Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission

NCT ID: NCT00093470

Last Updated: 2024-03-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-18

Brief Summary

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This randomized phase III trial studies tipifarnib in treating patients with acute myeloid leukemia (AML) in remission. Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It is not yet known whether tipifarnib is more effective than observation alone in preventing the recurrence of AML.

Detailed Description

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PRIMARY OBJECTIVES:

I. To compare R115777 (tipifarnib) maintenance therapy to observation only with respect to disease-free survival (DFS) in patients with AML in second or subsequent complete remission or in complete response (CR) following primary induction failure.

SECONDARY OBJECTIVES:

I. To compare overall survival of patients in both arms. II. To evaluate the long-term safety and toxicity of extended administration of R115777 in AML patients in remission.

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

ARM A: Patients receive tipifarnib orally (PO) twice daily (BID) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients undergo observation only.

After completion of study treatment, patients are followed up for 5 years.

Conditions

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Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome Adult Acute Megakaryoblastic Leukemia Adult Acute Monocytic Leukemia Adult Acute Myeloid Leukemia in Remission Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 Adult Acute Myeloid Leukemia With Maturation Adult Acute Myeloid Leukemia With Minimal Differentiation Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11 Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1 Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A Adult Acute Myeloid Leukemia Without Maturation Adult Acute Myelomonocytic Leukemia Adult Erythroleukemia Adult Pure Erythroid Leukemia Alkylating Agent-Related Acute Myeloid Leukemia Myelodysplastic Syndrome With Excess Blasts Recurrent Adult Acute Myeloid Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A (tipifarnib)

Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

Tipifarnib

Intervention Type DRUG

Given PO

Arm B (clinical observation)

Patients undergo observation only.

Group Type OTHER

Clinical Observation

Intervention Type PROCEDURE

Undergo observation

Interventions

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Clinical Observation

Undergo observation

Intervention Type PROCEDURE

Tipifarnib

Given PO

Intervention Type DRUG

Other Intervention Names

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observation R115777 Zarnestra

Eligibility Criteria

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Inclusion Criteria

* Patients eligible to enter this study must fall into one of these categories:

* Patients in first remission following primary induction failure
* Patients must have received at least two chemotherapy induction regimens
* Patients in second or subsequent remission
* Patients \> 60 years old in first remission
* Patients must be in complete remission (CR) or morphologic remission (MR) by blood counts and bone marrow studies to enter the study

* Confirmatory bone marrow must be performed =\< 2 weeks prior to randomization
* Patients must have morphologic proof (from bone marrow aspirate, smears or touch preps of marrow biopsy) that they had AML of one of the following types prior to achievement of CR/MR

* Acute myeloblastic leukemia, minimal differentiation (French-American-British \[FAB\] M0)
* Acute myeloblastic leukemia without differentiation (FAB M1)
* Acute myeloblastic leukemia with maturation (FAB M2)
* Acute myelomonocytic leukemia (FAB M4)
* Acute monocytic leukemia (FAB M5)
* Acute erythroleukemia (FAB M6)
* Acute megakaryocytic leukemia (FAB M7)
* Refractory anemia with excess blasts in transformation (RAEB-T)
* AML by World Health Organization (WHO) criteria
* Acute myeloid leukemia with multilineage dysplasia
* Patients with acute promyelocytic leukemia (FAB M3) are not eligible
* Patients must be registered within 60 days of completion of therapy for the current remission; patients are eligible if they meet any of the criteria below:

* Within 60 days of remission (CR or MR) by peripheral blood counts following induction therapy or
* Within 60 days of discharge from the hospital following induction therapy or
* Within 60 days of discharge from the hospital following post-remission therapy or
* Within 60 days of recovery of blood counts following last dose of chemotherapy
* All of the patients below are eligible for study entry:

