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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00869401
Other study ID # NCCTG-N0877
Secondary ID NCI-2009-01179CD
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date June 2009
Est. completion date November 15, 2019

Study information

Verified date February 2020
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 217
Est. completion date November 15, 2019
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

6. Required INR Value: The following INR value obtained = 28 days prior to registration

- INR = 1.5

7. Urine or Serum Pregnancy Test - Negative urine or serum pregnancy test done = 7 days prior to registration, for women of childbearing potential only.

8. Written Informed Consent - Patient must provide written informed consent.

9. Return to Enrolling Institution - Patient must be willing to return to Alliance enrolling institution for follow-up.

10. Tissue Samples - Patient must be willing to provide tissue samples for research purposes.

11. Patient must be willing to provide tissue samples for research purposes.

12. Required Antibiotic Prophylaxis - Patient must be willing to comply with antibiotic prophylaxis with trimethoprim/sulfamethoxazole, pentamidine or dapsone.

13. Grapefruit and Grapefruit Juice - Patient must be willing to abstain from eating grapefruit or drinking grapefruit juice for the duration of the study treatment.

14. Ability to Swallow - Patient must have the ability to take oral medication (dasatinib must be swallowed whole).

15. 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.

16. 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.

2. 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.

3. 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.

4. 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

5. Pleural or Pericardial Effusions - Pleural or pericardial effusion of any grade.

6. 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.

7. 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.

8. Other Investigational Agents - Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.

9. 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.

10. 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.

11. 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.

12. Congestive Heart Failure - New York Heart Association classification = Class II Congestive Heart Failure.

13. 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.

14. Allergy to Antibiotic Prophylaxis Medications - Severe allergy to sulfa medications and dapsone and pentamidine.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
dasatinib
Given orally
temozolomide
Given orally
Other:
placebo
Given orally
Radiation:
radiation therapy
Radiation therapy is performed as 30 fractions of 200 cGy for a total of 6000 cGy.

