NCT00869401

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_1

Geographic Reach
1 country

207 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

May 8, 2017

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2019

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

5.3 years

First QC Date

March 25, 2009

Results QC Date

December 12, 2016

Last Update Submit

February 4, 2020

Conditions

Keywords

adult giant cell glioblastomaadult glioblastomaadult gliosarcoma

Outcome Measures

Primary Outcomes (2)

  • 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

    Up to 5 years post treatment

  • 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.

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

Secondary Outcomes (2)

  • Progression-free Survival

    Up to 5 years post treatment

  • Objective Response

    Up to 5 years post treatment

Study Arms (2)

Group 1 (Phase II) dasatinib + radiation + temozolomide

EXPERIMENTAL

Patients 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.

Drug: dasatinibDrug: temozolomideRadiation: radiation therapy

Group 2 (Phase II) placebo + radiation + temozolomide

ACTIVE COMPARATOR

Patients 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.

Drug: temozolomideOther: placeboRadiation: radiation therapy

Interventions

Given orally

Group 1 (Phase II) dasatinib + radiation + temozolomide

Given orally

Group 1 (Phase II) dasatinib + radiation + temozolomideGroup 2 (Phase II) placebo + radiation + temozolomide
placeboOTHER

Given orally

Group 2 (Phase II) placebo + radiation + temozolomide

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

Group 1 (Phase II) dasatinib + radiation + temozolomideGroup 2 (Phase II) placebo + radiation + temozolomide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Central Pathology Review - Central pathology review submission. This review is mandatory prior to registration to confirm eligibility.
  • Age ≥ 18 years
  • 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.
  • 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.
  • ECOG Performance Status 0, 1 or 2.
  • 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
  • Required INR Value: The following INR value obtained ≤ 28 days prior to registration
  • INR ≤ 1.5
  • +10 more criteria

You may not qualify if:

  • 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.
  • 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.
  • 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.
  • 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
  • Pleural or Pericardial Effusions - Pleural or pericardial effusion of any grade.
  • 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.
  • 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.
  • Other Investigational Agents - Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
  • Other Active Malignancies - Other active malignancy ≤ 5 years prior to registration.
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (207)

Helen and Harry Gray Cancer Center at Hartford Hospital

Hartford, Connecticut, 06102-5037, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

John B. Amos Cancer Center

Columbus, Georgia, 31904, United States

Location

Illinois CancerCare - Bloomington

Bloomington, Illinois, 61701, United States

Location

St. Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Illinois CancerCare - Canton

Canton, Illinois, 61520, United States

Location

Illinois CancerCare - Carthage

Carthage, Illinois, 62321, United States

Location

Resurrection Medical Center

Chicago, Illinois, 60631, United States

Location

Eureka Community Hospital

Eureka, Illinois, 61530, United States

Location

Illinois CancerCare - Eureka

Eureka, Illinois, 61530, United States

Location

Galesburg Clinic, PC

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare - Havana

Havana, Illinois, 62644, United States

Location

Illinois CancerCare - Kewanee Clinic

Kewanee, Illinois, 61443, United States

Location

Illinois CancerCare - Macomb

Macomb, Illinois, 61455, United States

Location

Illinois CancerCare - Monmouth

Monmouth, Illinois, 61462, United States

Location

OSF Holy Family Medical Center

Monmouth, Illinois, 61462, United States

Location

BroMenn Regional Medical Center

Normal, Illinois, 61761, United States

Location

Community Cancer Center

Normal, Illinois, 61761, United States

Location

Illinois CancerCare - Community Cancer Center

Normal, Illinois, 61761, United States

Location

Community Hospital of Ottawa

Ottawa, Illinois, 61350, United States

Location

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, 61350, United States

Location

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, 61554, United States

Location

Illinois CancerCare - Pekin

Pekin, Illinois, 61603, United States

Location

Proctor Hospital

Peoria, Illinois, 61614, United States

Location

OSF St. Francis Medical Center

Peoria, Illinois, 61615-7827, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61615, United States