* Patients who have received consolidation therapy
* Patients who have not received any consolidation or post remission therapy
* Patients who have had an autologous stem cell transplant
* Patients who have received an allogeneic transplant (bone marrow transplant \[BMT\] or peripheral stem cell transplant \[PSCT\]) in their current remission are ineligible; patients who have had an allogeneic transplant in a previous remission and are currently in remission after subsequent relapse are eligible
* Patients with a history of extramedullary disease are eligible if they are in complete remission at the time of study entry and no longer requiring therapy for their extramedullary disease
* Patients must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study \< 2 weeks prior to randomization to rule out pregnancy
* Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception
* Patients must not be known to have an allergy to imidazole drugs, such as clotrimazole ketoconazole, miconazole, econazole, or terconazole; this does not include fluconazole, voriconazole, or itraconazole
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
* Patients must not have active cardiac or pulmonary disease; but patient will be eligible if disease is medically controlled
* Patients must not have active renal disease; creatinine must be =\< 1.5 x upper limit of normal
* Patients must not have active hepatic disease; total or direct bilirubin must be \< 2 mg/dl
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) must be =\< 2.5 times the upper limit of normal
* Absolute neutrophil count (ANC) \>= 1000/mm\^3
* Platelet count \>= 50,000/mm\^3
* Patients must not be taking a hepatic enzyme-inducing anti-convulsant; a patient will not be eligible for the study if the patient is currently taking one of these agents and cannot be switched to a non-hepatic enzyme-inducing anti-convulsant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Selina Luger

Role: PRINCIPAL_INVESTIGATOR

ECOG-ACRIN Cancer Research Group

Locations

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University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Site Status

Providence Alaska Medical Center

Anchorage, Alaska, United States

Site Status

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Kaiser Permanente-San Diego Mission

San Diego, California, United States

Site Status

The Medical Center of Aurora

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Site Status

Porter Adventist Hospital

Denver, Colorado, United States

Site Status

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Site Status

SCL Health Saint Joseph Hospital

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

Colorado Cancer Research Program NCORP

Denver, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

Poudre Valley Hospital

Fort Collins, Colorado, United States

Site Status

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

Saint Anthony Hospital

Lakewood, Colorado, United States

Site Status

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Site Status

Longmont United Hospital

Longmont, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Site Status

North Suburban Medical Center

Thornton, Colorado, United States

Site Status

SCL Health Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, United States

Site Status

Beebe Medical Center

Lewes, Delaware, United States

Site Status

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Site Status

Saint Francis Hospital - Wilmington

Wilmington, Delaware, United States

Site Status

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Boca Raton Regional Hospital

Boca Raton, Florida, United States

Site Status

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Site Status

Broward Health Medical Center

Fort Lauderdale, Florida, United States

Site Status

University of Florida Health Science Center - Gainesville

Gainesville, Florida, United States

Site Status

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Site Status

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Site Status

Jupiter Medical Center

Jupiter, Florida, United States

Site Status

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Site Status

Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status

Phoebe Putney Memorial Hospital

Albany, Georgia, United States

Site Status

University Cancer and Blood Center LLC

Athens, Georgia, United States

Site Status

Augusta University Medical Center

Augusta, Georgia, United States

Site Status

Memorial University Medical Center

Savannah, Georgia, United States

Site Status

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Site Status

Hematology Oncology Associates of Eastern Idaho

Idaho Falls, Idaho, United States

Site Status

Rush - Copley Medical Center

Aurora, Illinois, United States

Site Status

Saint Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital Association

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

Hematology and Oncology Associates

Chicago, Illinois, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Jesse Brown Veterans Affairs Medical Center

Chicago, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Mercy Hospital and Medical Center

Chicago, Illinois, United States

Site Status

Swedish Covenant Hospital

Chicago, Illinois, United States

Site Status

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Site Status

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status

Heartland Cancer Research NCORP

Decatur, Illinois, United States

Site Status

Eureka Hospital

Eureka, Illinois, United States

Site Status

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Site Status

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hinsdale Hematology Oncology Associates Incorporated