Locations

Country Name City State
United States Hickman Cancer Center at Bixby Medical Center Adrian Michigan
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown Pennsylvania
United States Mission Hospitals - Memorial Campus Asheville North Carolina
United States MeritCare Bemidji Bemidji Minnesota
United States Billings Clinic - Downtown Billings Montana
United States CCOP - Montana Cancer Consortium Billings Montana
United States Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana
United States St. Vincent Healthcare Cancer Care Services Billings Montana
United States Medcenter One Hospital Cancer Care Center Bismarck North Dakota
United States Mid Dakota Clinic, PC Bismarck North Dakota
United States St. Alexius Medical Center Cancer Center Bismarck North Dakota
United States Illinois CancerCare - Bloomington Bloomington Illinois
United States St. Joseph Medical Center Bloomington Illinois
United States Wood County Oncology Center Bowling Green Ohio
United States Bozeman Deaconess Cancer Center Bozeman Montana
United States Fairview Ridges Hospital Burnsville Minnesota
United States St. James Healthcare Cancer Care Butte Montana
United States Illinois CancerCare - Canton Canton Illinois
United States Illinois CancerCare - Carthage Carthage Illinois
United States Cedar Rapids Oncology Associates Cedar Rapids Iowa
United States Mercy Regional Cancer Center at Mercy Medical Center Cedar Rapids Iowa
United States Cancer Center of Kansas, PA - Chanute Chanute Kansas
United States Resurrection Medical Center Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Charles M. Barrett Cancer Center at University Hospital Cincinnati Ohio
United States Medical Oncology and Hematology Associates - West Des Moines Clive Iowa
United States Mercy Cancer Center - West Lakes Clive Iowa
United States CCOP - Columbus Columbus Ohio
United States Doctors Hospital at Ohio Health Columbus Ohio
United States Grant Medical Center Cancer Care Columbus Ohio
United States John B. Amos Cancer Center Columbus Georgia
United States Mount Carmel Health - West Hospital Columbus Ohio
United States Riverside Methodist Hospital Cancer Care Columbus Ohio
United States New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Concord New Hampshire
United States Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota
United States CCOP - Dayton Dayton Ohio
United States David L. Rike Cancer Center at Miami Valley Hospital Dayton Ohio
United States Good Samaritan Hospital Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Samaritan North Cancer Care Center Dayton Ohio
United States Grady Memorial Hospital Delaware Ohio
United States CCOP - Iowa Oncology Research Association Des Moines Iowa
United States John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines Iowa
United States John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa
United States Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa
United States Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa
United States Cancer Center of Kansas, PA - Dodge City Dodge City Kansas
United States CCOP - Duluth Duluth Minnesota
United States Essentia Health - Duluth Clinic Duluth Minnesota
United States Miller - Dwan Medical Center Duluth Minnesota
United States Cancer Centers of the Carolinas - Easley Easley South Carolina
United States CCOP - Hematology-Oncology Associates of Central New York East Syracuse New York
United States Center for Cancer Treatment & Prevention at Sacred Heart Hospital Eau Claire Wisconsin
United States Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire Wisconsin
United States Fairview Southdale Hospital Edina Minnesota
United States Cancer Center of Kansas, PA - El Dorado El Dorado Kansas
United States Elkhart Clinic, LLC Elkhart Indiana
United States Elkhart General Hospital Elkhart Indiana
United States Michiana Hematology-Oncology, PC - Elkhart Elkhart Indiana
United States Community Cancer Center Elyria Ohio
United States Hematology Oncology Center Elyria Ohio
United States Eureka Community Hospital Eureka Illinois
United States Illinois CancerCare - Eureka Eureka Illinois
United States MeritCare Broadway Fargo North Dakota
United States Blanchard Valley Medical Associates Findlay Ohio
United States Central Wisconsin Cancer Program at Agnesian HealthCare Fond Du Lac Wisconsin
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Middletown Regional Hospital Franklin Ohio
United States Fredericksburg Oncology, Incorporated Fredericksburg Virginia
United States Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota
United States Galesburg Clinic, PC Galesburg Illinois
United States Wayne Memorial Hospital, Incorporated Goldsboro North Carolina
United States Altru Cancer Center at Altru Hospital Grand Forks North Dakota
United States Benefis Sletten Cancer Institute Great Falls Montana
United States Cancer Centers of the Carolinas - Eastside Greenville South Carolina
United States Cancer Centers of the Carolinas - Faris Road Greenville South Carolina
United States Cancer Centers of the Carolinas - Grove Commons Greenville South Carolina
United States CCOP - Greenville Greenville South Carolina
United States Greenville Hospital Cancer Center Greenville South Carolina
United States Wayne Hospital Greenville Ohio
United States Cancer Centers of the Carolinas - Greer Medical Oncology Greer South Carolina
United States Cancer Centers of the Carolinas - Greer Radiation Oncology Greer South Carolina
United States Helen and Harry Gray Cancer Center at Hartford Hospital Hartford Connecticut
United States Illinois CancerCare - Havana Havana Illinois
United States St. Peter's Hospital Helena Montana
United States New Hampshire Oncology - Hematology, PA - Hooksett Hooksett New Hampshire
United States Hutchinson Area Health Care Hutchinson Minnesota
United States Cancer Center of Kansas-Independence Independence Kansas
United States St. Francis Hospital Cancer Care Services Indianapolis Indiana
United States Mayo Clinic - Jacksonville Jacksonville Florida
United States Kalispell Regional Medical Center Kalispell Montana
United States Charles F. Kettering Memorial Hospital Kettering Ohio
United States Illinois CancerCare - Kewanee Clinic Kewanee Illinois
United States Cancer Center of Kansas, PA - Kingman Kingman Kansas
United States Howard Community Hospital Kokomo Indiana
United States Gundersen Lutheran Center for Cancer and Blood La Crosse Wisconsin
United States Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte Indiana
United States Lakes Region General Hospital Laconia New Hampshire
United States Fairfield Medical Center Lancaster Ohio
United States Lawrence Memorial Hospital Lawrence Kansas
United States Cancer Center of Kansas, PA - Liberal Liberal Kansas
United States Lima Memorial Hospital Lima Ohio
United States Illinois CancerCare - Macomb Macomb Illinois
United States HealthEast Cancer Care at St. John's Hospital Maplewood Minnesota
