Whole-Brain Radiation Therapy With or Without Lapatinib Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer
Conditions
HER2/Neu Positive - Male Breast Carcinoma - Metastatic Malignant Neoplasm in the Brain - Recurrent Breast Carcinoma - Stage IV Breast Cancer
Conditions: official terms
Breast Neoplasms - Breast Neoplasms, Male - Carcinoma - Neoplasms - Neoplasms, Second Primary
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Laboratory Biomarker Analysis Type: Other
Name: Lapatinib Ditosylate Type: Drug
Name: Whole-Brain Radiotherapy Type: Radiation
Overall Status
Recruiting
Summary
This randomized phase II trial studies how well whole-brain radiation therapy (WBRT) with or without lapatinib ditosylate works in treating patients with breast cancer that has too many of a protein called human epidermal growth factor receptor 2 (HER2) on its cells and has spread to the brain. Radiation therapy uses high energy x rays to kill tumor cells. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy together with lapatinib ditosylate is an effective treatment for brain metastasis from breast cancer.
Detailed Description
PRIMARY OBJECTIVES:

I. To determine if there is a signal for an increase in complete response (CR) rate in the brain at 12 weeks post whole-brain radiotherapy (WBRT) as determined by magnetic-resonance imaging (MRI) scan of the brain, with the addition of lapatinib (lapatinib ditosylate) to WBRT compared to WBRT alone.

SECONDARY OBJECTIVES:

I. To evaluate CR rate in the brain at 4 weeks post WBRT as determined by MRI scan of the brain, with the addition of lapatinib to WBRT compared to WBRT alone.

II. To evaluate objective response rate in the brain at 4 and 12 weeks post WBRT as determined by MRI scan of the brain, with the addition of lapatinib to WBRT compared to WBRT alone.

III. To evaluate lesion-specific objective response rate (CR + partial response [PR]) at 4 and 12 weeks post WBRT.

IV. To evaluate overall response with addition of lapatinib to WBRT compared to WBRT alone.

V. To evaluate the central nervous system (CNS) progression-free survival (PFS) rate and overall survival (OS) rate, with the addition of lapatinib to WBRT compared to WBRT alone.

VI. To evaluate treatment-related adverse events when adding lapatinib to WBRT compared to WBRT alone.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo WBRT once daily (QD) 5 days a week for 3 weeks.

ARM II: Patients receive lapatinib ditosylate orally (PO) QD on days 1-42 and undergo WBRT as in Arm I.

After completion of study treatment, patients are followed up at 4 and 12 weeks and then every 12 weeks thereafter.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Pathologically (histologically or cytologically) proven diagnosis of invasive breast cancer

- HER2-overexpressing breast cancer (3+ staining by immunohistochemistry or HER2 gene amplification by fluorescent in situ hybridization [FISH] or silver in situ hybridization [SISH] >= 2.0)

- At least 1 measurable, unirradiated parenchymal brain metastasis within 21 days prior to study entry; the minimum size as measured on T1-weighted gadolinium-enhanced MRI must be as follows according to the number of brain metastases:

- For a single solitary lesion the size must be >= 10 mm

- For 2 or more lesions, the size of at least 2 of the lesions must be >= 5 mm

- Patients may also have the following provided the size requirements above are met:

- Progressive parenchymal brain metastasis following stereotactic radiosurgery for 1-3 brain metastases, with at least 1 new measurable lesion

- Progressive parenchymal brain metastasis following surgical resection of 1-3 brain metastases, with at least 1 measurable brain lesion

- History/physical examination within 21 days prior to study entry

- Karnofsky performance status >= 60% within 21 days prior to study entry

- Able to swallow and retain oral medication (note: for patients unable to swallow tablets, an oral suspension preparation is acceptable)

- Absolute neutrophil count (ANC) >= 1,200 cells/mm^3

- Platelets >= 70,000 cells/mm^3

- Hemoglobin >= 8.0 g/dL (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dL is acceptable)

- Creatinine < 1.5 times institutional upper limit of normal

- Bilirubin < 1.5 times institutional upper limit of normal

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 times institutional upper limit of normal with or without liver metastasis

- Patient must provide study specific informed consent prior to study entry

- Women of childbearing potential must have a negative serum pregnancy test within 21 days prior to study entry

