Dasatinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma
Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme
6 other identifiers
interventional
64
3 countries
188
Brief Summary
This phase II trial studies how well dasatinib works in treating patients with glioblastoma multiforme or gliosarcoma that has come back. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2007
Longer than P75 for phase_2
188 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2007
CompletedFirst Posted
Study publicly available on registry
January 18, 2007
CompletedStudy Start
First participant enrolled
January 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2011
CompletedResults Posted
Study results publicly available
January 6, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2018
CompletedJuly 24, 2019
July 1, 2019
4.1 years
January 16, 2007
June 19, 2014
July 22, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Patients Achieving 6-month Progression-free Survival (6mPFS)
This study utilized a two-stage phase II design (Stage 1B and 2). The primary endpoint of 6-month progression-free survival (6mPFS) would be assessed based on the patients combined from 1B and 2 if the study continued to Stage 2. Null hypothesis = 11%; alternative hypothesis = 25%. Simon's minmax 2-stage design was used with type I and type II error both set at 10%. If the first stage met its criteria (see secondary outcome measure), then accrual would continue, otherwise there would be no further accrual and the alternative hypothesis would be rejected. Following Stage 2 accrual completion and 6 months of follow-up, if 9 or more patients were alive without progression by 6 months, the null hypothesis would be rejected in favor of the alternative.
Registration to 6 months
Secondary Outcomes (7)
Number of Patients Achieving Objective Response (Partial or Complete Response) OR 6-month Progression-free Survival (6mPFS)
Registration to 6 months
Overall Survival
Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.)
Treatment Response Rates at Six Months
From registration to 6 months
Progression-free Survival
Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.)
Rate of Adverse Events
Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.)
- +2 more secondary outcomes
Study Arms (1)
Treatment (dasatinib)
EXPERIMENTALPatients receive dasatinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically proven diagnosis of GBM; gliosarcoma is also an eligible diagnosis
- The patient must consent to submission of tissue for central pathology review
- Patients who have already undergone central pathology review through their enrollment on another Radiation Therapy Oncology Group (RTOG) GBM trial do not need to consent to having their material re-reviewed by the central pathologist for this study
- All patients must consent to molecular analysis of pre-dasatinib tumor tissue
- Patients accrued to stage I (closed to accrual) or stage IB (opened to accrual May 5, 2009) must have tumors overexpressing at least 2 known dasatinib targets (i.e., SRC proto-oncogene, non-receptor tyrosine kinase \[SRC\], v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog \[KIT\], platelet-derived growth factor receptor \[PDGFR\], or ephrin type-A receptor 2 \[EPHA2\])
- Patients accrued to stage II (cohort closed; not currently applicable) do not require overexpression of SRC, KIT, PDGFR, or EPHA2
- History and physical examination, including height and weight, within 10 days prior to registration on study
- Brain magnetic resonance imaging (MRI) with and without gadolinium within 10 days prior to registration on study
- Contrast-enhanced computed tomography (CT) scans are allowed for patients who cannot undergo MRI scanning
- Karnofsky performance status \>= 60
- Absolute neutrophil count (ANC) \>= 1,000 cells/mm\^3
- Platelets \>= 75,000 cells/mm\^3
- Hemoglobin (Hgb) \>= 8.0 g/dl; (note: the use of transfusion or other intervention to achieve Hgb \>= 8.0 g/dl is acceptable)
- Leukocytes \>= 3,000 cells/mm\^3
- Absolute lymphocyte count (ALC) \>= 500 cells/mm\^3
- +14 more criteria
You may not qualify if:
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
- Radiotherapy within 4 weeks or temozolomide within 14 days prior to registration or failure to recover from adverse events of either radiotherapy or temozolomide
- Patients may not be receiving any other investigational agents
- Severe, active comorbidity, defined as follows:
- Any clinically significant cardiovascular disease including the following:
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- Transmural myocardial infarction or ventricular tachyarrhythmia within the past 6 months
- Prolonged corrected QT interval (QTc) \> 480 msec (Fridericia correction)
- Ejection fraction less than institutional normal
