AzTrials
AzTrials

Glioblastoma MultiformePhase 2NCT00892177

Dasatinib and Bevacizumab in Treating Patients With Recurrent or Progressive High-Grade Glioma or Glioblastoma Multiforme

A Phase 2 study testing bevacizumab and dasatinib in people with Glioblastoma Multiforme, run by Alliance for Clinical Trials in Oncology at 305 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma Multiforme
What is being tested?
bevacizumab and dasatinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
144 participants
Where
305 sitesUnited States
Study dates
Oct 2009to 1 Jul 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Patient Eligibility:

  1. Pre-registration:
  2. Central pathology review submission. This review is mandatory prior to registration to confirm eligibility.

II. Registration Inclusion Criteria:

  1. ≥18 years of age
  2. Study 1: Histologic confirmation of grade 3 or 4 glioma, including astrocytoma, oligodendroglioma, and mixed gliomas, as determined by pre-registration central pathology review.
  3. Study 2: Histological confirmation of glioblastoma multiforme (grade 4 astrocytoma) as determined by pre-registration central pathology review. NOTE: Variant gliosarcomas are eligible
  4. Evidence of tumor progression by MRI or CT scan following RT or following the most recent anti-tumor therapy. Patients who had surgical treatment at recurrence are eligible if there is imaging evidence of disease progression as compared to the first postoperative scan.
  5. Bidimensionally measurable or evaluable disease by MRI or CT scan.
  6. ECOG Performance Status (PS) 0, 1, or 2.
  7. Patient willing to discontinue use of aspirin or medications that inhibit platelet function ≥ 1 week prior to registration.
  8. Previous RT and ≥12 weeks since the completion of RT prior to registration.
  9. The following laboratory values obtained ≤ 21 days prior to registration.
  • ANC ≥1500
  • PLT ≥100,000
  • Hgb >9.0 g/dL
  • T. bili ≤1.5 x ULN
  • SGOT (AST) ≤ 3 x ULN
  • Creatinine ≤ ULN
  1. UPC ratio <1. NOTE: Urine protein must be screened by urine analysis for Urine Protein Creatinine (UPC) ratio. For UPC ratio ≥1.0, 24-hour urine protein must be obtained and the level should be <1000 mg
  2. Negative pregnancy test done ≤7 days prior to registration, for women of childbearing potential only.
  3. Ability to complete questionnaire(s) by themselves or with assistance.
  4. Provide informed written consent
  5. Willingness to return to enrolling institution for follow-up.
  6. Patient willing to provide mandatory tissue samples for research purposes
  7. Study 1: Any number of prior chemotherapy regimens for recurrent disease. Study 2: Up to 2 prior chemotherapy regimens with ≤1 regimen for recurrent disease.