Location

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, 61615, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

Illinois CancerCare - Peru

Peru, Illinois, 61354, United States

Location

Illinois Valley Community Hospital

Peru, Illinois, 61354, United States

Location

Illinois CancerCare - Princeton

Princeton, Illinois, 61356, United States

Location

Illinois CancerCare - Spring Valley

Spring Valley, Illinois, 61362, United States

Location

Valley Cancer Center

Spring Valley, Illinois, 61362, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Elkhart Clinic, LLC

Elkhart, Indiana, 46514-2098, United States

Location

Michiana Hematology-Oncology, PC - Elkhart

Elkhart, Indiana, 46514, United States

Location

Elkhart General Hospital

Elkhart, Indiana, 46515, United States

Location

St. Francis Hospital Cancer Care Services

Indianapolis, Indiana, 46237, United States

Location

Howard Community Hospital

Kokomo, Indiana, 46904, United States

Location

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, 46350, United States

Location

Michiana Hematology-Oncology, PC - South Bend

Mishawaka, Indiana, 46545-1470, United States

Location

Saint Joseph Regional Medical Center

Mishawaka, Indiana, 46545-1470, United States

Location

Michiana Hematology Oncology PC - Plymouth

Plymouth, Indiana, 46563, United States

Location

Reid Hospital & Health Care Services

Richmond, Indiana, 47374, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Michiana Hematology Oncology PC - La Porte

Westville, Indiana, 46391, United States

Location

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, 52403, United States

Location

Mercy Regional Cancer Center at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

Location

Medical Oncology and Hematology Associates - West Des Moines

Clive, Iowa, 50325, United States

Location

Mercy Cancer Center - West Lakes

Clive, Iowa, 50325, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309, United States

Location

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates at John Stoddard Cancer Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates at Mercy Cancer Center

Des Moines, Iowa, 50314, United States

Location

Mercy Cancer Center at Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

John Stoddard Cancer Center at Iowa Lutheran Hospital

Des Moines, Iowa, 50316, United States

Location

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, 51101, United States

Location

Mercy Medical Center - Sioux City

Sioux City, Iowa, 51102, United States

Location

St. Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States

Location

Methodist West Hospital

West Des Moines, Iowa, 50266-7700, United States

Location

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, 66701, United States

Location

Cancer Center of Kansas-Independence

Independence, Kansas, 67301, United States

Location

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, 67068, United States

Location

Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States

Location

Cancer Center of Kansas, PA - Liberal

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, PA - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, PA - Salina

Salina, Kansas, 67401, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, PA - North Review

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Hickman Cancer Center at Bixby Medical Center

Adrian, Michigan, 49221, United States

Location

Community Cancer Center of Monroe

Monroe, Michigan, 48162, United States

Location

Mercy Memorial Hospital - Monroe

Monroe, Michigan, 48162, United States

Location

Lakeland Regional Cancer Care Center - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Lakeside Cancer Specialists, PLLC

Saint Joseph, Michigan, 49085, United States

Location

MeritCare Bemidji

Bemidji, Minnesota, 56601, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Essentia Health - Duluth Clinic

Duluth, Minnesota, 55805-1983, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Miller - Dwan Medical Center

Duluth, Minnesota, 55805, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Hutchinson Area Health Care

Hutchinson, Minnesota, 55350, United States

Location

HealthEast Cancer Care at St. John's Hospital

Maplewood, Minnesota, 55109, United States

Location

Minnesota Oncology - Maplewood

Maplewood, Minnesota, 55109, United States

Location

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hennepin County Medical Center - Minneapolis

Minneapolis, Minnesota, 55415, United States

Location

Humphrey Cancer Center at North Memorial Outpatient Center

Robbinsdale, Minnesota, 55422-2900, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Clinic - River Campus

Saint Cloud, Minnesota, 56303, United States

Location

Coborn Cancer Center

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Park Nicollet Cancer Center

Saint Louis Park, Minnesota, 55416, United States

Location

Regions Hospital Cancer Care Center

Saint Paul, Minnesota, 55101, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