- Sexually active women of childbearing potential and sexually active men must practice adequate contraception during therapy and for 12 months after protocol treatment completion

- Prior lapatinib is allowed as long as the last dose received was > 21 days prior to study entry and provided the patient has not received it at any time after the diagnosis of brain metastasis

Exclusion Criteria:

- Prior WBRT

- Prior radiation therapy (RT) (any site) with concurrent lapatinib defined as 1 or more days on which the patient received both radiation therapy and lapatinib on the same day

- 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

- Prior invasive malignancy (except non-melanomatous skin cancer, curatively resected thyroid papillary carcinoma, and invasive and non-invasive cancers related to the breast cancer) unless disease free for a minimum of 3 years

- Leptomeningeal disease

- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields except patients who have progressed following stereotactic radiosurgery for 1-3 brain metastases, with at least one new lesion

- Severe, active co-morbidity, defined as follows:

- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

- Transmural myocardial infarction within the last 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study entry

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; hepatic or biliary disease that is acute or currently active or that requires antiviral therapy (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment)

- History of left ventricular ejection fraction (LVEF) below institutional normal unless repeated and within institutional normal range within 90 days of study entry

- Grade 2 or greater rash of any cause at time of study entry

- Grade 2 or greater diarrhea of any cause at time of study entry
Locations
The Kirklin Clinic at Acton Road
Birmingham, Alabama, United States
Status: Recruiting
Contact: Jennifer F. De Los Santos - 205-934-0309
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Status: Recruiting
Contact: Jennifer F. De Los Santos - 205-934-0309
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States
Status: Recruiting
Contact: John R. Russell - 877-904-4367 - pfrancisco@usouthal.edu
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Status: Recruiting
Contact: David G. Brachman - 877-602-4111
Sutter Auburn Faith Hospital
Auburn, California, United States
Status: Active, not recruiting
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States
Status: Active, not recruiting
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Status: Active, not recruiting
Mills - Peninsula Hospitals
Burlingame, California, United States
Status: Active, not recruiting
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States
Status: Active, not recruiting
Mercy San Juan Medical Center
Carmichael, California, United States
Status: Terminated
Sutter Davis Hospital
Davis, California, United States
Status: Active, not recruiting
Memorial Medical Center
Modesto, California, United States
Status: Active, not recruiting
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
Status: Active, not recruiting
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States
Status: Active, not recruiting
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States
Status: Active, not recruiting
Stanford Cancer Institute
Palo Alto, California, United States
Status: Active, not recruiting
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States
Status: Active, not recruiting
Sutter Roseville Medical Center
Roseville, California, United States
Status: Active, not recruiting
Mercy General Hospital Radiation Oncology Center
Sacramento, California, United States
Status: Terminated
Radiological Associates of Sacramento
Sacramento, California, United States
Status: Withdrawn
Sutter General Hospital
Sacramento, California, United States
Status: Active, not recruiting
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States
Status: Active, not recruiting
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, United States
Status: Active, not recruiting
Sutter Pacific Medical Foundation
Santa Rosa, California, United States
Status: Active, not recruiting
Palo Atlo Medical Foundation-Sunnyvale
Sunnyvale, California, United States
Status: Active, not recruiting
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, United States
Status: Active, not recruiting
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States
Status: Active, not recruiting
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States
Status: Recruiting
Contact: Samir Narayan - 734-712-4673