III. Exclusion Criteria:

  1. Pregnant women, nursing women and men or women of childbearing potential who are unwilling to employ adequate contraception during this study and for up to 6 months after bevacizumab treatment has ended. NOTE: bevacizumab and dasatinib are investigational agents whose genotoxic effects on the developing fetus and newborn are unknown.
  2. Prior intratumoral therapy, stereotactic radiosurgery, or interstitial brachytherapy. EXCEPTION: Separate lesion on MRI which is not part of the previous treatment field, or convincing evidence of recurrent disease, based on biopsy, MRI spectroscopy, or PET scan.
  3. Prior treatment with bevacizumab or VEGF-Trap (Aflibercept).
  4. Inadequately controlled hypertension (systolic blood pressure of >150 mmHg or diastolic pressure >100 mmHg on anti-hypertensive medications). NOTE: Patients with well-controlled hypertension are eligible.
  5. Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  6. Immunocompromised patients (other than that related to the use of corticosteroids). NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this study.
  7. Any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, or prior surgical procedures affecting absorption) that impairs ability to swallow pills.
  8. Receiving therapeutic anticoagulation with Warfarin. NOTE: Prophylactic anticoagulation (i.e., low dose warfarin) of venous or arterial access devices is allowed, provided that INR <1.5. Therapeutic anti-coagulation with low molecular weight heparin is allowed at time of registration.
  9. Evidence of bleeding diathesis (greater than normal risk of bleeding) or coagulopathy (in the absence of therapeutic anticoagulation).
  10. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
  11. Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
  12. Other active malignancy ≤3 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma in-situ of the cervix. Note: If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer.
  13. History of myocardial infarction or unstable angina ≤6 months prior to registration.
  14. New York Heart Association (NYHA) classification II, III or IV congestive heart failure.
  15. Core biopsy or other minor surgical procedures ≤7 days prior to registration. Note: Placement of a vascular access device is allowed.
  16. Major surgical procedure, open biopsy, or significant traumatic injury ≤28 days prior to registration or anticipation of need for major surgical procedure during the course of the study.
  17. Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis ≤6 months prior to registration.
  18. History of hypertensive crisis or hypertensive encephalopathy.
  19. Known hypersensitivity to any of the components of dasatinib or bevacizumab.
  20. Serious, non-healing wound, active ulcer, or untreated bone fracture
  21. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess ≤6 months prior to registration.
  22. Active or recent history of hemoptysis (≥ ½ teaspoon of bright red blood per episode) ≤30 days prior to registration.
  23. History of stroke or transient ischemic attack (TIA) ≤6 months prior to registration.
  24. Any evidence of CNS hemorrhage on baseline CT or MRI
  25. Any of the following Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes ≤7 days prior to registration (patients must discontinue drug 7 days prior to starting dasatinib)
  • Quinidine, procainamide, disopyramide
  • Amiodarone, sotalol, ibutilide, dofetilide
  • Erythromycin, clarithromycin
  • Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide
  • Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
  • Prochlorperazine
  1. Diagnosed congenital long QT syndrome
  2. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes)
  3. Prolonged QTc interval on pre-entry electrocardiogram (>450 msec)
  4. Patients may not have any clinically significant cardiovascular disease including the following:
  • Myocardial infarction or ventricular tachyarrhythmia within 6 months.
  • Prolonged QTc ≥ 480 msec (Fridericia correction)
  • Ejection fraction less than institutional normal
  • Major conduction abnormality (unless a cardiac pacemaker is present) Note: Patients with any cardiopulmonary symptoms of unknown cause (e.g., shortness of breath, chest pain, etc.) should be evaluated by a baseline echocardiogram with or without stress test as needed in addition to electrocardiogram (ECG) to rule out QTc prolongation. The patient may be referred to a cardiologist at the discretion of the principal investigator. Patients with underlying cardiopulmonary dysfunction should be excluded from the study.
  1. Subjects with hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration
  2. Known pleural or pericardial effusion of any grade
  3. Concomitant use of H2 blockers or proton pump inhibitors that cannot be discontinued or switched to locally acting agents (i.e. famotidine or omeprazole.)
  4. Use of the following Enzyme Inducing Anti-Convulsive (EIAC) medications is prohibited ≤ 7 days prior to registration: carbamazepine (Tegretol®, Tegretol XR®, Carbatrol®), phenytoin (Dilantin®, Phenytek®), fosphenytoin (Cerebyx®), phenobarbital, pentobarbital and primidone (Mysoline®). Note: Many antiepileptic drugs induce hepatic enzymes. Because dasatinib is metabolized by hepatic enzymes, patients taking antiepileptic medications that induce hepatic enzymes (EIACs) are ineligible for this trial. To be eligible for this trial, patients taking EIACs must be switched to non-EIACs ≥ 7 days prior to registration. The following agents are not known to affect dasatinib metabolism and are acceptable for use: valproic acid (Depakote®, Depacon®), gabapentin (Neurontin®), lamotrigine (Lamictal®), topiramate (Topamax®), tiagabine (Gabitril®), zonisamide (Zonegran®), levetiracetam (Keppra®), clonazepam (Klonopin®) and clobazam (Frisium®).

