Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase I/II Randomized Study of Dasatinib Versus Placebo and Chemoradiotherapy With Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

Basic Trial Information

Trial Description

Purpose:

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.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No previous radiation therapy or chemotherapy for any CNS tumor
• Less than 6 weeks since stereotactic biopsy or craniotomy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be assigned to group one or randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive dasatinib by mouth once a day and temozolomide by mouth once a day for 6 weeks. They will also undergo radiation therapy 5 days a week for 6 weeks. Beginning 4-6 weeks after course one, patients will receive dasatinib by mouth once a day for 4 weeks and temozolomide by mouth once a day for 5 days. Treatment may repeat every 4 weeks for up to 6 courses.

Patients in group two will receive a placebo by mouth once a day and temozolomide by mouth once a day for 6 weeks. They will also undergo radiation therapy 5 days a week for 6 weeks. Beginning 4-6 weeks after course one, patients will receive a placebo once a day for 4 weeks and temozolomide by mouth once a day for 5 days. Treatment may repeat every 4 weeks for up to 6 courses.

Blood samples will be collected and stored for future laboratory studies.

Patients will fill out quality-of-life questionnaires periodically. After finishing treatment, patients will be evaluated every 6 months for 5 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Nadia Laack, MD, Protocol chair		Ph: 507-284-3559

