AzTrials
AzTrials

Brain and Central Nervous System TumorsPhase 1/2NCT00869401

Dasatinib or Placebo, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

A Phase 1/2 study testing dasatinib, temozolomide and radiation therapy in people with Brain and Central Nervous System Tumors, run by Alliance for Clinical Trials in Oncology at 207 sites in United States.

Completed

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

Official record
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Trial summary

Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also make tumor cells more sensitive to radiation therapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
dasatinib, temozolomide and radiation therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
217 participants
Where
207 sitesUnited States
Study dates
Jun 2009to 15 Nov 2019
Phase
Phase 1/2
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

Pre-registration Inclusion Criteria:

  1. Central Pathology Review - Central pathology review submission. This review is mandatory prior to registration to confirm eligibility.

Registration Inclusion Criteria:

  1. Age ≥ 18 years
  2. Histological Confirmation of Glioblastoma - Histologically confirmed newly diagnosed glioblastoma (GBM) (grade 4 astrocytoma) as determined by pre-registration central pathology review. Note: GBM with oligodendroglial features are not permitted in this study if they are 1p19q codeleted. Sites submitting GBM with oligodendroglial features will be asked to provide results of 1p/19q codeletion status.
  3. Measurable or Evaluable Disease - Measurable or evaluable disease by gadolinium MRI or contrast CT scan. Note: Patients who have had a gross total resection are eligible on the basis of evaluable disease.
  4. ECOG Performance Status 0, 1 or 2.
  5. Required Laboratory Values: The following laboratory values obtained ≤ 14 days prior to registration.
  • Absolute neutrophil count (ANC) ≥ 1500/mm3
  • Platelet count ≥ 100,000/mm3
  • Hemoglobin > 9.0 g/dL
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
  • SGOT (AST) ≤ 2.5 x ULN
  • Creatinine ≤ 1.5 x ULN
  1. Required INR Value: The following INR value obtained ≤ 28 days prior to registration
  • INR ≤ 1.5
  1. Urine or Serum Pregnancy Test - Negative urine or serum pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
  2. Written Informed Consent - Patient must provide written informed consent.
  3. Return to Enrolling Institution - Patient must be willing to return to Alliance enrolling institution for follow-up.
  4. Tissue Samples - Patient must be willing to provide tissue samples for research purposes.
  5. Patient must be willing to provide tissue samples for research purposes.
  6. Required Antibiotic Prophylaxis - Patient must be willing to comply with antibiotic prophylaxis with trimethoprim/sulfamethoxazole, pentamidine or dapsone.
  7. Grapefruit and Grapefruit Juice - Patient must be willing to abstain from eating grapefruit or drinking grapefruit juice for the duration of the study treatment.
  8. Ability to Swallow - Patient must have the ability to take oral medication (dasatinib must be swallowed whole).
  9. Quality of Life (QOL) Questionnaires - Phase II patients only: Patients must be willing and able to complete QOL questionnaires independently or with the help of a caregiver.
  10. Other Anti-Tumor Drug Therapies - Patient must be willing to forego other cytotoxic and non-cytotoxic drug therapy against the tumor while being treated with dasatinib and temozolomide.

Registration Exclusion Criteria:

  1. Pregnancy, Nursing and Required Contraception - Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception throughout study treatment and for at least 12 weeks after study drug is stopped.
  1. Prior Radiotherapy or Chemotherapy for Any CNS Neoplasm - Received any prior radiotherapy or chemotherapy for any CNS neoplasm (hormones, vitamins and growth factors are not considered chemotherapy for the purposes of this study.
  2. Prior Surgery for Any CNS Neoplasm - Prior surgeries for any CNS neoplasms, other than surgery related to the current GBM diagnosis. Note: If Gliadel wafers are placed at time of primary resection, this would be considered prior therapy and patient would be ineligible.
  3. Concurrent Illness or Disease - 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. Including but not limited to:
  • History of bleeding diathesis
  • Current use of chronic systemic anticoagulation therapy that cannot be discontinued (antiplatelet agents, Aspirin)
  • Current chronic use of NSAIDs which cannot be discontinued
  1. Pleural or Pericardial Effusions - Pleural or pericardial effusion of any grade.
  2. Immunocompromised Status - Immunocompromised patients (other than that related to the use of corticosteroids) and patients known to be HIV positive and currently receiving antiretroviral therapy. Note: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
  3. Uncontrolled Intercurrent Illness - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  4. Other Investigational Agents - Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
  5. Other Active Malignancies - Other active malignancy ≤ 5 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.
  6. History of Cardiac or Metabolic Conditions:
  • Myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
  • Diagnosed congenital long QT syndrome
  • Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
  • Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec)
  • Patients with hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration.
  1. Clinically Significant Cardiovascular Disease - Patients may not have any clinically significant cardiovascular disease including the following:
  • Myocardial infarction or ventricular tachyarrhythmia within 6 months.
  • 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 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. Congestive Heart Failure - New York Heart Association classification ≥ Class II Congestive Heart Failure.
  2. Prohibited or Restricted Concomitant Treatments - Currently taking one of the following medications:
  • Enzyme inducing anti-convulsants (EIACs) Note: To be eligible, patient must be switched to non-EIAC medications ≥7 days prior to registration. See protocol for a list of EIAC and non-EIAC medications.
  • Potent inhibitors of CYP3A4 which cannot be discontinued. See protocol for a list of medications known to inhibit CYP3A4.
  • Medications known to prolong QT interval which cannot be discontinued or switched. See Appendix II for a list of medications which are known to prolong the QT interval.
  • Medications that may possibly prolong QT interval and produce a QTc that is ≥ 60 msec or a QTcF that is ≥ 450 msec. See Appendix II for a list of medications that may possibly prolong QTc.
  • St. John's Wort
  • H2 blockers or proton pump inhibitors (PPIs), such as famotidine (Pepcid) and omeprazole (Prilosec) respectively, which cannot be discontinued or switched to locally acting agents, such as Maalox, Mylanta and TUMS.
  1. Allergy to Antibiotic Prophylaxis Medications - Severe allergy to sulfa medications and dapsone and pentamidine.