Trial locations and contacts

305 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Kapiolani Medical Center at Pali Momi

    ‘Aiea, Hawaii, 96701

  • Oncare Hawaii, Incorporated - Pali Momi

    ‘Aiea, Hawaii, 96701

  • Bixby Medical Center

    Adrian, Michigan, 49221

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • Toledo Clinic Cancer Centers - Adrian

    Adrian, Michigan, 49221

  • Toledo Clinic Cancer Centers-Adrian

    Adrian, Michigan, 49221

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

  • Aurora Presbyterian Hospital

    Aurora, Colorado, 80012

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60504

  • CancerCare of Maine at Eastern Maine Medical Center

    Bangor, Maine, 04401

  • MeritCare Bemidji

    Bemidji, Minnesota, 56601

  • Sanford Clinic North-Bemidji

    Bemidji, Minnesota, 56601

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Frontier Cancer Center and Blood Institutes-Billings

    Billings, Montana, 59102

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59102

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Billings Clinic

    Billings, Montana, 59107-7000

  • Medcenter One Hospital Cancer Care Center

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center Cancer Center

    Bismarck, North Dakota, 58502

  • Illinois CancerCare - Bloomington

    Bloomington, Illinois, 61701

  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Boulder Community Hospital

    Boulder, Colorado, 80301-9019

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Illinois CancerCare - Canton

    Canton, Illinois, 61520

  • Illinois CancerCare - Carthage

    Carthage, Illinois, 62321

  • Cedar Rapids Oncology Association

    Cedar Rapids, Iowa, 52403

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Medical Oncology and Hematology Associates - West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center - West Lakes

    Clive, Iowa, 50325

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • John B Amos Cancer Center

    Columbus, Georgia, 31904

  • New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care

    Concord, New Hampshire, 03301

  • New Hampshire Oncology-Hematology PA

    Concord, New Hampshire, 03301

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • CCOP - Dayton

    Dayton, Ohio, 45420

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • St. Anthony Central Hospital

    Denver, Colorado, 80204

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Presbyterian - St. Luke's Medical Center

    Denver, Colorado, 80218

  • St. Joseph Hospital

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa, 50314

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Essentia Health - Duluth Clinic

    Duluth, Minnesota, 55805-1983

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller - Dwan Medical Center

    Duluth, Minnesota, 55805

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Union Hospital of Cecil County

    Elkton, Maryland, 21921

  • Community Cancer Center

    Elyria, Ohio, 44035

  • Hematology Oncology Center

    Elyria, Ohio, 44035

  • Swedish Medical Center

    Englewood, Colorado, 80110

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • Illinois CancerCare - Eureka

    Eureka, Illinois, 61530

  • MeritCare Broadway

    Fargo, North Dakota, 58102

  • Sanford Clinic North-Fargo

    Fargo, North Dakota, 58102

  • Dakota Cancer Institute at Dakota Clinic - South University

    Fargo, North Dakota, 58103

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota, 58103

  • Sanford Medical Center-Fargo

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Hurley Medical Center

    Flint, Michigan, 48503

  • McLeod Regional Medical Center

    Florence, South Carolina, 29501

  • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005

  • Fredericksburg Oncology, Incorporated

    Fredericksburg, Virginia, 22401

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Galesburg Clinic, PC

    Galesburg, Illinois, 61401

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Altru Cancer Center at Altru Hospital

    Grand Forks, North Dakota, 58201

  • Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center

    Grand Island, Nebraska, 68803

  • Benefis Healthcare - Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Cancer Centers of the Carolinas - Faris Road

    Greenville, South Carolina, 29605

  • Cancer Centers of the Carolinas - Grove Commons

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Butternut

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Faris

    Greenville, South Carolina, 29605

  • Greenville Hospital Cancer Center

    Greenville, South Carolina, 29605

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Cancer Centers of the Carolinas - Greer Medical Oncology

