Malignant Mesothelioma Clinical Trial
Official title:
Phase II Trial of mTOR Inhibitor, Everolimus (RAD001), in Malignant Pleural Mesothelioma (MPM)
Verified date | February 2020 |
Source | Southwest Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth.
PURPOSE: This phase II trial is studying how well everolimus works in treating patients with
pleural malignant mesothelioma that cannot be removed by surgery.
Status | Completed |
Enrollment | 61 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed malignant pleural mesothelioma - Unresectable disease - Must have measurable or nonmeasurable disease by RECIST or modified RECIST criteria - Must have received prior systemically administered* platinum-based chemotherapy and meets the following criteria: - No more than 2 prior systemic therapeutic regimens allowed (including biologics, targeted, and immunotherapies) - At least 1 regimen must have been platinum-based - Neoadjuvant and/or adjuvant systemic therapy is not counted as a prior regimen, assuming = 12 weeks have elapsed between the end of neoadjuvant/adjuvant therapy and development of progressive disease NOTE: *Pleural space washing with cisplatin does not constitute systemic administration - No known CNS metastases PATIENT CHARACTERISTICS: - Zubrod performance status 0-1 - ANC = 1,500/mm³ - Platelet count = 100,000/mm³ - Serum bilirubin normal - AST or ALT = 1.5 times upper limit of normal (ULN) - Serum creatinine = 1.5 times ULN OR creatinine clearance = 50 mL/min - Not pregnant or nursing - Fertile patients must use effective contraception - No evidence of bleeding diathesis or coagulopathy - Previous pulmonary embolism allowed provided the patient is on therapeutic low molecular weight heparin injections or warfarin AND no evidence of bleeding - Patients on therapeutic warfarin must have an INR of < 5 within 28 days prior to registration - No pathologic condition other than mesothelioma that carries a high risk of bleeding - No known HIV positivity - No gastrointestinal tract disease resulting in an inability to take oral or enteral medication via a feeding tube or a requirement for IV alimentation, or active peptic ulcer disease - No other prior malignancy allowed except for any of 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 - Any other cancer from which patient has been disease-free for 5 years PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Recovered from all prior therapy - At least 28 days since prior systemic therapy (42 days for nitrosoureas or mitomycin C) - At least 28 days since prior thoracic or other major surgery (e.g., pleurectomy or pleurodesis) and no anticipated need for major surgical procedures during study - At least 14 days since prior radiotherapy - No prior surgical procedure affecting absorption - No prior chronic, systemic corticosteroids or other immunosuppressive agent, except corticosteroids equivalent to prednisone = 20 mg daily - Must have been on a stable dosage regimen for = 4 weeks - Topical and inhaled corticosteroids allowed - No prior mTOR inhibitor therapy (i.e., rapamycin, everolimus, or temsirolimus) - No concurrent immunization with attenuated live vaccines - No concurrent antiretroviral therapy for HIV-positive patients - No other concurrent investigational therapy - No other concurrent anticancer agents |
Country | Name | City | State |
---|---|---|---|
United States | San Luis Valley Regional Medical Center | Alamosa | Colorado |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | University of Colorado Cancer Center at UC Health Sciences Center | Aurora | Colorado |
United States | St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana |
United States | Mary Rutan Hospital | Bellefontaine | Ohio |
United States | St. Joseph Cancer Center | Bellingham | Washington |
United States | Billings Clinic - Downtown | Billings | Montana |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana |
United States | St. Vincent Healthcare Cancer Care Services | Billings | Montana |
United States | Bozeman Deaconess Cancer Center | Bozeman | Montana |
United States | Olympic Hematology and Oncology | Bremerton | Washington |
United States | St. James Healthcare Cancer Care | Butte | Montana |
United States | Rocky Mountain Oncology | Casper | Wyoming |
United States | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas |
United States | Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
United States | Clackamas Radiation Oncology Center | Clackamas | Oregon |
United States | CCOP - Columbus | Columbus | Ohio |
United States | Doctors Hospital at Ohio Health | Columbus | Ohio |
United States | Grant Medical Center Cancer Care | Columbus | Ohio |
United States | Mount Carmel Health - West Hospital | Columbus | Ohio |