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Status: Recruiting
Contact: Neal B. Goldberg - 860-224-5660
Beebe Medical Center
Lewes, Delaware, United States
Status: Active, not recruiting
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Status: Active, not recruiting
Christiana Gynecologic Oncology LLC
Newark, Delaware, United States
Status: Active, not recruiting
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, United States
Status: Active, not recruiting
Helen F Graham Cancer Center
Newark, Delaware, United States
Status: Active, not recruiting
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Status: Active, not recruiting
Regional Hematology and Oncology PA
Newark, Delaware, United States
Status: Active, not recruiting
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Status: Active, not recruiting
Nanticoke Memorial Hospital
Seaford, Delaware, United States
Status: Active, not recruiting
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States
Status: Active, not recruiting
University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
Status: Recruiting
Contact: Judith R. Samuels - 866-574-5124 - Sylvester@emergingmed.com
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Status: Recruiting
Contact: Judith R. Samuels - 866-574-5124 - Sylvester@emergingmed.com
Northside Hospital
Atlanta, Georgia, United States
Status: Recruiting
Contact: Sahar E. Rosenbaum - 404-303-3355
Piedmont Hospital
Atlanta, Georgia, United States
Status: Recruiting
Contact: Adam W. Nowlan - 404-425-7943 - ORS@piedmont.org
Northside Hospital-Forsyth
Cumming, Georgia, United States
Status: Recruiting
Contact: Sahar E. Rosenbaum - 404-303-3355
Piedmont Fayette Hospital
Fayetteville, Georgia, United States
Status: Terminated
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Status: Recruiting
Contact: Frank G. Lake - 770-219-8800 - cancerpatient.navigator@nghs.com
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Status: Recruiting
Contact: Samir Narayan - 734-712-4673
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States
Status: Recruiting
Contact: Thomas E. Lad - 312-864-6000
Saint Joseph Hospital
Chicago, Illinois, United States
Status: Recruiting
Contact: Nicholas S. Galanopoulos - 773-665-3109
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Status: Active, not recruiting
Elkhart Clinic
Elkhart, Indiana, United States
Status: Terminated
Elkhart General Hospital
Elkhart, Indiana, United States
Status: Terminated
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States
Status: Recruiting
Contact: Binh N. Tran - 574-237-1328
Parkview Hospital Randallia
Fort Wayne, Indiana, United States
Status: Recruiting
Contact: Brian K. Chang - 260-373-8888 - parkviewresearch@parkview.com
Radiation Oncology Associates PC
Fort Wayne, Indiana, United States
Status: Recruiting
Contact: Brian K. Chang - 260-373-8888 - parkviewresearch@parkview.com
Community Howard Regional Health
Kokomo, Indiana, United States
Status: Terminated
IU Health La Porte Hospital
La Porte, Indiana, United States
Status: Terminated
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States
Status: Recruiting
Contact: Binh N. Tran - 574-237-1328
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States
Status: Terminated
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States
Status: Recruiting
Contact: Binh N. Tran - 574-237-1328
Memorial Hospital of South Bend
South Bend, Indiana, United States
Status: Terminated
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States
Status: Recruiting
Contact: Binh N. Tran - 574-237-1328
Northern Indiana Cancer Research Consortium CCOP
South Bend, Indiana, United States
Status: Recruiting
Contact: Binh N. Tran - 574-237-1328
South Bend Clinic
South Bend, Indiana, United States
Status: Terminated
Michiana Hematology Oncology PC-Westville
Westville, Indiana, United States
Status: Recruiting
Contact: Binh N. Tran - 574-237-1328
Menorah Medical Center
Overland Park, Kansas, United States
Status: Active, not recruiting
Saint Luke's South Hospital
Overland Park, Kansas, United States
Status: Active, not recruiting
Kansas City CCOP
Prairie Village, Kansas, United States
Status: Recruiting
Contact: Rakesh Gaur - 913-948-5588 - amy.krushelniski@hcahealthcare.com
Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky, United States
Status: Active, not recruiting
Norton Suburban Hospital and Medical Campus
Louisville, Kentucky, United States
Status: Active, not recruiting
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
Status: Recruiting
Contact: Mini J. Elnaggar - 888-562-4763
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Status: Recruiting