    Greer, South Carolina, 29650

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Illinois CancerCare - Havana

    Havana, Illinois, 62644

  • Geisinger Medical Center-Cancer Center Hazelton

    Hazleton, Pennsylvania, 18201

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Oncare Hawaii Inc-POB II

    Honolulu, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Lusitana

    Honolulu, Hawaii, 96813

  • Queen's Cancer Institute at Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital, Incorporated

    Honolulu, Hawaii, 96813

  • University of Hawaii

    Honolulu, Hawaii, 96813

  • Kuakini Medical Center

    Honolulu, Hawaii, 96817

  • OnCare Hawaii, Incorporated - Kuakini

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • New Hampshire Oncology - Hematology, PA - Hooksett

    Hooksett, New Hampshire, 03106

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • St. Francis Hospital Cancer Care Services

    Indianapolis, Indiana, 46237

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • Castle Medical Center

    Kailua, Hawaii, 96734

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Illinois CancerCare - Kewanee Clinic

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Gundersen Lutheran Center for Cancer and Blood

    La Crosse, Wisconsin, 54601

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • Lakes Region General Hospital

    Laconia, New Hampshire, 03246

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Nevada Cancer Research Foundation CCOP

    Las Vegas, Nevada, 89106

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958

  • Cancer Center of Kansas, PA - Liberal

    Liberal, Kansas, 67901

  • Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Cancer Resource Center - Lincoln

    Lincoln, Nebraska, 68510

  • Nebraska Cancer Research Center

    Lincoln, Nebraska, 68510

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Hope Cancer Care Center at Longmont United Hospital

    Longmont, Colorado, 80501

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Illinois CancerCare - Macomb

    Macomb, Illinois, 61455

  • HealthEast Cancer Care at St. John's Hospital

    Maplewood, Minnesota, 55109

  • Minnesota Oncology - Maplewood

    Maplewood, Minnesota, 55109

  • Mercy Cancer Center at Mercy Medical Center - North Iowa

    Mason City, Iowa, 50401

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537-1839

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Illinois CancerCare - Monmouth

    Monmouth, Illinois, 61462

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital - Monroe

    Monroe, Michigan, 48162

  • Toledo Clinic Cancer Centers-Monroe

    Monroe, Michigan, 48162

  • Mount Kisco Medical Group at Northern Westchester Hospital

    Mount Kisco, New York, 10549

  • Westfields Hospital/Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • Mount Sinai Medical Center

    New York, New York, 10029

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • Illinois CancerCare - Community Cancer Center

    Normal, Illinois, 61761

  • Cancer Care Associates - Norman

    Norman, Oklahoma, 73071

  • Callahan Cancer Center at Great Plains Regional Medical Center

    North Platte, Nebraska, 69103

  • Oconomowoc Memorial Hospital-ProHealth Care Inc

    Oconomowoc, Wisconsin, 53066

  • Regional Cancer Center at Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • Cancer Care Associates - Mercy Campus

    Oklahoma City, Oklahoma, 73120

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegant Health Cancer Center at Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Alegent Health Lakeside Hospital

    Omaha, Nebraska, 68130

  • Lakeside Hospital

    Omaha, Nebraska, 68130

  • Creighton University Medical Center

    Omaha, Nebraska, 68131-2197

  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center

    Omaha, Nebraska, 68198-6805

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic - Oregon

    Oregon, Ohio, 43616

  • Florida Hospital Cancer Institute at Florida Hospital Orlando

    Orlando, Florida, 32803-1273

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Oncology Hematology Associates of Central Illinois, PC - Ottawa

    Ottawa, Illinois, 61350

  • Ottawa Regional Hospital and Healthcare Center

    Ottawa, Illinois, 61350

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Illinois CancerCare - Pekin

    Pekin, Illinois, 61603

  • Proctor Hospital

    Peoria, Illinois, 61614

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • Illinois CancerCare - Peru