St. Francis Cancer Center at St. Francis Medical Center

Shakopee, Minnesota, 55379, United States

Location

Lakeview Hospital

Stillwater, Minnesota, 55082, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Willmar Cancer Center at Rice Memorial Hospital

Willmar, Minnesota, 56201, United States

Location

Minnesota Oncology - Woodbury

Woodbury, Minnesota, 55125, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare Cancer Care Services

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, 59102, United States

Location

Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Bozeman Deaconess Cancer Center

Bozeman, Montana, 59715, United States

Location

St. James Healthcare Cancer Care

Butte, Montana, 59701, United States

Location

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

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

Missoula, Montana, 59807, United States

Location

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

Concord, New Hampshire, 03301, United States

Location

New Hampshire Oncology - Hematology, PA - Hooksett

Hooksett, New Hampshire, 03106, United States

Location

Lakes Region General Hospital

Laconia, New Hampshire, 03246, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131-5636, United States

Location

CCOP - Hematology-Oncology Associates of Central New York

East Syracuse, New York, 13057, United States

Location

Mission Hospitals - Memorial Campus

Asheville, North Carolina, 28801, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Medcenter One Hospital Cancer Care Center

Bismarck, North Dakota, 58501, United States

Location

Mid Dakota Clinic, PC

Bismarck, North Dakota, 58501, United States

Location

St. Alexius Medical Center Cancer Center

Bismarck, North Dakota, 58502, United States

Location

MeritCare Broadway

Fargo, North Dakota, 58102, United States

Location

Altru Cancer Center at Altru Hospital

Grand Forks, North Dakota, 58201, United States

Location

Wood County Oncology Center

Bowling Green, Ohio, 43402, United States

Location

Adena Regional Medical Center

Chillicothe, Ohio, 45601, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267, United States

Location

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, 43214-3998, United States

Location

CCOP - Columbus

Columbus, Ohio, 43215, United States

Location

Grant Medical Center Cancer Care

Columbus, Ohio, 43215, United States

Location

Mount Carmel Health - West Hospital

Columbus, Ohio, 43222, United States

Location

Doctors Hospital at Ohio Health

Columbus, Ohio, 43228, United States

Location

Grandview Hospital

Dayton, Ohio, 45405, United States

Location

Good Samaritan Hospital

Dayton, Ohio, 45406, United States

Location

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Samaritan North Cancer Care Center