Contact: Geoffrey A. Neuner - 443-849-3706
Boston Medical Center
Boston, Massachusetts, United States
Status: Recruiting
Contact: Minh T. Truong - 617-638-8265
Bixby Medical Center
Adrian, Michigan, United States
Status: Terminated
Hickman Cancer Center
Adrian, Michigan, United States
Status: Terminated
Michigan Cancer Research Consortium CCOP
Ann Arbor, Michigan, United States
Status: Terminated
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Samir Narayan - 734-712-4673
Bronson Battle Creek
Battle Creek, Michigan, United States
Status: Recruiting
Contact: Gilbert D. Padula - 616-685-5225 - connie.szczepanek@grcop.org
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, United States
Status: Terminated
Henry Ford Macomb Hospital
Clinton Township, Michigan, United States
Status: Recruiting
Contact: Eleanor M. Walker - 313-916-1784
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Status: Recruiting
Contact: Samir Narayan - 734-712-4673
Henry Ford Hospital
Detroit, Michigan, United States
Status: Recruiting
Contact: Eleanor M. Walker - 313-916-1784
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Status: Recruiting
Contact: Samir Narayan - 734-712-4673
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States
Status: Recruiting
Contact: James L. Leenstra - 920-433-8889
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Status: Recruiting
Contact: Samir Narayan - 734-712-4673
Hurley Medical Center
Flint, Michigan, United States
Status: Recruiting
Contact: Samir Narayan - 734-712-4673
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
Status: Terminated
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States
Status: Recruiting
Contact: Gilbert D. Padula - 616-685-5225 - connie.szczepanek@grcop.org
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States
Status: Recruiting
Contact: Gilbert D. Padula - 616-685-5225 - connie.szczepanek@grcop.org
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States
Status: Recruiting
Contact: James L. Leenstra - 920-433-8889
Allegiance Health
Jackson, Michigan, United States
Status: Recruiting
Contact: Samir Narayan - 734-712-4673
Borgess Medical Center
Kalamazoo, Michigan, United States
Status: Recruiting
Contact: Raymond S. Lord - 269-373-7458
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Status: Recruiting
Contact: Raymond S. Lord - 269-373-7458
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Status: Recruiting
Contact: Raymond S. Lord - 269-373-7458
Sparrow Hospital
Lansing, Michigan, United States
Status: Recruiting
Contact: Samir Narayan - 734-712-4673
Saint Mary Mercy Hospital
Livonia, Michigan, United States
Status: Recruiting
Contact: Samir Narayan - 734-712-4673
Mercy Memorial Hospital
Monroe, Michigan, United States
Status: Terminated
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, United States
Status: Terminated
Mercy Health Mercy Campus
Muskegon, Michigan, United States
Status: Recruiting
Contact: Gilbert D. Padula - 616-685-5225 - connie.szczepanek@grcop.org
Lakeland Community Hospital
Niles, Michigan, United States
Status: Recruiting
Contact: Gilbert D. Padula - 616-685-5225 - connie.szczepanek@grcop.org
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Status: Recruiting
Contact: Samir Narayan - 734-712-4673
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States
Status: Recruiting
Contact: Samir Narayan - 734-712-4673
Saint Mary's of Michigan
Saginaw, Michigan, United States
Status: Recruiting
Contact: Samir Narayan - 734-712-4673
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
Status: Recruiting
Contact: Gilbert D. Padula - 616-685-5225 - connie.szczepanek@grcop.org
Lakeland Hospital
St. Joseph, Michigan, United States
Status: Recruiting
Contact: Gilbert D. Padula - 616-685-5225 - connie.szczepanek@grcop.org
Munson Medical Center
Traverse City, Michigan, United States
Status: Recruiting
Contact: Gilbert D. Padula - 616-685-5225 - connie.szczepanek@grcop.org
Downriver Center for Oncology
Trenton, Michigan, United States
Status: Recruiting
Contact: Eleanor M. Walker - 313-916-1784
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
Status: Recruiting
Contact: Samir Narayan - 734-712-4673
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States
Status: Recruiting
Contact: Eleanor M. Walker - 313-916-1784
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Status: Active, not recruiting
Mercy Hospital
Coon Rapids, Minnesota, United States
Status: Active, not recruiting
Fairview-Southdale Hospital
Edina, Minnesota, United States
Status: Active, not recruiting
Unity Hospital
Fridley, Minnesota, United States
Status: Active, not recruiting
