
Allegiance Health
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-916-3721
Shelby Township
Henry Ford Macomb Health Center - Shelby Township
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-916-1784
West Bloomfield
Henry Ford West Bloomfield Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-916-3721

Minnesota

Rochester
Mayo Clinic in Rochester
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 855-776-0015

Missouri

Bonne Terre
Parkland Health Center-Bonne Terre
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-996-5569
Cape Girardeau
Saint Francis Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Southeast Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-651-5550
Jefferson City
Capital Region Southwest Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-632-4814
Saint Louis
Missouri Baptist Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-996-5569
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-996-5569
Sullivan
Missouri Baptist Sullivan Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-996-5569
Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-996-5569

Montana

Anaconda
Community Hospital of Anaconda
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Billings
Billings Clinic Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-996-2663
Bozeman
Bozeman Deaconess Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Great Falls Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Helena
Saint Peter's Community Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Kalispell
Kalispell Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Missoula
Community Medical Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060

Nebraska

Grand Island
CHI Health Saint Francis
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Kearney
CHI Health Good Samaritan
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Heartland Hematology and Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Lincoln
Saint Elizabeth Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Omaha
Alegent Health Bergan Mercy Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Alegent Health Immanuel Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Alegent Health Lakeside Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Creighton University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Hematology and Oncology Consultants PC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Papillion
Midlands Community Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518

Nevada

Henderson
Comprehensive Cancer Centers of Nevada - Henderson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
OptumCare Cancer Care at Seven Hills
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas
21st Century Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Alliance for Childhood Diseases / Cure 4 the Kids Foundation
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Central Valley
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Northwest
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada-Summerlin
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
OptumCare Cancer Care at Fort Apache
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
OptumCare Cancer Care at MountainView
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
OptumCare Cancer Care at Oakey
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Radiation Oncology Centers of Nevada Central
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Radiation Oncology Centers of Nevada Southeast
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Reno
Radiation Oncology Associates
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Renown Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Saint Mary's Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013

Ohio

Cincinnati
Bethesda North Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Good Samaritan Hospital - Cincinnati
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
TriHealth Cancer Institute-Anderson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
TriHealth Cancer Institute-Westside
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518

Oklahoma

Lawton
Cancer Centers of Southwest Oklahoma Research
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-231-4440
Oklahoma City
University of Oklahoma Health Sciences Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 405-271-8777

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 412-647-8073

South Carolina

Charleston
Medical University of South Carolina
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 843-792-9321

Tennessee

Chattanooga
Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Hixson
Pulmonary Medicine Center of Chattanooga-Hixson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Ooltewah
Memorial GYN Plus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518

Texas

Bryan
Saint Joseph Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Conroe
MD Anderson in The Woodlands
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 866-632-6789
Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 214-648-7097
Houston
Lyndon Baines Johnson General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 713-566-5000
M D Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-632-6789
MD Anderson West Houston
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-632-6789
League City
MD Anderson League City
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-632-6789
Richardson
UT Southwestern Clinical Center at Richardson / Plano
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 972-669-7044
Sugar Land
MD Anderson in Sugar Land
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-632-6789

Virginia

Charlottesville
University of Virginia Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 434-243-6303

Washington

Bellevue
Overlake Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 425-688-5407
Bremerton
Harrison HealthPartners Hematology and Oncology-Bremerton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Harrison Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Burien
Highline Medical Center-Main Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Enumclaw
Saint Elizabeth Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Federal Way
Saint Francis Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Lakewood
Saint Clare Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Poulsbo
Harrison HealthPartners Hematology and Oncology-Poulsbo
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Renton
Valley Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 425-228-3440
Seattle
Fred Hutchinson Cancer Research Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-804-8824
Seattle Cancer Care Alliance
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-804-8824
University of Washington Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-804-8824
Tacoma
Franciscan Research Center-Northwest Medical Plaza
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Northwest Medical Specialties PLLC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518

Wyoming

Cody
Billings Clinic-Cody
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-996-2663
Sheridan
Welch Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060

PRIMARY OBJECTIVES:

I. To evaluate if the regimen of neoadjuvant cisplatin-pemetrexed disodium (pemetrexed)-atezolizumab, surgery +/- radiation, then maintenance atezolizumab is feasible and safe for patients with resectable malignant pleural mesothelioma.

SECONDARY OBJECTIVES:

I. To evaluate progression free survival (both by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 and also using a modified RECIST for pleural tumors) in patients with resectable malignant pleural mesothelioma treated with a regimen of neoadjuvant cisplatin-pemetrexed-atezolizumab, surgery +/- radiation, followed by one year of maintenance atezolizumab.

II. To evaluate overall survival in patients with resectable malignant pleural mesothelioma treated with a regimen of neoadjuvant cisplatin-pemetrexed-atezolizumab, surgery +/- radiation, followed by one year of maintenance atezolizumab.

III. To evaluate response rate (confirmed and unconfirmed, complete and partial, both by RECIST 1.1 and also using a modified RECIST for pleural tumors) in the subset of this patient population with measurable disease.

TRANSLATIONAL MEDICINE OBJECTIVES:

I. To evaluate the association between immunohistochemical (IHC) expression of PD-L1 in tumors and clinical outcomes in mesothelioma patients treated with trimodality/bimodality therapy including atezolizumab (anti-PD-L1).

II. To evaluate the association between expression of immune-related genes identified by Immune Nanostring (depending on ribonucleic acid [RNA] availability) and clinical outcomes in mesothelioma patients treated with trimodality/bimodality therapy including atezolizumab.

III. To evaluate the association between multiplex immunofluorescence (IF) of up to 10 immune markers in two panels and clinical outcomes in mesothelioma patients treated with trimodality/bimodality therapy including atezolizumab.

OUTLINE:

NEOADJUVANT: Patients receive atezolizumab intravenously (IV) over 30-60 minutes, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 2 hours on day 1. Cycles repeats every 21 days for 4 cycles in the absence of disease progression or unexpected toxicity.

SURGERY: Within 21-90 days after completion of neoadjuvant therapy, patients undergo extrapleural pneumonectomy (EPP) or pleurectomy/decortication (PD). Patients who undergo EPP will then undergo radiation therapy (RT).

MAINTENANCE: Within 90 days after completion of either PD or radiation (post-EPP), patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unexpected toxicity.

After completion of study treatment, patients are followed up for up to 3 years.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
SWOG

Principal Investigator
Anne S. Tsao

  • Primary ID S1619
  • Secondary IDs NCI-2017-01230
  • Clinicaltrials.gov ID NCT03228537