Hinsdale, Illinois, United States

Site Status

Hopedale Medical Complex - Hospital

Hopedale, Illinois, United States

Site Status

Midwest Center for Hematology Oncology

Joliet, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates Limited

Joliet, Illinois, United States

Site Status

Kewanee Hospital

Kewanee, Illinois, United States

Site Status

Deerpath Medical Associates

Lake Forest, Illinois, United States

Site Status

NorthShore Hematology Oncology-Libertyville

Libertyville, Illinois, United States

Site Status

Mcdonough District Hospital

Macomb, Illinois, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Illinois Cancer Specialists-Niles

Niles, Illinois, United States

Site Status

Bromenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center Foundation

Normal, Illinois, United States

Site Status

Franciscan St. James Health-Olympia Fields Campus

Olympia Fields, Illinois, United States

Site Status

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status

Ottawa Regional Hospital and Healthcare Center

Ottawa, Illinois, United States

Site Status

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

Pekin, Illinois, United States

Site Status

Pekin Hospital

Pekin, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois Valley Hospital

Peru, Illinois, United States

Site Status

Valley Radiation Oncology

Peru, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

Sarah Culbertson Memorial Hospital

Rushville, Illinois, United States

Site Status

Edward H Kaplan MD and Associates

Skokie, Illinois, United States

Site Status

Hematology Oncology Associates of Illinois - Skokie

Skokie, Illinois, United States

Site Status

Midwest Cancer Research Group Incorporated

Skokie, Illinois, United States

Site Status

Saint Margaret's Hospital

Spring Valley, Illinois, United States

Site Status

Memorial Medical Center

Springfield, Illinois, United States

Site Status

Carle Cancer Center

Urbana, Illinois, United States

Site Status

Franciscan Saint Francis Health-Beech Grove

Beech Grove, Indiana, United States

Site Status

Elkhart General Hospital

Elkhart, Indiana, United States

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Fort Wayne Medical Oncology and Hematology Inc-Parkview