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Status: Active, not recruiting
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Status: Active, not recruiting
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Status: Active, not recruiting
Health Partners Inc
Minneapolis, Minnesota, United States
Status: Active, not recruiting
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Status: Active, not recruiting
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States
Status: Active, not recruiting
Metro-Minnesota NCI Community Oncology Research Program
Saint Louis Park, Minnesota, United States
Status: Terminated
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Status: Active, not recruiting
Regions Hospital
Saint Paul, Minnesota, United States
Status: Active, not recruiting
United Hospital
Saint Paul, Minnesota, United States
Status: Active, not recruiting
Ridgeview Medical Center
Waconia, Minnesota, United States
Status: Active, not recruiting
Rice Memorial Hospital
Willmar, Minnesota, United States
Status: Active, not recruiting
Singing River Hospital
Pascagoula, Mississippi, United States
Status: Recruiting
Contact: James E. Clarkson - 228-809-5292
Cape Radiation Oncology
Cape Girardeau, Missouri, United States
Status: Terminated
Centerpoint Medical Center LLC
Independence, Missouri, United States
Status: Active, not recruiting
Mercy Hospital-Joplin
Joplin, Missouri, United States
Status: Active, not recruiting
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States
Status: Active, not recruiting
North Kansas City Hospital
Kansas City, Missouri, United States
Status: Active, not recruiting
Research Medical Center
Kansas City, Missouri, United States
Status: Active, not recruiting
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Status: Active, not recruiting
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States
Status: Active, not recruiting
Liberty Radiation Oncology Center
Liberty, Missouri, United States
Status: Active, not recruiting
Phelps County Regional Medical Center
Rolla, Missouri, United States
Status: Active, not recruiting
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
Status: Active, not recruiting
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Status: Active, not recruiting
Saint Joseph Oncology Inc
Saint Joseph, Missouri, United States
Status: Terminated
Barnes-Jewish West County Hospital
Saint Louis, Missouri, United States
Status: Recruiting
Contact: Imran Zoberi - 800-600-3606 - info@ccadmin.wustl.edu
Mercy Hospital Saint Louis
Saint Louis, Missouri, United States
Status: Active, not recruiting
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri, United States
Status: Active, not recruiting
Saint Louis-Cape Girardeau CCOP
Saint Louis, Missouri, United States
Status: Withdrawn
Siteman Cancer Center-South County
Saint Louis, Missouri, United States
Status: Recruiting
Contact: Imran Zoberi - 800-600-3606 - info@ccadmin.wustl.edu
Washington University School of Medicine
Saint Louis, Missouri, United States
Status: Recruiting
Contact: Imran Zoberi - 800-600-3606 - info@ccadmin.wustl.edu
Siteman Cancer Center - Saint Peters
Saint Peters, Missouri, United States
Status: Recruiting
Contact: Imran Zoberi - 800-600-3606 - info@ccadmin.wustl.edu
Cancer Research for the Ozarks NCORP
Springfield, Missouri, United States
Status: Terminated
CoxHealth South Hospital
Springfield, Missouri, United States
Status: Recruiting
Contact: Jay W. Carlson - 800-821-7532
Mercy Hospital Springfield
Springfield, Missouri, United States
Status: Active, not recruiting
Renown Regional Medical Center
Reno, Nevada, United States
Status: Recruiting
Contact: Michael C. Hardacre - 775-982-4400
Elliot Hospital
Manchester, New Hampshire, United States
Status: Active, not recruiting
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Status: Active, not recruiting
University of New Mexico
Albuquerque, New Mexico, United States
Status: Recruiting
Contact: Benny J. Liem - 505-272-6972
Memorial Medical Center - Las Cruces
Las Cruces, New Mexico, United States
Status: Recruiting
Contact: Benny J. Liem - 505-272-6972
Montefiore Medical Center - Moses Campus
Bronx, New York, United States
Status: Recruiting
Contact: Mary R. Welch - 718-904-2730 - aecc@aecom.yu.edu
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, United States
Status: Terminated
Mount Sinai Medical Center
New York, New York, United States
Status: Withdrawn
Highland Hospital
Rochester, New York, United States
Status: Recruiting
Contact: Yuhchyau Chen - 585-275-5830
University of Rochester
Rochester, New York, United States
Status: Recruiting