United States | Riverside Methodist Hospital Cancer Care | Columbus | Ohio |
United States | Danville Regional Medical Center | Danville | Virginia |
United States | CCOP - Dayton | Dayton | Ohio |
United States | David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio |
United States | Good Samaritan Hospital | Dayton | Ohio |
United States | Grandview Hospital | Dayton | Ohio |
United States | Samaritan North Cancer Care Center | Dayton | Ohio |
United States | Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan |
United States | Decatur Memorial Hospital Cancer Care Institute | Decatur | Illinois |
United States | Grady Memorial Hospital | Delaware | Ohio |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas |
United States | Shaw Regional Cancer Center | Edwards | Colorado |
United States | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas |
United States | Blanchard Valley Medical Associates | Findlay | Ohio |
United States | Genesys Hurley Cancer Institute | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas |
United States | Middletown Regional Hospital | Franklin | Ohio |
United States | Northeast Georgia Medical Center | Gainesville | Georgia |
United States | Valley View Hospital Cancer Center | Glenwood Springs | Colorado |
United States | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina |
United States | Great Falls Clinic - Main Facility | Great Falls | Montana |
United States | Sletten Cancer Institute at Benefis Healthcare | Great Falls | Montana |
United States | Wayne Hospital | Greenville | Ohio |
United States | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan |
United States | Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford | Connecticut |
United States | Northern Montana Hospital | Havre | Montana |
United States | St. Peter's Hospital | Helena | Montana |
United States | M. D. Anderson Cancer Center at University of Texas | Houston | Texas |
United States | Cancer Center of Kansas-Independence | Independence | Kansas |
United States | Foote Memorial Hospital | Jackson | Michigan |
United States | Glacier Oncology, PLLC | Kalispell | Montana |
United States | Kalispell Medical Oncology at KRMC | Kalispell | Montana |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | Columbia Basin Hematology | Kennewick | Washington |
United States | Charles F. Kettering Memorial Hospital | Kettering | Ohio |
United States | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas |
United States | Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport | Tennessee |
United States | U.T. Medical Center Cancer Institute | Knoxville | Tennessee |
United States | Fairfield Medical Center | Lancaster | Ohio |
United States | Sparrow Regional Cancer Center | Lansing | Michigan |
United States | Lawrence Memorial Hospital | Lawrence | Kansas |
United States | Cancer Center of Kansas, PA - Liberal | Liberal | Kansas |
United States | St. Mary Mercy Hospital | Livonia | Michigan |
United States | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California |
United States | Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio |
United States | Tibotec Therapeutics - Division of Ortho Biotech Products, LP | Marysville | California |
United States | Providence Milwaukie Hospital | Milwaukie | Oregon |
United States | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana |
United States | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana |
United States | Montrose Memorial Hospital Cancer Center | Montrose | Colorado |
United States | Knox Community Hospital | Mount Vernon | Ohio |
United States | Skagit Valley Hospital Cancer Care Center | Mount Vernon | Washington |
United States | Edward Hospital Cancer Center | Naperville | Illinois |
United States | Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio |
United States | Providence Newberg Medical Center | Newberg | Oregon |
United States | Cancer Center of Kansas, PA - Newton | Newton | Kansas |
United States | Southwest Virginia Regional Cancer Center at Wellmonth Health | Norton | Virginia |
United States | Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange | California |
United States | Willamette Falls Hospital | Oregon City | Oregon |
United States | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas |
United States | Valley Medical Oncology Consultants - Pleasanton | Pleasanton | California |
United States | St. Joseph Mercy Oakland | Pontiac | Michigan |
United States | Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan |
United States | CCOP - Columbia River Oncology Program | Portland | Oregon |
United States | Providence Cancer Center at Providence Portland Medical Center | Portland | Oregon |