    Peru, Illinois, 61354

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • Palchak David MD

    Pismo Beach, California, 93449

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • Saint Joseph Mercy Port Huron

    Port Huron, Michigan, 48060

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Illinois CancerCare - Princeton

    Princeton, Illinois, 61356

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • St. Mary - Corwin Regional Medical Center

    Pueblo, Colorado, 81004

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Reid Hospital & Health Care Services

    Richmond, Indiana, 47374

  • Valley Hospital - Ridgewood

    Ridgewood, New Jersey, 07450

  • Humphrey Cancer Center at North Memorial Outpatient Center

    Robbinsdale, Minnesota, 55422-2900

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan, 48601

  • CentraCare Clinic - River Campus

    Saint Cloud, Minnesota, 56303

  • Coborn Cancer Center

    Saint Cloud, Minnesota, 56303

  • Saint Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Cancer Center

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital Cancer Care Center

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67401

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259-5499

  • Cancer Centers of the Carolinas - Seneca

    Seneca, South Carolina, 29672

  • Greenville Health System Cancer Institute-Seneca

    Seneca, South Carolina, 29672

  • St. Francis Cancer Center at St. Francis Medical Center

    Shakopee, Minnesota, 55379

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa, 51102

  • St. Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Sanford Cancer Center at Sanford USD Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • Cancer Centers of the Carolinas - Spartanburg

    Spartanburg, South Carolina, 29307

  • Greenville Health System Cancer Institute-Spartanburg

    Spartanburg, South Carolina, 29307

  • Illinois CancerCare - Spring Valley

    Spring Valley, Illinois, 61362

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Geisinger Medical Group

    State College, Pennsylvania, 16801

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • Flower Hospital Cancer Center

    Sylvania, Ohio, 43560

  • Mercy Hospital of Tiffin

    Tiffin, Ohio, 44883

  • Toledo Hospital

    Toledo, Ohio, 43606

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Medical University of Ohio Cancer Center

    Toledo, Ohio, 43614

  • University of Toledo

    Toledo, Ohio, 43614

  • St. Anne Mercy Hospital

    Toledo, Ohio, 43623

  • Toledo Clinic Cancer Centers-Toledo

    Toledo, Ohio, 43623

  • Toledo Clinic, Incorporated - Main Clinic

    Toledo, Ohio, 43623

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373-1300

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Legacy Salmon Creek Hospital

    Vancouver, Washington, 98686

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Waukesha Memorial Hospital Regional Cancer Center

    Waukesha, Wisconsin, 53188

  • Fulton County Health Center

    Wauseon, Ohio, 43567

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Precision Radiotherapy at University Pointe

    West Chester, Ohio, 45069

  • Methodist West Hospital

    West Des Moines, Iowa, 50266-7700

  • Mercy Medical Center-West Lakes

    West Des Moines, Iowa, 50266

  • Exempla Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • Associates in Women's Health - Wichita

    Wichita, Kansas, 67208

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas - Main Office

    Wichita, Kansas, 67214

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Willmar Cancer Center at Rice Memorial Hospital

    Willmar, Minnesota, 56201

Other trials in United States

About this study

Official title: Phase I/Randomized Phase II Double Blind Study of Either Dasatinib or Placebo Combined With Bevacizumab in Recurrent Glioblastoma

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also block the growth of the tumor by blocking blood flow to the tumor. It is not yet known whether bevacizumab together with dasatinib are more effective than a placebo in treating patients with recurrent or progressive high-grade glioma or glioblastoma multiforme.

PURPOSE: This randomized phase I/II trial (Phase I completed) is studying the side effects and best dose of dasatinib when given together with bevacizumab and to see how well it works compared to placebo in treating patients with recurrent or progressive high-grade glioma or glioblastoma multiforme.

Read the detailed description

OUTLINE: This is a multicenter, phase I, dose-escalation study (Phase I completed) of dasatinib followed by a phase II randomized study. Patients are grouped according to study (1 vs 2). Patients in the phase II portion are stratified according to age (> 70 years of age vs ≤ 70 years of age), and ECOG performance status (0 vs 1 or 2).