U.S.A.
Florida
	Jacksonville
	Mayo Clinic - Jacksonville
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Illinois
	Bloomington
	St. Joseph Medical Center
		John Kugler, MD	Ph:  309-243-3605
	Bloomington%
	Illinois CancerCare - Bloomington
		John Kugler, MD	Ph:  309-243-3605
	Canton
	Graham Hospital
		John Kugler, MD	Ph:  309-243-3605
	Illinois CancerCare - Canton
		John Kugler, MD	Ph:  309-243-3605
	Carthage
	Illinois CancerCare - Carthage
		John Kugler, MD	Ph:  309-243-3605
	Eureka
	Eureka Community Hospital
		John Kugler, MD	Ph:  309-243-3605
	Illinois CancerCare - Eureka
		John Kugler, MD	Ph:  309-243-3605
	Galesburg
	Galesburg Clinic, PC
		John Kugler, MD	Ph:  309-243-3605
	Illinois CancerCare - Galesburg
		John Kugler, MD	Ph:  309-243-3605
	Havana
	Illinois CancerCare - Havana
		John Kugler, MD	Ph:  309-243-3605
	Mason District Hospital
		John Kugler, MD	Ph:  309-243-3605
	Kewanee
	Illinois CancerCare - Kewanee Clinic
		John Kugler, MD	Ph:  309-243-3605
	Macomb
	Illinois CancerCare - Macomb
		John Kugler, MD	Ph:  309-243-3605
	McDonough District Hospital
		John Kugler, MD	Ph:  309-243-3605
	Monmouth
	Illinois CancerCare - Monmouth
		John Kugler, MD	Ph:  309-243-3605
	OSF Holy Family Medical Center
		John Kugler, MD	Ph:  309-243-3605
	Normal
	BroMenn Regional Medical Center
		John Kugler, MD	Ph:  309-243-3605
	Community Cancer Center
		John Kugler, MD	Ph:  309-243-3605
	Illinois CancerCare - Community Cancer Center
		John Kugler, MD	Ph:  309-243-3605
	Ottawa
	Community Hospital of Ottawa
		John Kugler, MD	Ph:  309-243-3605
	Oncology Hematology Associates of Central Illinois, PC - Ottawa
		John Kugler, MD	Ph:  309-243-3605
	Pekin
	Cancer Treatment Center at Pekin Hospital
		John Kugler, MD	Ph:  309-243-3605
	Peoria
	CCOP - Illinois Oncology Research Association
		John Kugler, MD	Ph:  309-243-3605
	Methodist Medical Center of Illinois
		Clinical Trials Office - Methodist Medical Center of Illinois	Ph:  309-243-3000
	Oncology Hematology Associates of Central Illinois, PC - Peoria
		John Kugler, MD	Ph:  309-243-3605
	OSF St. Francis Medical Center
		John Kugler, MD	Ph:  309-243-3605
	Proctor Hospital
		John Kugler, MD	Ph:  309-243-3605
	Peru
	Illinois CancerCare - Peru
		John Kugler, MD	Ph:  309-243-3605
	Illinois Valley Community Hospital
		John Kugler, MD	Ph:  309-243-3605
	Princeton
	Illinois CancerCare - Princeton
		John Kugler, MD	Ph:  309-243-3605
	Perry Memorial Hospital
		John Kugler, MD	Ph:  309-243-3605
Indiana
	Beech Grove
	St. Francis Hospital and Health Centers - Beech Grove Campus
		Howard Gross, MD	Ph:  937-832-1093
	Richmond
	Reid Hospital & Health Care Services
		Howard Gross, MD	Ph:  937-832-1093
Iowa
	Cedar Rapids
	Cedar Rapids Oncology Associates
		Clinical Trials Office - Cedar Rapids Oncology Associates	Ph:  319-363-2690
	Mercy Regional Cancer Center at Mercy Medical Center
		Deborah Wilbur	Ph:  319-398-6011
	Clive
	Medical Oncology and Hematology Associates - West Des Moines
		Robert Behrens	Ph:  515-875-9713
	Mercy Cancer Center - West Lakes
		Robert Behrens	Ph:  515-643-8206 888-221-4849
	Des Moines
	CCOP - Iowa Oncology Research Association
		Robert Behrens	Ph:  515-244-7586 888-244-6061
	John Stoddard Cancer Center at Iowa Lutheran Hospital
		Clinical Trials Office - John Stoddard Cancer Center at Iowa Lutheran Hospital	Ph:  515-241-8704
	John Stoddard Cancer Center at Iowa Methodist Medical Center
		Clinical Trials Office - John Stoddard Cancer Center at Iowa Methodist Medical Center	Ph:  515-241-6727
	Medical Oncology and Hematology Associates at John Stoddard Cancer Center
		Robert Behrens	Ph:  515-282-2921
	Medical Oncology and Hematology Associates at Mercy Cancer Center
		Robert Behrens	Ph:  515-643-8740
	Mercy Cancer Center at Mercy Medical Center - Des Moines
		Robert Behrens	Ph:  515-643-8206 888-221-4849
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Wender, MD, PhD	Ph:  712-252-0088
	Siouxland Hematology-Oncology Associates, LLP
		Donald Wender, MD, PhD	Ph:  712-252-0088
	St. Luke's Regional Medical Center
		Donald Wender, MD, PhD	Ph:  712-252-0088
	West Des Moines
	Mercy Cancer Center at Mercy Medical Center - Des Moines
		Robert Behrens	Ph:  515-643-8206 888-221-4849
	Methodist West Hospital
		Robert Behrens	Ph:  515-343-1000
Michigan
	Adrian
	Hickman Cancer Center at Bixby Medical Center
		Clinical Trials Office - Hickman Cancer Center at Bixby Medical Center	Ph:  517-265-0116
	Monroe
	Community Cancer Center of Monroe
		Rex Mowat	Ph:  734-242-7902
	Mercy Memorial Hospital - Monroe
		Rex Mowat	Ph:  734-240-8400
Minnesota
	Bemidji
	MeritCare Bemidji
		Preston Steen, MD	Ph:  701-234-2397
	Burnsville
	Fairview Ridges Hospital
		Daniel Anderson	Ph:  952-892-2000
	Coon Rapids
	Mercy and Unity Cancer Center at Mercy Hospital
		Daniel Anderson	Ph:  763-236-6000
	Duluth
	CCOP - Duluth
		Bret Friday	Ph:  218-786-8364
	Duluth Clinic Cancer Center - Duluth
		Clinical Trials Office - Duluth Clinic Cancer Center - Duluth	Ph:  218-786-3308
	Miller - Dwan Medical Center
		Bret Friday	Ph:  218-727-8762
	Edina
	Fairview Southdale Hospital
		Clinical Trials Office - Fairview Southdale Hospital	Ph:  612-625-3650
	Fridley
	Mercy and Unity Cancer Center at Unity Hospital
		Daniel Anderson	Ph:  763-236-5000
	Hutchinson
	Hutchinson Area Health Care
		Daniel Anderson	Ph:  320-234-5000 800-454-3903
	Maplewood
	HealthEast Cancer Care at St. John's Hospital
		Daniel Anderson	Ph:  651-232-7970
	Minnesota Oncology - Maplewood
		Daniel Anderson	Ph:  651-779-7978