Contact: Yuhchyau Chen - 585-275-5830
Park Ridge Hospital Breast Health Center
Hendersonville, North Carolina, United States
Status: Active, not recruiting
Iredell Memorial Hospital
Statesville, North Carolina, United States
Status: Active, not recruiting
Southeast Cancer Consortium-Upstate NCORP
Winston-Salem, North Carolina, United States
Status: Terminated
Akron General Medical Center
Akron, Ohio, United States
Status: Recruiting
Contact: Mitchel L. Fromm - 330-344-6348
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States
Status: Withdrawn
Radiation Oncology Center
Alliance, Ohio, United States
Status: Withdrawn
Summa Barberton Hospital
Barberton, Ohio, United States
Status: Withdrawn
Cleveland Clinic Cancer Center Beachwood
Beachwood, Ohio, United States
Status: Recruiting
Contact: Samuel T. Chao - 866-223-8100
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, United States
Status: Recruiting
Contact: Simon S. Lo - 800-641-2422
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, United States
Status: Terminated
Mercy Medical Center
Canton, Ohio, United States
Status: Recruiting
Contact: Edward J. Walsh - 888-293-4673
Geaugra Hospital
Chardon, Ohio, United States
Status: Recruiting
Contact: Simon S. Lo - 800-641-2422
Case Western Reserve University
Cleveland, Ohio, United States
Status: Recruiting
Contact: Simon S. Lo - 800-641-2422
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States
Status: Recruiting
Contact: Samuel T. Chao - 866-223-8100
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Status: Recruiting
Contact: Samuel T. Chao - 866-223-8100
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Status: Recruiting
Contact: Allison M. Quick - 800-293-5066 - Jamesline@osumc.edu
Mercy Cancer Center-Elyria
Elyria, Ohio, United States
Status: Recruiting
Contact: Simon S. Lo - 800-641-2422
Cleveland Clinic Cancer Center Independence
Independence, Ohio, United States
Status: Recruiting
Contact: Samuel T. Chao - 866-223-8100
Lima Memorial Hospital
Lima, Ohio, United States
Status: Terminated
Cleveland Clinic Cancer Center Mansfield
Mansfield, Ohio, United States
Status: Recruiting
Contact: Samuel T. Chao - 866-223-8100
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States
Status: Terminated
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, United States
Status: Terminated
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States
Status: Recruiting
Contact: Samuel T. Chao - 866-223-8100
Summa Health Center at Lake Medina
Medina, Ohio, United States
Status: Withdrawn
Lake University Ireland Cancer Center
Mentor, Ohio, United States
Status: Recruiting
Contact: Simon S. Lo - 800-641-2422
Southwest General Health Center Ireland Cancer Center
Middleburg Heights, Ohio, United States
Status: Recruiting
Contact: Simon S. Lo - 800-641-2422
Saint Charles Hospital
Oregon, Ohio, United States
Status: Terminated
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States
Status: Terminated
University Hospitals Parma Medical Center
Parma, Ohio, United States
Status: Recruiting
Contact: Simon S. Lo - 800-641-2422
Robinson Radiation Oncology
Ravenna, Ohio, United States
Status: Recruiting
Contact: Mitchel L. Fromm - 330-344-6348
Cancer Care Center, Incorporated
Salem, Ohio, United States
Status: Terminated
North Coast Cancer Care
Sandusky, Ohio, United States
Status: Recruiting
Contact: Samuel T. Chao - 866-223-8100
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio, United States
Status: Recruiting
Contact: Samuel T. Chao - 866-223-8100
Flower Hospital
Sylvania, Ohio, United States
Status: Active, not recruiting
Mercy Hospital of Tiffin
Tiffin, Ohio, United States
Status: Terminated
Mercy Saint Anne Hospital
Toledo, Ohio, United States
Status: Terminated
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States
Status: Terminated
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States
Status: Terminated
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States
Status: Terminated
University of Toledo
Toledo, Ohio, United States
Status: Active, not recruiting
Fulton County Health Center
Wauseon, Ohio, United States
Status: Terminated
UHHS-Westlake Medical Center
Westlake, Ohio, United States
Status: Recruiting
Contact: Simon S. Lo - 800-641-2422
Cancer Treatment Center
Wooster, Ohio, United States
Status: Terminated
Cleveland Clinic Wooster Specialty Center
Wooster, Ohio, United States
Status: Recruiting
Contact: Samuel T. Chao - 866-223-8100
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, United States
Status: Terminated
Oklahoma Oncology Inc
Tulsa, Oklahoma, United States
Status: Terminated
Warren Cancer Research Foundation