Fort Wayne, Indiana, United States

Site Status

Community Howard Regional Health

Kokomo, Indiana, United States

Site Status

IU Health La Porte Hospital

La Porte, Indiana, United States

Site Status

Franciscan Saint Anthony Health-Michigan City

Michigan City, Indiana, United States

Site Status

Saint Joseph Regional Medical Center-Mishawaka

Mishawaka, Indiana, United States

Site Status

The Community Hospital

Munster, Indiana, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

Northern Indiana Cancer Research Consortium

South Bend, Indiana, United States

Site Status

McFarland Clinic PC-William R Bliss Cancer Center

Ames, Iowa, United States

Site Status

University of Iowa Healthcare Cancer Services Quad Cities

Bettendorf, Iowa, United States

Site Status

Medical Oncology and Hematology Associates-West Des Moines

Clive, Iowa, United States

Site Status

Heartland Oncology and Hematology LLP

Council Bluffs, Iowa, United States

Site Status

Genesis Medical Center - East Campus

Davenport, Iowa, United States

Site Status

Genesis Medical Center - West Campus

Davenport, Iowa, United States

Site Status

Mercy Capitol

Des Moines, Iowa, United States

Site Status

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Site Status

Iowa-Wide Oncology Research Coalition NCORP

Des Moines, Iowa, United States

Site Status

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, United States

Site Status

Medical Oncology and Hematology Associates-Laurel

Des Moines, Iowa, United States

Site Status

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

Site Status

Iowa Lutheran Hospital

Des Moines, Iowa, United States

Site Status

Siouxland Regional Cancer Center

Sioux City, Iowa, United States

Site Status

Mercy Medical Center-Sioux City

Sioux City, Iowa, United States

Site Status

Saint Luke's Regional Medical Center

Sioux City, Iowa, United States

Site Status

Hospital District Sixth of Harper County

Anthony, Kansas, United States

Site Status

Memorial Hospital of Arkansas City

Arkansas City, Kansas, United States

Site Status

Cancer Center of Kansas - Chanute

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas - El Dorado

El Dorado, Kansas, United States

Site Status

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, United States

Site Status

Cancer Center of Kansas-Independence

Independence, Kansas, United States

Site Status

Cancer Center of Kansas-Kingman

Kingman, Kansas, United States

Site Status

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status

Southwest Medical Center

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas - Newton

Newton, Kansas, United States

Site Status

Cancer Center of Kansas - Ottawa

Ottawa, Kansas, United States

Site Status

Menorah Medical Center

Overland Park, Kansas, United States

Site Status

Saint Luke's South Hospital

Overland Park, Kansas, United States

Site Status

Cancer Center of Kansas - Parsons

Parsons, Kansas, United States

Site Status

Kansas City NCI Community Oncology Research Program

Prairie Village, Kansas, United States

Site Status

Cancer Center of Kansas - Pratt

Pratt, Kansas, United States

Site Status

Cancer Center of Kansas - Salina

Salina, Kansas, United States

Site Status

Shawnee Mission Medical Center-KCCC

Shawnee Mission, Kansas, United States

Site Status

Cotton O'Neil Cancer Center / Stormont Vail Health

Topeka, Kansas, United States

Site Status

Saint Francis Hospital and Medical Center - Topeka

Topeka, Kansas, United States

Site Status

Cancer Center of Kansas - Wellington

Wellington, Kansas, United States

Site Status

Associates In Womens Health

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas - Wichita

Wichita, Kansas, United States

Site Status

Via Christi Regional Medical Center

Wichita, Kansas, United States

Site Status

Wichita NCI Community Oncology Research Program

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas - Winfield

Winfield, Kansas, United States

Site Status

Baton Rouge General Medical Center

Baton Rouge, Louisiana, United States

Site Status

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Site Status

Ochsner Health Center-Summa

Baton Rouge, Louisiana, United States

Site Status

Mary Bird Perkins Cancer Center/Terrebonne General Medical Center

Houma, Louisiana, United States

Site Status

Louisiana State University Health Science Center

New Orleans, Louisiana, United States

Site Status

University Medical Center New Orleans

New Orleans, Louisiana, United States

Site Status

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

Site Status

Overton Brooks Veteran's Administration Medical Center

Shreveport, Louisiana, United States

Site Status

Louisiana State University Health Sciences Center Shreveport

Shreveport, Louisiana, United States

Site Status

Eastern Maine Medical Center

Bangor, Maine, United States

Site Status

Maine General Medical Center-Thayer

Waterville, Maine, United States

Site Status

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Site Status

Union Hospital of Cecil County

Elkton, Maryland, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Site Status

Franklin Medical Center

Greenfield, Massachusetts, United States

Site Status

Baystate Medical Center

Springfield, Massachusetts, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Borgess Medical Center

Kalamazoo, Michigan, United States

Site Status

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status

Kalamazoo Center for Medical Studies

Kalamazoo, Michigan, United States

Site Status

William Beaumont Hospital-Royal Oak

Royal Oak, Michigan, United States

Site Status

Lakeland Hospital

Saint Joseph, Michigan, United States

Site Status

Providence Hospital-Southfield Cancer Center

Southfield, Michigan, United States

Site Status

Medini, Eitan MD (UIA Investigator)

Alexandria, Minnesota, United States

Site Status

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Site Status

Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status

Essentia Health Cancer Center

Duluth, Minnesota, United States

Site Status

Essentia Health Saint Mary's Medical Center

Duluth, Minnesota, United States

Site Status

Miller-Dwan Hospital

Duluth, Minnesota, United States

Site Status

Fairview-Southdale Hospital

Edina, Minnesota, United States

Site Status

Etzell, Paul S MD (UIA Investigator)

Fergus Falls, Minnesota, United States

Site Status

Swenson, Wade II, MD (UIA Investigator)