	Minneapolis
	Hennepin County Medical Center - Minneapolis
		Clinical Trials Office - Hennepin County Medical Center - Minneapolis	Ph:  612-873-5911
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Clinical Trials Office - Virginia Piper Cancer Institute	Ph:  612-863-5654
	Robbinsdale
	Humphrey Cancer Center at North Memorial Outpatient Center
		Clinical Trials Office - Humphrey Cancer Center at North Memorial Outpatient Center	Ph:  763-520-1893
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Saint Louis Park
	CCOP - Metro-Minnesota
		Daniel Anderson	Ph:  952-993-1517
	Park Nicollet Cancer Center
		Daniel Anderson	Ph:  952-993-3248
	Saint Paul
	United Hospital
		Daniel Anderson	Ph:  651-241-8000
	Shakopee
	St. Francis Cancer Center at St. Francis Medical Center
		Daniel Anderson	Ph:  952-403-2031
	St. Paul
	Regions Hospital Cancer Care Center
		Clinical Trials Office - Regions Hospital Cancer Care Center	Ph:  651-254-1517
	Stillwater
	Lakeview Hospital
		Daniel Anderson	Ph:  651-439-5330 800-423-7212
	Waconia
	Ridgeview Medical Center
		Daniel Anderson	Ph:  952-442-2191 800-967-4620
	Willmar
	Willmar Cancer Center at Rice Memorial Hospital
		Daniel Anderson	Ph:  320-231-4650 800-247-1478
	Woodbury
	Minnesota Oncology - Woodbury
		Daniel Anderson	Ph:  651-735-7414
New Mexico
	Albuquerque
	University of New Mexico Cancer Center
		Clinical Trials Office - University of New Mexico Cancer Center	Ph:  505-272-6972
North Dakota
	Fargo
	CCOP - MeritCare Hospital
		Preston Steen, MD	Ph:  701-234-2397
	MeritCare Broadway
		Preston Steen, MD	Ph:  701-234-2397
	Grand Forks
	Altru Cancer Center at Altru Hospital
		Clinical Trails Office - Altru Cancer Center at Altru Hospital	Ph:  701-780-6520
Ohio
	Bowling Green
	Wood County Oncology Center
		Rex Mowat	Ph:  419-352-9498
	Cincinnati
	Charles M. Barrett Cancer Center at University Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Dayton
	CCOP - Dayton
		Howard Gross, MD	Ph:  937-832-1093
	David L. Rike Cancer Center at Miami Valley Hospital
		Clinical Trials Office - David L. Rike Cancer Center at Miami Valley Hospital	Ph:  937-208-2079
	Good Samaritan Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Grandview Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Samaritan North Cancer Care Center
		Howard Gross, MD	Ph:  937-832-1093
	Elyria
	Community Cancer Center
		Rex Mowat	Ph:  440-324-0400
	Hematology Oncology Center
		Rex Mowat	Ph:  440-324-0401
	Findlay
	Blanchard Valley Medical Associates
		Howard Gross, MD	Ph:  937-832-1093
	Franklin
	Middletown Regional Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Greenville
	Wayne Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Kettering
	Charles F. Kettering Memorial Hospital
		Clinical Trials Office - Charles F. Kettering Memorial Hospital	Ph:  937-298-3399 ext. 57556
	Lima
	Lima Memorial Hospital
		Rex Mowat	Ph:  419-228-3335
	Maumee
	Northwest Ohio Oncology Center
		Rex Mowat	Ph:  419-891-5600
		Rex Mowat	Ph:  419-891-5600
	Norwalk
	Fisher-Titus Medical Center
		Rex Mowat	Ph:  419-668-8101 800-589-3862
	Oregon
	St. Charles Mercy Hospital
		Rex Mowat	Ph:  419-696-7200
	Toledo Clinic - Oregon
		Rex Mowat	Ph:  419-691-4235
	Sylvania
	Flower Hospital Cancer Center
		Clinical Trials Office - Flower Hospital Cancer Center	Ph:  419-824-1842
	Tiffin
	Mercy Hospital of Tiffin
		Rex Mowat	Ph:  419-447-3130
	Toledo
	CCOP - Toledo Community Hospital
		Rex Mowat	Ph:  419-843-6147
	Medical University of Ohio Cancer Center
		Clinical Trials Office - Medical University of Ohio Cancer Center	Ph:  419-383-6583
	St. Anne Mercy Hospital
		Rex Mowat	Ph:  419-407-2663
	St. Vincent Mercy Medical Center
		Rex Mowat	Ph:  419-251-4515
	Toledo Clinic, Incorporated - Main Clinic
		Rex Mowat	Ph:  419-479-5605
	Toledo Hospital
		Clinical Trials Office - Toledo Hospital	Ph:  419-824-1842
	Troy
	UVMC Cancer Care Center at Upper Valley Medical Center
		Clinical Trials Office - UVMC Cancer Care Center at Upper Valley Medical Center	Ph:  937-440-4842
	Wauseon
	Fulton County Health Center
		Clinical Trials Office - Fulton County Health Center	Ph:  419-330-2708
	West Chester
	Precision Radiotherapy at University Pointe
		Howard Gross, MD	Ph:  937-832-1093
	Xenia
	Ruth G. McMillan Cancer Center at Greene Memorial Hospital
		Howard Gross, MD	Ph:  937-832-1093
Pennsylvania
	Allentown
	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
		Suresh Nair, MD	Ph:  610-402-0512
South Dakota
	Rapid City
	Rapid City Regional Hospital
		Richard Tenglin	Ph:  605-719-2360
	Sioux Falls
	Avera Cancer Institute
		Addison Tolentino	Ph:  605-322-3000
		Addison Tolentino	Ph:  605-322-3000
	Sanford Cancer Center at Sanford USD Medical Center
		Clinical Trials Office - Sanford Cancer Center	Ph:  605-328-1367
Virginia
	Fredericksburg
	Fredericksburg Oncology, Incorporated
		Rex Mowat	Ph:  540-368-0500
Wisconsin
	Fond du Lac
	Central Wisconsin Cancer Program at Agnesian HealthCare
		Clinical Trials Office - Central Wisconsin Cancer Program at Agnesian HealthCare	Ph:  800-494-2927

Registry Information
Official Title		Phase I/Randomized Phase II Trial of Either Dasatinib or Placebo Combined with Standard Chemo-Radiotherapy for Newly Diagnosed Glioblastoma Multiforme (GBM)
Trial Start Date		2009-06-05
Trial Completion Date		2011-07-01 (estimated)
Registered in ClinicalTrials.gov		NCT00869401
Date Submitted to PDQ		2009-03-11
Information Last Verified		2012-05-09
NCI Grant/Contract Number		CA25224

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