Trial locations and contacts

207 sites in 1 country.

207 sites in 1 country

United States207 sites

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87131-5636

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • MeritCare Bemidji

    Bemidji, Minnesota, 56601

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59102

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Medcenter One Hospital Cancer Care Center

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center Cancer Center

    Bismarck, North Dakota, 58502

  • Illinois CancerCare - Bloomington

    Bloomington, Illinois, 61701

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Illinois CancerCare - Canton

    Canton, Illinois, 61520

  • Illinois CancerCare - Carthage

    Carthage, Illinois, 62321

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa, 52403

  • Mercy Regional Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Resurrection Medical Center

    Chicago, Illinois, 60631

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Medical Oncology and Hematology Associates - West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center - West Lakes

    Clive, Iowa, 50325

  • John B. Amos Cancer Center

    Columbus, Georgia, 31904

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Medical Center Cancer Care

    Columbus, Ohio, 43215

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

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

    Concord, New Hampshire, 03301

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • 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

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • 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

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Essentia Health - Duluth Clinic

    Duluth, Minnesota, 55805-1983

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller - Dwan Medical Center

    Duluth, Minnesota, 55805

  • Cancer Centers of the Carolinas - Easley

    Easley, South Carolina, 29640

  • CCOP - Hematology-Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • Center for Cancer Treatment & Prevention at Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Marshfield Clinic Cancer Care at Regional Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Elkhart Clinic, LLC

    Elkhart, Indiana, 46514-2098

  • Michiana Hematology-Oncology, PC - Elkhart

    Elkhart, Indiana, 46514

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Community Cancer Center

    Elyria, Ohio, 44035

  • Hematology Oncology Center

    Elyria, Ohio, 44035

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • Illinois CancerCare - Eureka

    Eureka, Illinois, 61530

  • MeritCare Broadway

    Fargo, North Dakota, 58102

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Central Wisconsin Cancer Program at Agnesian HealthCare

    Fond du Lac, Wisconsin, 54935

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • 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

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • 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 Hospital Cancer Center

    Greenville, South Carolina, 29605

  • Cancer Centers of the Carolinas - Eastside

    Greenville, South Carolina, 29615

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Cancer Centers of the Carolinas - Greer Medical Oncology

    Greer, South Carolina, 29650

  • Cancer Centers of the Carolinas - Greer Radiation Oncology

    Greer, South Carolina, 29650

  • Helen and Harry Gray Cancer Center at Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • Illinois CancerCare - Havana

    Havana, Illinois, 62644

  • St. Peter's Hospital

    Helena, Montana, 59601

  • 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

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • 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

  • Howard Community Hospital

    Kokomo, Indiana, 46904

  • Gundersen Lutheran Center for Cancer and Blood

    La Crosse, Wisconsin, 54601

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Lakes Region General Hospital

    Laconia, New Hampshire, 03246

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Cancer Center of Kansas, PA - Liberal

    Liberal, Kansas, 67901

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Illinois CancerCare - Macomb

    Macomb, Illinois, 61455

  • HealthEast Cancer Care at St. John's Hospital

    Maplewood, Minnesota, 55109

  • Minnesota Oncology - Maplewood

    Maplewood, Minnesota, 55109

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • Saint Joseph's Hospital

    Marshfield, Wisconsin, 54449

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537-1839

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Marshfield Clinic - Lakeland Center