Dayton, Ohio, 45415, United States

Location

CCOP - Dayton

Dayton, Ohio, 45420, United States

Location

Grady Memorial Hospital

Delaware, Ohio, 43015, United States

Location

Community Cancer Center

Elyria, Ohio, 44035, United States

Location

Hematology Oncology Center

Elyria, Ohio, 44035, United States

Location

Blanchard Valley Medical Associates

Findlay, Ohio, 45840, United States

Location

Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States

Location

Wayne Hospital

Greenville, Ohio, 45331, United States

Location

Charles F. Kettering Memorial Hospital

Kettering, Ohio, 45429, United States

Location

Fairfield Medical Center

Lancaster, Ohio, 43130, United States

Location

Lima Memorial Hospital

Lima, Ohio, 45804, United States

Location

Strecker Cancer Center at Marietta Memorial Hospital

Marietta, Ohio, 45750, United States

Location

Northwest Ohio Oncology Center

Maumee, Ohio, 43537-1839, United States

Location

Knox Community Hospital

Mount Vernon, Ohio, 43050, United States

Location

Licking Memorial Cancer Care Program at Licking Memorial Hospital

Newark, Ohio, 43055, United States

Location

St. Charles Mercy Hospital

Oregon, Ohio, 43616, United States

Location

Toledo Clinic - Oregon

Oregon, Ohio, 43616, United States

Location

Southern Ohio Medical Center Cancer Center

Portsmouth, Ohio, 45662, United States

Location

Community Hospital of Springfield and Clark County

Springfield, Ohio, 45505, United States

Location

Flower Hospital Cancer Center

Sylvania, Ohio, 43560, United States

Location

Mercy Hospital of Tiffin

Tiffin, Ohio, 44883, United States

Location

Toledo Hospital

Toledo, Ohio, 43606, United States

Location

St. Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

Medical University of Ohio Cancer Center

Toledo, Ohio, 43614, United States

Location

St. Anne Mercy Hospital

Toledo, Ohio, 43623, United States

Location

Toledo Clinic, Incorporated - Main Clinic

Toledo, Ohio, 43623, United States

Location

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, 45373-1300, United States

Location

Fulton County Health Center

Wauseon, Ohio, 43567, United States

Location

Precision Radiotherapy at University Pointe

West Chester, Ohio, 45069, United States

Location

Mount Carmel St. Ann's Cancer Center

Westerville, Ohio, 43081, United States

Location

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, 45385, United States

Location

Genesis - Good Samaritan Hospital

Zanesville, Ohio, 43701, United States

Location

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Tulsa, Oklahoma, 74136, United States

Location

Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

Allentown, Pennsylvania, 18105, United States

Location

Cancer Centers of the Carolinas - Easley

Easley, South Carolina, 29640, United States

Location

Cancer Centers of the Carolinas - Faris Road

Greenville, South Carolina, 29605, United States

Location

Cancer Centers of the Carolinas - Grove Commons

Greenville, South Carolina, 29605, United States

Location

Greenville Hospital Cancer Center

Greenville, South Carolina, 29605, United States

Location

Cancer Centers of the Carolinas - Eastside

Greenville, South Carolina, 29615, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

Cancer Centers of the Carolinas - Greer Medical Oncology

Greer, South Carolina, 29650, United States

Location

Cancer Centers of the Carolinas - Greer Radiation Oncology

Greer, South Carolina, 29650, United States

Location

Cancer Centers of the Carolinas - Seneca

Seneca, South Carolina, 29672, United States

Location

Cancer Centers of the Carolinas - Spartanburg

Spartanburg, South Carolina, 29307, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Sanford Cancer Center at Sanford USD Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

Fredericksburg Oncology, Incorporated

Fredericksburg, Virginia, 22401, United States

Location

Center for Cancer Treatment & Prevention at Sacred Heart Hospital

Eau Claire, Wisconsin, 54701, United States

Location

Marshfield Clinic Cancer Care at Regional Cancer Center

Eau Claire, Wisconsin, 54701, United States

Location

Central Wisconsin Cancer Program at Agnesian HealthCare

Fond du Lac, Wisconsin, 54935, United States

Location

Gundersen Lutheran Center for Cancer and Blood

La Crosse, Wisconsin, 54601, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

Saint Joseph's Hospital

Marshfield, Wisconsin, 54449, United States

Location

Marshfield Clinic - Lakeland Center

Minocqua, Wisconsin, 54548, United States

Location

Ministry Medical Group at Saint Mary's Hospital

Rhinelander, Wisconsin, 54501, United States

Location

Marshfield Clinic - Indianhead Center

Rice Lake, Wisconsin, 54868, United States

Location

Marshfield Clinic at Saint Michael's Hospital

Stevens Point, Wisconsin, 54481, United States

Location

Saint Michael's Hospital Cancer Center

Stevens Point, Wisconsin, 54481, United States

Location

Marshfield Clinic - Weston Center

Weston, Wisconsin, 54476, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Central Nervous System NeoplasmsGlioblastomaGliosarcoma

Interventions

DasatinibTemozolomideRadiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesAstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesDacarbazineTriazenesImidazolesTherapeutics

Results Point of Contact

Title
Nadia Laack M.D.
Organization
Mayo Clinic

Study Officials

  • Nadia N. Laack, MD

    Mayo Clinic

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 26, 2009

Study Start

June 1, 2009

Primary Completion

October 1, 2014

Study Completion

November 15, 2019

Last Updated

February 13, 2020

Results First Posted

May 8, 2017

Record last verified: 2020-02

Locations