Temozolomide and Radiation Therapy With or Without Cediranib Maleate in Treating Patients With Newly Diagnosed Glioblastoma
NCT ID: NCT01062425
Last Updated: 2022-07-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
261 participants
INTERVENTIONAL
2010-02-26
2022-05-20
Brief Summary
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Detailed Description
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I. To determine if the addition of cediranib (cediranib maleate) to chemoradiation treatment enhances treatment efficacy as measured by the 6-month progression-free survival rate.
SECONDARY OBJECTIVES:
I. To determine if the addition of cediranib to chemoradiation treatment enhances treatment efficacy as measured by overall survival.
II. To determine if the addition of cediranib to chemoradiation treatment enhances treatment efficacy as measured by progression-free survival.
III. To determine if there is an association between tumor O6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) gene methylation status and treatment response and outcome.
IV. To compare and record the toxicities of the cediranib + chemoradiation arm versus the chemoradiation arm.
V. To evaluate whether 6-month progression-free survival is associated with overall survival.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive cediranib maleate orally (PO) once daily (QD) for 3 days. Patients then undergo radiation therapy (intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy) QD, 5 days a week, for 6 weeks and receive temozolomide PO QD and cediranib maleate PO QD for 6 weeks. Patients then receive temozolomide PO QD alone on days 1-5. Treatment with temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO QD for 3 days. Patients then undergo radiation therapy (intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy) QD, 5 days a week, for 6 weeks and receive temozolomide PO QD and placebo PO QD for 6 weeks. Patients then receive temozolomide PO QD alone on days 1-5. Treatment with temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cediranib, TMZ, and RT
Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum.
3-Dimensional Conformal Radiation Therapy
Undergo 3-dimensional conformal radiotherapy
Cediranib Maleate
Given PO
Intensity-Modulated Radiation Therapy
Undergo intensity-modulated radiation therapy
Laboratory Biomarker Analysis
Correlative studies
Temozolomide
Given PO
Placebo, TMZ, and RT
Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum.
3-Dimensional Conformal Radiation Therapy
Undergo 3-dimensional conformal radiotherapy
Intensity-Modulated Radiation Therapy
Undergo intensity-modulated radiation therapy
Laboratory Biomarker Analysis
Correlative studies
Placebo Administration
Given PO
Temozolomide
Given PO
Interventions
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3-Dimensional Conformal Radiation Therapy
Undergo 3-dimensional conformal radiotherapy
Cediranib Maleate
Given PO
Intensity-Modulated Radiation Therapy
Undergo intensity-modulated radiation therapy
Laboratory Biomarker Analysis
Correlative studies
Placebo Administration
Given PO
Temozolomide
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Tumor tissue that is determined by central pathology review prior to step 2 registration to be of sufficient size for analysis of MGMT status
* Patients must have at least 1 block of tumor tissue; submission of 2 blocks is strongly encouraged
* Cavitron ultrasonic aspirator (CUSA)-derived material is not allowed; fresh frozen tumor tissue acquisition is encouraged
* Diagnosis must be made by surgical excision, either partial or complete; stereotactic biopsy is not allowed because it will not provide sufficient tissue for MGMT analysis
* The tumor tissue must be sent as soon as possible to maximize the likelihood of eligibility; tumor tissue may not be submitted later than 28 days after the surgical procedure, because tissue analysis will not be able to be performed in time for treatment to commence by the mandatory 6-week post-surgery outer limit; submission of tissue earlier than 28 days post-surgery is highly recommended
* The tumor must have a supratentorial component
* History/physical examination, including neurologic examination, within 14 days prior to step 2 registration
* The patient must have recovered from the effects of surgery, post-operative infection, and other complications before step 2 registration
* A diagnostic contrast-enhanced magnetic resonance imaging (MRI) of the brain must be performed preoperatively and postoperatively prior to step 1 registration; the postoperative scan must be performed within 28 days prior to step 1 registration
* Documentation of steroid doses/concurrent medications within 14 days prior to step 2 registration
* Karnofsky performance status \>= 70 within 14 days prior to step 2 registration
* Complete blood count (CBC)/differential obtained within 14 days prior to step 2 registration on study, with adequate bone marrow function defined as follows:
* Absolute neutrophil count (ANC) \>= 1,800 cells/mm\^3
* Platelets \>= 100,000 cells/mm\^3
* Hemoglobin \>=10.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin (Hgb) \>= 10.0 g/dl is acceptable)
* Adequate renal function, as defined below:
* Blood urea nitrogen (BUN) =\< 30 mg/dl within 14 days prior to step 2 registration
* Creatinine =\< 1.7 mg/dl within 14 days prior to step 2 registration
* Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =\< 3 x normal range within 14 days prior to step 2 registration
* Systolic blood pressure =\< 140 mm Hg AND diastolic pressure =\< 90 mm Hg within 14 days prior to step 2 registration in the presence or absence of a stable regimen of anti-hypertensive therapy
* Prothrombin time/international normalized ratio (PT INR) \< 1.4 for patients not on warfarin confirmed by testing within 1 week of step 2 registration
* Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight \[LMW\] heparin) must meet both of the following criteria:
* No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
* In-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
* Patient must provide study specific informed consent prior to step 1 registration
* Women of childbearing potential and male participants must practice adequate contraception