    Minocqua, Wisconsin, 54548

  • Michiana Hematology-Oncology, PC - South Bend

    Mishawaka, Indiana, 46545-1470

  • Saint Joseph Regional Medical Center

    Mishawaka, Indiana, 46545-1470

  • 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

  • OSF Holy Family Medical Center

    Monmouth, Illinois, 61462

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital - Monroe

    Monroe, Michigan, 48162

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

  • 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

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic - Oregon

    Oregon, Ohio, 43616

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • Oncology Hematology Associates of Central Illinois, PC - Ottawa

    Ottawa, Illinois, 61350

  • 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

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61615-7827

  • 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

  • Michiana Hematology Oncology PC - Plymouth

    Plymouth, Indiana, 46563

  • Southern Ohio Medical Center Cancer Center

    Portsmouth, Ohio, 45662

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Illinois CancerCare - Princeton

    Princeton, Illinois, 61356

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Ministry Medical Group at Saint Mary's Hospital

    Rhinelander, Wisconsin, 54501

  • Marshfield Clinic - Indianhead Center

    Rice Lake, Wisconsin, 54868

  • Reid Hospital & Health Care Services

    Richmond, Indiana, 47374

  • Humphrey Cancer Center at North Memorial Outpatient Center

    Robbinsdale, Minnesota, 55422-2900

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • CentraCare Clinic - River Campus

    Saint Cloud, Minnesota, 56303

  • Coborn Cancer Center

    Saint Cloud, Minnesota, 56303

  • Lakeland Regional Cancer Care Center - St. Joseph

    Saint Joseph, Michigan, 49085

  • Lakeside Cancer Specialists, PLLC

    Saint Joseph, Michigan, 49085

  • 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, PA - Salina

    Salina, Kansas, 67401

  • Cancer Centers of the Carolinas - 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

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Sanford Cancer Center at Sanford USD Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Cancer Centers of the Carolinas - Spartanburg

    Spartanburg, South Carolina, 29307

  • Illinois CancerCare - Spring Valley

    Spring Valley, Illinois, 61362

  • Valley Cancer Center

    Spring Valley, Illinois, 61362

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio, 45505

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

    St Louis, Missouri, 63110

  • Marshfield Clinic at Saint Michael's Hospital

    Stevens Point, Wisconsin, 54481

  • Saint Michael's Hospital Cancer Center

    Stevens Point, Wisconsin, 54481

  • 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

  • St. Anne Mercy Hospital

    Toledo, Ohio, 43623

  • Toledo Clinic, Incorporated - Main Clinic

    Toledo, Ohio, 43623

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373-1300

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma, 74136

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Fulton County Health Center

    Wauseon, Ohio, 43567

  • 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

  • Mount Carmel St. Ann's Cancer Center

    Westerville, Ohio, 43081

  • Marshfield Clinic - Weston Center

    Weston, Wisconsin, 54476

  • Michiana Hematology Oncology PC - La Porte

    Westville, Indiana, 46391

  • 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, 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

  • Willmar Cancer Center at Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

  • Minnesota Oncology - Woodbury

    Woodbury, Minnesota, 55125

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio, 45385

  • Genesis - Good Samaritan Hospital

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: Phase I/Randomized Phase II Trial of Either Dasatinib or Placebo Combined With Standard Chemo-Radiotherapy for Newly Diagnosed Glioblastoma Multiforme (GBM)

Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also make tumor cells more sensitive to radiation therapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. This randomized phase I/II trial is studying the best dose of dasatinib and to see how well it works compared with a placebo when given together with radiation therapy and temozolomide in treating patients with newly diagnosed glioblastoma multiforme.

Read the detailed description

This trial includes a phase I dose-escalation study and a double-blind randomized phase II trial for patients with newly diagnosed glioblastoma multiforme (GBM). Phase I will be a cohort of 3 dose-escalation trial of dasatinib in combination with radiation and concomitant temozolomide. Patients receive concomitant chemotherapy and radiation therapy for cycle one. Patients receive adjuvant chemotherapy 28-42 days post cycle one treatment. Patients receive only dasatinib post cycle 8 treatment until progressive disease, unacceptable adverse events or refusal.

Phase II will be a randomized trial with two treatment arms. Patients will be randomized at the time of registration at a ratio of 1:2 respectively to either standard therapy arm (continuous daily placebo prior, during and after standard radiotherapy/temozolomide followed by temozolomide. For more information please see the Arms section. The primary objectives are listed below.

Primary Objectives:

  1. To establish a maximum tolerated dose of dasatinib combined with radiation and temozolomide in this patient population (Phase I)
  2. To determine the efficacy of dasatinib in combination with radiotherapy and concomitant and adjuvant temozolomide in patients with newly diagnosed glioblastoma, and compare it with the standard of care approach in the treatment of these patients consisting of radiotherapy and temozolomide, followed by adjuvant temozolomide (Phase II)

Patients are followed for 5 years post treatment. The study permanently closed to accrual on January 31, 2014.