Tulsa, Oklahoma, United States
Status: Terminated
Abington Memorial Hospital
Abington, Pennsylvania, United States
Status: Recruiting
Contact: Wayne H. Pinover - 215-481-2402
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Status: Active, not recruiting
Reading Hospital
West Reading, Pennsylvania, United States
Status: Recruiting
Contact: Michael L. Haas - 610-988-9323
AnMed Health Cancer Center
Anderson, South Carolina, United States
Status: Active, not recruiting
Medical University of South Carolina
Charleston, South Carolina, United States
Status: Active, not recruiting
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States
Status: Active, not recruiting
Spartanburg Medical Center
Spartanburg, South Carolina, United States
Status: Recruiting
Contact: Patricia C. Griffin - 800-486-5941
Covenant Medical Center-Lakeside
Lubbock, Texas, United States
Status: Recruiting
Contact: Paul J. Anderson - 806-725-8000 - jaccresearch@covhs.org
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Status: Active, not recruiting
Central Vermont Medical Center/National Life Cancer Treatment
Berlin, Vermont, United States
Status: Recruiting
Contact: Deborah Z. Rubin - 802-656-4101
University of Vermont College of Medicine
Burlington, Vermont, United States
Status: Recruiting
Contact: Deborah Z. Rubin - 802-656-4101
University of Vermont Medical Center
Burlington, Vermont, United States
Status: Recruiting
Contact: Deborah Z. Rubin - 802-656-4101
Fredericksburg Oncology Inc
Fredericksburg, Virginia, United States
Status: Terminated
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Status: Recruiting
Contact: Timothy J. Harris - 804-628-1939
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, United States
Status: Recruiting
Contact: Jondavid Pollock - 304-243-6442
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States
Status: Recruiting
Contact: James L. Leenstra - 920-433-8889
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States
Status: Recruiting
Contact: James L. Leenstra - 920-433-8889
Saint Mary's Hospital
Green Bay, Wisconsin, United States
Status: Recruiting
Contact: James L. Leenstra - 920-433-8889
Saint Vincent Hospital
Green Bay, Wisconsin, United States
Status: Recruiting
Contact: James L. Leenstra - 920-433-8889
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, United States
Status: Recruiting
Contact: Bethany M. Anderson - 877-405-6866
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Status: Recruiting
Contact: Bethany M. Anderson - 877-405-6866
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States
Status: Recruiting
Contact: James L. Leenstra - 920-433-8889
Bay Area Medical Center
Marinette, Wisconsin, United States
Status: Recruiting
Contact: James L. Leenstra - 920-433-8889
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, United States
Status: Active, not recruiting
Columbia Saint Mary's Water Tower Medical Commons
Milwaukee, Wisconsin, United States
Status: Active, not recruiting
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Status: Active, not recruiting
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States
Status: Active, not recruiting
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States
Status: Recruiting
Contact: James L. Leenstra - 920-433-8889
Door County Cancer Center
Sturgeon Bay, Wisconsin, United States
Status: Recruiting
Contact: James L. Leenstra - 920-433-8889
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Status: Recruiting
Contact: James L. Leenstra - 920-433-8889
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
Status: Recruiting
Contact: Jeffrey N. Greenspoon - 905-387-9495
Jewish General Hospital
Montreal, Quebec, Canada
Status: Recruiting
Contact: Thierry M. Muanza - 514-398-1444 - penny.chipman@mcgill.ca
Keimyung University-Dongsan Medical Center
Jung-Ku, Daegu, Korea, Republic of
Status: Active, not recruiting
National Cancer Center-Korea
Goyang-si, Gyeonggi-do, Korea, Republic of
Status: Active, not recruiting
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, Korea, Republic of
Status: Active, not recruiting
Samsung Medical Center
Seoul, Korea, Korea, Republic of
Status: Active, not recruiting
Seoul National University Bundang Hospital
Seongnam City, Kyeonggi-do, Korea, Republic of
Status: Active, not recruiting
Gangnam Severance Hospital
Seoul, Korea, Republic of
Status: Active, not recruiting
Yonsei University Health System-Severance Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Chang Ok Suh - 888-823-5923 - ctsucontact@westat.com
Start Date
July 2012
Sponsors
National Cancer Institute (NCI)
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page