* For females of child-bearing potential, negative serum pregnancy test within 14 days prior to step 2 registration
Exclusion Criteria
* Recurrent or multifocal malignant gliomas
* Metastases detected below the tentorium or beyond the cranial vault
* Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable (except temozolomide or cediranib); prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted
* Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields
* Severe, active co-morbidity, defined as follows:
* Unstable angina and/or congestive heart failure requiring hospitalization
* Transmural myocardial infarction within the last 6 months
* Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of \>= 2 mm using the analysis of an electrocardiogram (EKG) performed within 14 days of step 2 registration
* New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to step 2 registration
* History of stroke, cerebral vascular accident (CVA) or transient ischemic attack within 6 months
* Serious and inadequately controlled cardiac arrhythmia
* Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease
* Evidence of bleeding diathesis or coagulopathy
* Serious or non-healing wound, ulcer, or bone fracture or history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to step 2 registration, with the exception of the craniotomy for tumor resection
* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 2 registration
* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
* Active connective tissue disorders, such as lupus or scleroderma, which in the opinion of the treating physician may put the patient at high risk for radiation toxicity
* Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy
* Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
* Pregnant or lactating women
* Prior allergic reaction to temozolomide
* Patients treated on any other therapeutic clinical protocols within 30 days prior to step 1 registration or during participation in the study
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib
* Mean QTc \>500 msec (with Bazett's correction) in screening electrocardiogram or history of familial long QT syndrome or other significant ECG abnormality noted within 14 days of treatment
* Patients receiving concurrent vascular endothelial growth factor (VEGF) inhibitors are prohibited from participating in this study
* Patients must not be on enzyme-inducing anti-epileptic drugs (EIAED); patients may be on non-enzyme inducing anti-epileptic drugs (NEIAED) or may not be taking any anti-epileptic drugs; in patients who have previously been on EIAED there must be at least a 14 day period since the last dose of an EIAED before the first dose of cediranib
18 Years
ALL
No
Sponsors
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NRG Oncology
OTHER
Radiation Therapy Oncology Group
NETWORK
National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Tracy T Batchelor
Role: PRINCIPAL_INVESTIGATOR
NRG Oncology
Locations
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
The Kirklin Clinic at Acton Road
Birmingham, Alabama, United States
Arizona Oncology Services Foundation
Scottsdale, Arizona, United States
Banner University Medical Center - Tucson
Tucson, Arizona, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Saint Joseph Hospital - Orange
Orange, California, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
AdventHealth Orlando
Orlando, Florida, United States
Bay Medical Center
Panama City, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Queen's Medical Center
Honolulu, Hawaii, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Radiation Oncology Associates PC
Fort Wayne, Indiana, United States
Parkview Hospital Randallia
Fort Wayne, Indiana, United States
IU Health Methodist Hospital
Indianapolis, Indiana, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Maine Medical Center- Scarborough Campus
Scarborough, Maine, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Ascension Saint John Hospital
Detroit, Michigan, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Sparrow Hospital
Lansing, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Lake Huron Medical Center
Port Huron, Michigan, United States
Ascension Saint Mary's Hospital
Saginaw, Michigan, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Sparta Cancer Treatment Center
Sparta, New Jersey, United States
University of Rochester
Rochester, New York, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Summa Health System - Akron Campus
Akron, Ohio, United States
Cleveland Clinic Akron General
Akron, Ohio, United States
Summa Health System - Barberton Campus
Barberton, Ohio, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University Hospitals Portage Medical Center
Ravenna, Ohio, United States
UH Seidman Cancer Center at Salem Regional Medical Center
Salem, Ohio, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States
Cancer Treatment Center
Wooster, Ohio, United States
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Jefferson Abington Hospital
Abington, Pennsylvania, United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania, United States
Reading Hospital
West Reading, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
McKay-Dee Hospital Center
Ogden, Utah, United States
Utah Valley Regional Medical Center
Provo, Utah, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Saint George Regional Medical Center
St. George, Utah, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
University of Washington Medical Center - Montlake
Seattle, Washington, United States
Compass Oncology Vancouver
Vancouver, Washington, United States
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States
Countries
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Other Identifiers
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NCI-2011-02012
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000665163
Identifier Type: -
Identifier Source: secondary_id
RTOG-0837
Identifier Type: -
Identifier Source: secondary_id
RTOG 0837
Identifier Type: OTHER
Identifier Source: secondary_id
RTOG-0837
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-02012
Identifier Type: -
Identifier Source: org_study_id
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