Being tested
dasatinib, temozolomide, placebo, radiation therapy
Keywords
adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma
Medical subject headings
Central Nervous System Neoplasms, Glioblastoma, Gliosarcoma

What participants receive

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

  • dasatinibDrug

    Given orally

  • temozolomideDrug

    Given orally

  • placeboOther

    Given orally

  • radiation therapyRadiation

    Radiation therapy is performed as 30 fractions of 200 cGy for a total of 6000 cGy.

Study groups in NCT00869401
Study groupRoleWhat they receive
Group 1 (Phase II) dasatinib + radiation + temozolomideExperimentalPatients receive concomitant chemotherapy and radiation for cycle one for a total of 42 days, then patients receive adjuvant chemotherapy 28-42 days post cycle one treatment. Patients receive only dasatinib post cycle 8 until progressive disease, unacceptable adverse events or refusal.
Receives: Drug: dasatinib; Drug: temozolomide; Radiation: radiation therapy
Group 2 (Phase II) placebo + radiation + temozolomideActive comparatorPatients receive concomitant chemotherapy and radiation for cycle one for a total of 42 days, then patients receive adjuvant chemotherapy 28-42 days post cycle one treatment. Patients receive only placebo post cycle 8 until progressive disease, unacceptable adverse events or refusal.
Receives: Drug: temozolomide; Other: placebo; Radiation: radiation therapy

What is being measured

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

  1. Overall Survival

    Overall survival (OS) is the primary endpoint and is defined as the time from study registration to time of death due to any cause. All patients who meet the eligibility criteria, have signed a consent form, and have received at least one dose of the regimens will be considered evaluable. Patients who are lost to follow-up will be censored at the date of their last follow-up. Patients still alive at the time of analysis will be censored. Only Phase II was evaluated for survival

    Measured: Up to 5 years post treatment

  2. The Number of Dose Limiting Toxicities(DLT) in Order to Determine Maximum Tolerable Dose(MTD) of Dasatinib Combined With Radiation and Temozolomide in This Patient Population.

    Doselimiting toxicity will be defined as: Adverse event at least possibly related to the study medication. All by CTCAE v3.0 criteria: Greater than or equal to grade 3: diarrhea or skin rash or desquamation or (other) clinically relevant non-hematological adverse event or non-hematologic adverse event at least possibly due to drug therapy. Or greater than or equal to grade 4: neutropenia or leukopenia or thrombocytopenia or radiation dermatitis or hematologic adverse event OR failure to administer greater than 75% of dasatinib TMZ or interruption of RT for more than 5 days due to adverse events.OR severe acute central nervous system deterioration attributable to TMZ, RT and or dasatinib which cannot be controlled with corticosteroid administration. The MTD for this study will be defined as the highest safely tolerated dose level where at most 1 out of 6 patients experience DLT with the next higher dose having at least 2 patients out of a maximum of 6 patients experience DLT.

    Measured: Every cycle from first dose to end of rest period prior cycle 3

Secondary outcomes (2)

  1. Progression-free Survival

    Progression-free survival (PFS) is defined as the time from study registration to the date of first observation of disease progression or death due to any cause (whichever comes first). If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Only Phase II patients were evaluated for Progression-free survival

    Measured: Up to 5 years post treatment

  2. Objective Response

    Objective response to treatment will be determined by a combination of 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 proportion of patients in each response category will be summarized. Only phase II patients were evaluated for response.

    Measured: Up to 5 years post treatment

Timeline

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

  1. First posted26 Mar 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionOct 2014
  4. Study completion15 Nov 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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00869401
Sponsor's protocol ID
NCCTG-N0877
Other IDs
NCI-2009-01179, CDR0000637854, U10CA025224
Status last verified
Feb 2020
First submitted
25 Mar 2009
Last updated
13 Feb 2020
Data monitoring committee
Yes

Publications

  • Breen WG, Dixon JG, Anderson SK, Sarkaria JN, Brown PD, Yan ES, Kizilbash S, Galanis E, Anderson D, Tran D, Mazurczak M, Johnson DR, Geoffroy FJ, Leinweber C, Laack NN. Final report on North Central Cancer Treatment Group N0877 (alliance): A phase II randomized, placebo-controlled trial of chemoradiotherapy with or without dasatinib for glioblastoma. Neuro Oncol. 2025 Oct 1;27(10):2661-2670. doi: 10.1093/neuonc/noaf156.

    PubMed 40579995

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing dasatinib, temozolomide and radiation therapy in people with Brain and Central Nervous System Tumors, run by Alliance for Clinical Trials in Oncology at 207 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 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 207 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 8 May 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?

Overall Survival (time frame: Up to 5 years post treatment). 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 NCT00869401, 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 13 Feb 2020.

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