Phase I: Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral dasatinib once or twice daily on days 1-14 until the maximum-tolerated dose (MTD) is determined. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. (Phase I completed) Please see the Arms section for the Phase II treatment regimens.

OBJECTIVES:

PRIMARY OBJECTIVES:

  1. Determine the maximum tolerated dose (MTD) of dasatinib in combination with bevacizumab in high grade glioma patients. (Phase I)
  2. To assess the safety and adverse events of the dasatinib in combination with bevacizumab in this patient population. (Phase I)
  3. To estimate the efficacy of the bevacizumab combination with dasatinib in recurrent glioblastoma multiforme as measured by progression free survival at six months and compare it with the efficacy of bevacizumab alone. (Phase II)

SECONDARY OBJECTIVES:

  1. To describe the overall toxicity associated with the dasatinib/bevacizumab combination. (Phase I)
  2. To describe any preliminary evidence of antitumor activity. (Phase I)
  3. To assess the time to disease progression. (Phase II)
  4. To assess the safety and toxicity of the bevacizumab combination with dasatinib in this patient population. (Phase II)
  5. To estimate the efficacy of the bevacizumab combination with dasatinib in recurrent glioblastoma multiforme as measured by overall survival time and compare it with the efficacy of bevacizumab alone. (Phase II)
  6. To assess the impact of the treatment on the patient's quality of life (QOL) using the overall score from the FACT-Br (Phase II)
Being tested
bevacizumab, dasatinib, placebo
Keywords
adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma, adult mixed glioma, recurrent adult brain tumor, adult anaplastic oligodendroglioma, adult oligodendroglioma, adult anaplastic astrocytoma
Medical subject headings
Glioblastoma, Gliosarcoma, Glioma, Brain Neoplasms, Oligodendroglioma, Astrocytoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00892177
Study groupRoleWhat they receive
Arm IExperimentalPatients receive bevacizumab on Day 1 and dasatinib on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Receives: Biological: bevacizumab; Drug: dasatinib
Arm IIActive comparatorPatients receive bevacizumab on Day 1 and placebo on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Receives: Biological: bevacizumab; Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Dasatinib in Combination With Bevacizumab (Phase I)

    The Maximum Tolerated Dose (MTD) will be based on the assessment of dose-limiting toxicities (DLT) during the first 4 weeks of treatment only (i.e., following the first 2 treatment cycles), and will be defined as the dose at which fewer than one-third of patients experience a DLT to study treatment. The MTD is the dose level at which 0/6 or 1/6 patients experience DLT with the next higher dose having at least 2 out of 3 or 2 out of 6 patients encountering DLT.> Three patients will be treated at each dose level, and can be enrolled simultaneously. If one DLT is encountered, an additional 3 patients will be added to that dose level. If at any point two DLTs are encountered within a given dose level, then the MTD has been exceeded and if only three patients have been treated at the next lower dose three more patients are treated at the next lower dose. The number of patients who developed DLTs are reported here by dose level, with the MTD reported in the statistical analysis section.

    Measured: 14 days

  2. Progression-free Survival at 6 Months (PFS6) (Phase II)

    The primary endpoint is the proportion of patients alive and progression-free 6 months after study treatment initiation (PFS6). All eligible consented patients that received treatment will be considered evaluable. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred. PFS6 is defined as the time from start of study therapy to the date of first observation of disease progression or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The PFS6 will be estimated as the number of evaluable patients progression free and still alive at 6 months divided by the total number of evaluable patients. The confidence interval will be calculated according to the Clopper-Pearson Method.

    Measured: 6 months

Secondary outcomes (5)

  1. Number of Participants With Adverse Events According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 (Phase II)

    Adverse events were collected systematically at the end of each cycle and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0. Events are scored as: 1="Mild symptoms", 2= "Moderate", 3="Severe", 4="Life-threatening", and 5="Death". The number of patients reporting a grade 3 or higher event regardless of attribution are summarized here. A complete list of all adverse events reported during treatment can be found in the Adverse Events Section.