- Major conduction abnormality (unless a cardiac pacemaker is present)
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; breastfeeding should be discontinued if the mother is treated with dasatinib
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)lead
- Radiation Therapy Oncology Groupcollaborator
- NRG Oncologycollaborator
Study Sites (188)
Mobile Infirmary Medical Center
Mobile, Alabama, 36607, United States
Arizona Oncology Services Foundation
Scottsdale, Arizona, 85260, United States
The University of Arizona Medical Center-University Campus
Tucson, Arizona, 85724, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682, United States
Mercy San Juan Medical Center
Carmichael, California, 95608, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Glendale Adventist Medical Center
Glendale, California, 91206, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Mercy General Hospital Radiation Oncology Center
Sacramento, California, 95819, United States
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, 95687, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
Boca Raton Regional Hospital
Boca Raton, Florida, 33486, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
Integrated Community Oncology Network-Southside Cancer Center
Jacksonville, Florida, 32207, United States
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, 32209, United States
Baptist Medical Center South
Jacksonville, Florida, 32258, United States
Integrated Community Oncology Network-Florida Cancer Center Beaches
Jacksonville Beach, Florida, 32250, United States
Jupiter Medical Center
Jupiter, Florida, 33458, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
21st Century Oncology-Orange Park
Orange Park, Florida, 32073, United States
21st Century Oncology-Palatka
Palatka, Florida, 32177, United States
Bay Medical Center
Panama City, Florida, 32401, United States
Integrated Community Oncology Network-Flager Cancer Center
Saint Augustine, Florida, 32086, United States
John B Amos Cancer Center
Columbus, Georgia, 31904, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Saint John's Hospital
Springfield, Illinois, 62702, United States
Saint Vincent Anderson Regional Hospital/Cancer Center
Anderson, Indiana, 46016, United States
Franciscan Saint Francis Health-Beech Grove
Beech Grove, Indiana, 46107, United States
IU Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
Reid Health
Richmond, Indiana, 47374, United States
Menorah Medical Center
Overland Park, Kansas, 66209, United States
Saint Luke's South Hospital
Overland Park, Kansas, 66213, United States
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, 66208, United States
Shawnee Mission Medical Center-KCCC
Shawnee Mission, Kansas, 66204, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202, United States
Union Hospital of Cecil County
Elkton, Maryland, 21921, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, 48106, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
Beaumont Hospital-Dearborn
Dearborn, Michigan, 48124, United States
Ascension Saint John Hospital
Detroit, Michigan, 48236, United States
Green Bay Oncology - Escanaba
Escanaba, Michigan, 49829, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, 48532, United States
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, 49801, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Borgess Medical Center
Kalamazoo, Michigan, 49048, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Saint Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
Lake Huron Medical Center
Port Huron, Michigan, 48060, United States
Saint Mary's of Michigan
Saginaw, Michigan, 48601, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview-Southdale Hospital
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Singing River Hospital
Pascagoula, Mississippi, 39581, United States
Cape Radiation Oncology
Cape Girardeau, Missouri, 63703, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
Centerpoint Medical Center LLC
Independence, Missouri, 64057, United States
Truman Medical Center
Kansas City, Missouri, 64108, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Saint Joseph Health Center
Kansas City, Missouri, 64114, United States
North Kansas City Hospital
Kansas City, Missouri, 64116, United States
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, 64118, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, 64086, United States
Liberty Radiation Oncology Center
Liberty, Missouri, 64068, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64507, United States
Cancer Research for the Ozarks NCORP
Springfield, Missouri, 65804, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Cheshire Medical Center-Dartmouth-Hitchcock Keene
Keene, New Hampshire, 03431, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Virtua Memorial
Mount Holly, New Jersey, 08060, United States