United States | Providence St. Vincent Medical Center | Portland | Oregon |
United States | Harrison Poulsbo Hematology and Onocology | Poulsbo | Washington |
United States | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas |
United States | Reid Hospital & Health Care Services | Richmond | Indiana |
United States | University of California Davis Cancer Center | Sacramento | California |
United States | Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan |
United States | Cancer Center of Kansas, PA - Salina | Salina | Kansas |
United States | Tammy Walker Cancer Center at Salina Regional Health Center | Salina | Kansas |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
United States | Group Health Central Hospital | Seattle | Washington |
United States | Harborview Medical Center | Seattle | Washington |
United States | Minor and James Medical, PLLC | Seattle | Washington |
United States | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington |
United States | University Cancer Center at University of Washington Medical Center | Seattle | Washington |
United States | Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming |
United States | Cancer Care Northwest - Spokane South | Spokane | Washington |
United States | Evergreen Hematology and Oncology, PS | Spokane | Washington |
United States | Community Hospital of Springfield and Clark County | Springfield | Ohio |
United States | Regional Cancer Center at Memorial Medical Center | Springfield | Illinois |
United States | Iredell Memorial Hospital | Statesville | North Carolina |
United States | UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio |
United States | Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson | Arizona |
United States | Northwest Cancer Specialists at Vancouver Cancer Center | Vancouver | Washington |
United States | Southwest Washington Medical Center Cancer Center | Vancouver | Washington |
United States | St. John Macomb Hospital | Warren | Michigan |
United States | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas |
United States | Wenatchee Valley Medical Center | Wenatchee | Washington |
United States | Mount Carmel St. Ann's Cancer Center | Westerville | Ohio |
United States | Associates in Womens Health, PA - North Review | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Wichita | Wichita | Kansas |
United States | CCOP - Wichita | Wichita | Kansas |
United States | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas |
United States | Clinton Memorial Hospital | Wilmington | Ohio |
United States | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas |
United States | Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio |
United States | Genesis - Good Samaritan Hospital | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
Southwest Oncology Group | National Cancer Institute (NCI) |
United States,
Garland LL, Ou SH, Moon J, et al.: SWOG 0722: A phase II study of mTOR inhibitor everolimus (RAD001) in malignant pleural mesothelioma (MPM). [Abstract] J Clin Oncol 30 (Suppl 15): A-7083, 2012.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-Free Survival | Progression-Free Survival was defined as the duration from the date of registration until the date of disease progression per RECIST or death due to any cause. Patients known to be alive without evidence of disease progression were censored at the date of last contact. Disease progression was defined as a >= 20% increase over nadir in the sum of longest diameters of target lesions, unequivocal progression of non-target lesions in the opinion of the treating investigator, appearance of new lesions, symptomatic deterioration, or death due to disease | Every 8 weeks until disease progression, up to 3 years. | |
Secondary | Response | A response was defined as either a confirmed or unconfirmed complete or partial responses as defined by RECIST. A complete response (CR) was defined as the disappearance of all disease. A partial response (PR) was defined as a >= 30% decrease in the sum of longest diameters of target lesions. A CR or PR was considered confirmed if two consecutive determinations were made at least 4 weeks apart. | Every 8 weeks until disease progression, up to 3 years. | |
Secondary | Overall Survival | Overall survival was defined as the duration between the date of enrollment and the date of death due to any cause. Patients last known to be alive were censored at the date of last contact. | Every 8 weeks until disease progression, up to 3 years. | |
Secondary | Frequency and Severity of Toxicities | Weekly during the first 8 weeks of treatment, then every 4 weeks while on treatment, then every 8 weeks until disease progression, then every 6 months thereafter. |
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