    Measured: Up to 3 years

  2. Overall Survival (Phase II)

    Survival time is defined to be the length of time from start of study therapy to death due to any cause. All patients meeting the eligibility criteria that have signed a consent form and begun treatment will be considered evaluable for estimation of the survival distribution. The distribution of overall survival for both arms of the study will be estimated using the Kaplan-Meier method, and be compared using log-rank tests.

    Measured: Up to 3 years

  3. Time-to-disease Progression (Phase II)

    Time-to-disease progression is defined as the time from start of study therapy to documentation of disease progression. Patients who die without documentation of progression will be considered to have had tumor progression at the time of death unless there is documented evidence that no progression occurred before death. Patients who fail to return for evaluation after beginning therapy will be censored for progression on the last day of therapy or date last known to be alive, whichever is later. Patients who are still alive and have not progressed will be censored for progression at the time of the last tumor assessment. Patients who experience major treatment violations will be censored for progression on the date the treatment violation occurred. The time-to-progression distribution will be estimated using the Kaplan-Meier method.

    Measured: Up to 3 years

  4. Patient-reported QOL, as Measure by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) (Phase II)

    FACT-Br questionnaires were used to assess QOL at every other cycle of treatment (prior to cycles 3, 5, 7, etc.). FACT-Br includes 50 questions used to assess patients' self-assessment in 4 broad categories: Physical, Social/Family, Emotional, and Function Well-being. Scores range from 0="Not at all", 1="A little bit", 2="Somewhat", 3="Quite a bit", 4="Very Much". Higher scores can be interpreted as having higher quality of life. The scores for all 50 questions were summed to give a total score per patient per cycle. Therefore the possible range is from 0 to 200. Below is the reported mean and standard deviation for patients at baseline and during cycles 2, 4, 6, 8, and 10.

    Measured: Baseline to cycle 10 (20 weeks).

  5. Objective Response (Phase II)

    Objective response to treatment will be determined by the results of neurological exam and the MRI and/or CT measurement of the tumor at each evaluation as is used for all NCCTG neuro-oncology trials. The percentage of patients in each response category will be summarized, 95% confidence intervals calculated, and rates between the 2 arms will be compared using a Fisher's Exact test. For bi-dimensionally measurable disease, CR: total disappearance of all tumor and that patients be on no corticosteroids or on only adrenal replacement maintenance; PR: ≥ 50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions, and stable or decreasing steroid dosing; PD: >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions; REGR: unequivocal reduction in extent of contrast-enhancement, or a decrease in mass effect, no new lesions (for evaluable disease); SD: failure to qualify for CR, PR,REGR or PD.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionNov 2014
  4. Study completion1 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00892177
Sponsor's protocol ID
NCCTG-N0872
Other IDs
NCI-2011-01921, CDR0000641746
Status last verified
Oct 2019
First submitted
1 May 2009
Last updated
21 Oct 2019
Data monitoring committee
Yes

Publications

  • Galanis E, Anderson SK, Twohy EL, Carrero XW, Dixon JG, Tran DD, Jeyapalan SA, Anderson DM, Kaufmann TJ, Feathers RW, Giannini C, Buckner JC, Anastasiadis PZ, Schiff D. A phase 1 and randomized, placebo-controlled phase 2 trial of bevacizumab plus dasatinib in patients with recurrent glioblastoma: Alliance/North Central Cancer Treatment Group N0872. Cancer. 2019 Nov 1;125(21):3790-3800. doi: 10.1002/cncr.32340. Epub 2019 Jul 10.

    PubMed 31290996

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab and dasatinib in people with Glioblastoma Multiforme, run by Alliance for Clinical Trials in Oncology at 305 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 305 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Dasatinib in Combination With Bevacizumab (Phase I) (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00892177, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.

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