United States Minnesota Oncology - Maplewood Maplewood Minnesota
United States Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio
United States Marshfield Clinic - Marshfield Center Marshfield Wisconsin
United States Saint Joseph's Hospital Marshfield Wisconsin
United States Northwest Ohio Oncology Center Maumee Ohio
United States Hennepin County Medical Center - Minneapolis Minneapolis Minnesota
United States Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis Minnesota
United States Marshfield Clinic - Lakeland Center Minocqua Wisconsin
United States Michiana Hematology-Oncology, PC - South Bend Mishawaka Indiana
United States Saint Joseph Regional Medical Center Mishawaka Indiana
United States Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana
United States Montana Cancer Specialists at Montana Cancer Center Missoula Montana
United States Illinois CancerCare - Monmouth Monmouth Illinois
United States OSF Holy Family Medical Center Monmouth Illinois
United States Community Cancer Center of Monroe Monroe Michigan
United States Mercy Memorial Hospital - Monroe Monroe Michigan
United States Knox Community Hospital Mount Vernon Ohio
United States Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark Ohio
United States Cancer Center of Kansas, PA - Newton Newton Kansas
United States BroMenn Regional Medical Center Normal Illinois
United States Community Cancer Center Normal Illinois
United States Illinois CancerCare - Community Cancer Center Normal Illinois
United States St. Charles Mercy Hospital Oregon Ohio
United States Toledo Clinic - Oregon Oregon Ohio
United States Community Hospital of Ottawa Ottawa Illinois
United States Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa Illinois
United States Cancer Center of Kansas, PA - Parsons Parsons Kansas
United States Cancer Treatment Center at Pekin Hospital Pekin Illinois
United States Illinois CancerCare - Pekin Pekin Illinois
United States CCOP - Illinois Oncology Research Association Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria Illinois
United States OSF St. Francis Medical Center Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois CancerCare - Peru Peru Illinois
United States Illinois Valley Community Hospital Peru Illinois
United States Michiana Hematology Oncology PC - Plymouth Plymouth Indiana
United States Southern Ohio Medical Center Cancer Center Portsmouth Ohio
United States Cancer Center of Kansas, PA - Pratt Pratt Kansas
United States Illinois CancerCare - Princeton Princeton Illinois
United States Rapid City Regional Hospital Rapid City South Dakota
United States Ministry Medical Group at Saint Mary's Hospital Rhinelander Wisconsin
United States Marshfield Clinic - Indianhead Center Rice Lake Wisconsin
United States Reid Hospital & Health Care Services Richmond Indiana
United States Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale Minnesota
United States Mayo Clinic Cancer Center Rochester Minnesota
United States CentraCare Clinic - River Campus Saint Cloud Minnesota
United States Coborn Cancer Center Saint Cloud Minnesota
United States Lakeland Regional Cancer Care Center - St. Joseph Saint Joseph Michigan
United States Lakeside Cancer Specialists, PLLC Saint Joseph Michigan
United States Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Saint Louis Missouri
United States CCOP - Metro-Minnesota Saint Louis Park Minnesota
United States Park Nicollet Cancer Center Saint Louis Park Minnesota
United States Regions Hospital Cancer Care Center Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Cancer Center of Kansas, PA - Salina Salina Kansas
United States Cancer Centers of the Carolinas - Seneca Seneca South Carolina
United States St. Francis Cancer Center at St. Francis Medical Center Shakopee Minnesota
United States Mercy Medical Center - Sioux City Sioux City Iowa
United States Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa
United States St. Luke's Regional Medical Center Sioux City Iowa
United States Avera Cancer Institute Sioux Falls South Dakota
United States Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota
United States CCOP - Northern Indiana CR Consortium South Bend Indiana
United States Memorial Hospital of South Bend South Bend Indiana
United States Cancer Centers of the Carolinas - Spartanburg Spartanburg South Carolina
United States Illinois CancerCare - Spring Valley Spring Valley Illinois
United States Valley Cancer Center Spring Valley Illinois
United States Community Hospital of Springfield and Clark County Springfield Ohio
United States Marshfield Clinic at Saint Michael's Hospital Stevens Point Wisconsin
United States Saint Michael's Hospital Cancer Center Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Flower Hospital Cancer Center Sylvania Ohio
United States Mercy Hospital of Tiffin Tiffin Ohio
United States Medical University of Ohio Cancer Center Toledo Ohio
United States St. Anne Mercy Hospital Toledo Ohio
United States St. Vincent Mercy Medical Center Toledo Ohio
United States Toledo Clinic, Incorporated - Main Clinic Toledo Ohio
United States Toledo Hospital Toledo Ohio
United States UVMC Cancer Care Center at Upper Valley Medical Center Troy Ohio
United States Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa Oklahoma
United States CCOP - Carle Cancer Center Urbana Illinois
United States Ridgeview Medical Center Waconia Minnesota
United States Fulton County Health Center Wauseon Ohio
United States Cancer Center of Kansas, PA - Wellington Wellington Kansas
United States Precision Radiotherapy at University Pointe West Chester Ohio
United States Methodist West Hospital West Des Moines Iowa
United States Mount Carmel St. Ann's Cancer Center Westerville Ohio
United States Marshfield Clinic - Weston Center Weston Wisconsin
United States Michiana Hematology Oncology PC - La Porte Westville Indiana
United States Associates in Womens Health, PA - North Review Wichita Kansas
United States Cancer Center of Kansas, PA - Medical Arts Tower Wichita Kansas
United States Cancer Center of Kansas, PA - Wichita Wichita Kansas
United States CCOP - Wichita Wichita Kansas
United States Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas
United States Wesley Medical Center Wichita Kansas
United States Willmar Cancer Center at Rice Memorial Hospital Willmar Minnesota
United States Cancer Center of Kansas, PA - Winfield Winfield Kansas
United States Minnesota Oncology - Woodbury Woodbury Minnesota
United States Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia Ohio
United States Genesis - Good Samaritan Hospital Zanesville Ohio

Sponsors (3)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology Bristol-Myers Squibb, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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 Up to 5 years post treatment
Secondary 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. Up to 5 years post treatment
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