Sparta Cancer Treatment Center
Sparta, New Jersey, 07871, United States
Virtua Voorhees
Voorhees Township, New Jersey, 08043, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Highland Hospital
Rochester, New York, 14620, United States
University of Rochester
Rochester, New York, 14642, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Rutherford Hospital
Rutherfordton, North Carolina, 28139, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, 44304, United States
Cleveland Clinic Akron General
Akron, Ohio, 44307, United States
Summa Barberton Hospital
Barberton, Ohio, 44203, United States
Aultman Health Foundation
Canton, Ohio, 44710, United States
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio, 45219, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Health Center
Dayton, Ohio, 45415, United States
Veteran Affairs Medical Center
Dayton, Ohio, 45428, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
UH Seidman Cancer Center at Salem Regional Medical Center
Salem, Ohio, 44460, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
University Pointe
West Chester, Ohio, 45069, United States
Cancer Treatment Center
Wooster, Ohio, 44691, United States
Greene Memorial Hospital
Xenia, Ohio, 45385, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Salem Hospital
Salem, Oregon, 97301, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026, United States
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, 18512, United States
Adams Cancer Center
Gettysburg, Pennsylvania, 17325, United States
Cherry Tree Cancer Center
Hanover, Pennsylvania, 17331, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Upper Delaware Valley Cancer Center
Milford, Pennsylvania, 18337, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
WellSpan Health-York Hospital
York, Pennsylvania, 17403, United States
AnMed Health Hospital
Anderson, South Carolina, 29621, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Saint Francis Hospital
Greenville, South Carolina, 29601, United States
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, 29615, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, 37660, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916, United States
Thompson Cancer Survival Center - West
Knoxville, Tennessee, 37932, United States
Thompson Cancer Survival Center at Methodist
Oak Ridge, Tennessee, 37830, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Covenant Medical Center-Lakeside
Lubbock, Texas, 79410, United States
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, 84003, United States
Sandra L Maxwell Cancer Center
Cedar City, Utah, 84720, United States
Logan Regional Hospital
Logan, Utah, 84321, United States
Cottonwood Hospital Medical Center
Murray, Utah, 84107, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center
Provo, Utah, 84604, United States
Intermountain Health Care
Salt Lake City, Utah, 84103, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Dixie Medical Center Regional Cancer Center
St. George, Utah, 84770, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Vermont College of Medicine
Burlington, Vermont, 05405, United States
Norris Cotton Cancer Center-North
Saint Johnsbury, Vermont, 05819, United States
Southwest VA Regional Cancer Center
Norton, Virginia, 24273, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, 98902, United States
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, 26003, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, 54301-3526, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, 54303, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Québec, Quebec, G1R 2J6, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
King Faisal Specialist Hospital and Research Centre
Riyadh, 11211, Saudi Arabia
Related Publications (1)
Lassman AB, Pugh SL, Gilbert MR, Aldape KD, Geinoz S, Beumer JH, Christner SM, Komaki R, DeAngelis LM, Gaur R, Youssef E, Wagner H, Won M, Mehta MP. Phase 2 trial of dasatinib in target-selected patients with recurrent glioblastoma (RTOG 0627). Neuro Oncol. 2015 Jul;17(7):992-8. doi: 10.1093/neuonc/nov011. Epub 2015 Mar 10.
PMID: 25758746DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Designed as a 2-stage study. The protocol was amended after Stage 1 to add Stage 1B allowing intra-patient escalation. Per protocol criteria, the study did not continue to Stage 2.
Results Point of Contact
- Title
- Wendy Seiferheld
- Organization
- Radiation Therapy Oncology Group (RTOG)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Lassman
NRG Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2007
First Posted
January 18, 2007
Study Start
January 24, 2007
Primary Completion
March 9, 2011
Study Completion
September 4, 2018
Last Updated
July 24, 2019
Results First Posted
January 6, 2015
Record last verified: 2019-07