Fergus Falls, Minnesota, United States

Site Status

Unity Hospital

Fridley, Minnesota, United States

Site Status

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Site Status

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, United States

Site Status

Saint Cloud Hospital

Saint Cloud, Minnesota, United States

Site Status

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Site Status

United Hospital

Saint Paul, Minnesota, United States

Site Status

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

Site Status

Ridgeview Medical Center

Waconia, Minnesota, United States

Site Status

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Site Status

Hattiesburg Clinic - Hematology/Oncology Clinic

Hattiesburg, Mississippi, United States

Site Status

Hematology and Oncology Clinic

Hattiesburg, Mississippi, United States

Site Status

Centerpoint Medical Center LLC

Independence, Missouri, United States

Site Status

Truman Medical Center

Kansas City, Missouri, United States

Site Status

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Site Status

Saint Joseph Health Center

Kansas City, Missouri, United States

Site Status

North Kansas City Hospital

Kansas City, Missouri, United States

Site Status

Research Medical Center

Kansas City, Missouri, United States

Site Status

Saint Luke's East - Lee's Summit

Lee's Summit, Missouri, United States

Site Status

Liberty Radiation Oncology Center

Liberty, Missouri, United States

Site Status

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status

Northern Rockies Radiation Oncology Center

Billings, Montana, United States

Site Status

Saint Vincent Healthcare

Billings, Montana, United States

Site Status

Montana Cancer Consortium NCORP

Billings, Montana, United States

Site Status

Saint Vincent Frontier Cancer Center

Billings, Montana, United States

Site Status

Deaconess Medical Center

Billings, Montana, United States

Site Status

Bozeman Deaconess Hospital

Bozeman, Montana, United States

Site Status

Internal Medicine of Bozeman

Bozeman, Montana, United States

Site Status

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, United States

Site Status

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, United States

Site Status

Berdeaux, Donald MD (UIA Investigator)

Great Falls, Montana, United States

Site Status

Great Falls Clinic

Great Falls, Montana, United States

Site Status

Saint Peter's Community Hospital

Helena, Montana, United States

Site Status

Glacier Oncology PLLC

Kalispell, Montana, United States

Site Status

Kalispell Medical Oncology

Kalispell, Montana, United States

Site Status

Kalispell Regional Medical Center

Kalispell, Montana, United States

Site Status

Eastern Montana Cancer Center

Miles City, Montana, United States

Site Status

Montana Cancer Specialists

Missoula, Montana, United States

Site Status

Saint Patrick Hospital - Community Hospital

Missoula, Montana, United States

Site Status

Community Medical Hospital

Missoula, Montana, United States

Site Status

Guardian Oncology and Center for Wellness

Missoula, Montana, United States

Site Status

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

Site Status

Nevada Cancer Research Foundation CCOP

Las Vegas, Nevada, United States

Site Status

Cooper Hospital University Medical Center

Camden, New Jersey, United States

Site Status

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Hematology Oncology Associates of Central New York-East Syracuse

East Syracuse, New York, United States

Site Status

Orange Regional Medical Center

Middletown, New York, United States

Site Status

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Site Status

Weill Medical College of Cornell University

New York, New York, United States

Site Status

Stony Brook University Medical Center

Stony Brook, New York, United States

Site Status

Montefiore Medical Center-Weiler Hospital

The Bronx, New York, United States

Site Status

Montefiore Medical Center-Wakefield Campus

The Bronx, New York, United States

Site Status

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Site Status

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, United States

Site Status

Wayne Memorial Hospital

Goldsboro, North Carolina, United States

Site Status

Wayne Radiation Oncology

Goldsboro, North Carolina, United States

Site Status

Kinston Medical Specialists PA

Kinston, North Carolina, United States

Site Status

Rutherford Hospital

Rutherfordton, North Carolina, United States

Site Status

Wilson Medical Center

Wilson, North Carolina, United States

Site Status

Summa Akron City Hospital/Cooper Cancer Center

Akron, Ohio, United States

Site Status

Akron General Medical Center

Akron, Ohio, United States

Site Status

Aultman Health Foundation

Canton, Ohio, United States

Site Status

The Jewish Hospital

Cincinnati, Ohio, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Samaritan North Health Center

Dayton, Ohio, United States

Site Status

Cleveland Clinic Cancer Center Independence

Independence, Ohio, United States

Site Status

Saint Rita's Medical Center

Lima, Ohio, United States

Site Status

Cleveland Clinic Wooster Family Health and Surgery Center

Wooster, Ohio, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Cancer Care Associates

Oklahoma City, Oklahoma, United States

Site Status

Natalie Warren Bryant Cancer Center at Saint Francis

Tulsa, Oklahoma, United States

Site Status

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Lewistown Hospital

Lewistown, Pennsylvania, United States

Site Status

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Mercy Hospital

Scranton, Pennsylvania, United States

Site Status

Scranton Hematology Oncology

Scranton, Pennsylvania, United States

Site Status

Geisinger Medical Group

State College, Pennsylvania, United States

Site Status

Mount Nittany Medical Center

State College, Pennsylvania, United States

Site Status

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Site Status

WellSpan Health-York Hospital

York, Pennsylvania, United States

Site Status

AnMed Health Hospital

Anderson, South Carolina, United States

Site Status

McLeod Regional Medical Center

Florence, South Carolina, United States

Site Status

Spartanburg Medical Center

Spartanburg, South Carolina, United States

Site Status

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States

Site Status

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Site Status

Avera McKennan Hospital and University Health Center

Sioux Falls, South Dakota, United States

Site Status

Medical X-Ray Center

Sioux Falls, South Dakota, United States

Site Status

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Site Status

University of Tennessee - Knoxville

Knoxville, Tennessee, United States

Site Status

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Site Status

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, United States

Site Status

Baylor Saint Luke's Medical Center

Houston, Texas, United States

Site Status

Ben Taub General Hospital

Houston, Texas, United States

Site Status

Michael E DeBakey VA Medical Center

Houston, Texas, United States

Site Status

The Methodist Hospital System

Houston, Texas, United States

Site Status

Wilford Hall Medical Center

Lackland Air Force Base, Texas, United States

Site Status

Sandra L Maxwell Cancer Center

Cedar City, Utah, United States

Site Status

Logan Regional Hospital

Logan, Utah, United States

Site Status

Cottonwood Hospital Medical Center

Murray, Utah, United States

Site Status

Intermountain Medical Center

Murray, Utah, United States

Site Status

McKay-Dee Hospital Center

Ogden, Utah, United States

Site Status

Utah Valley Regional Medical Center

Provo, Utah, United States

Site Status

Intermountain Health Care

Salt Lake City, Utah, United States

Site Status

Utah Cancer Specialists-Salt Lake City

Salt Lake City, Utah, United States

Site Status

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Site Status

LDS Hospital

Salt Lake City, Utah, United States

Site Status

Dixie Medical Center Regional Cancer Center

St. George, Utah, United States

Site Status

Central Vermont Medical Center/National Life Cancer Treatment

Berlin Corners, Vermont, United States

Site Status

University of Vermont College of Medicine

Burlington, Vermont, United States

Site Status

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, United States

Site Status

Harrison HealthPartners Hematology and Oncology-Bremerton

Bremerton, Washington, United States

Site Status

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, United States

Site Status

Skagit Valley Hospital

Mount Vernon, Washington, United States

Site Status

Harborview Medical Center

Seattle, Washington, United States

Site Status

Minor and James Medical PLLC

Seattle, Washington, United States

Site Status

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Kaiser Permanente Washington

Seattle, Washington, United States

Site Status

Swedish Medical Center-First Hill

Seattle, Washington, United States

Site Status

University of Washington Medical Center

Seattle, Washington, United States

Site Status

PeaceHealth United General Medical Center

Sedro-Woolley, Washington, United States

Site Status

Cancer Care Northwest - Spokane South

Spokane, Washington, United States

Site Status

PeaceHealth Southwest Medical Center

Vancouver, Washington, United States

Site Status

Central Washington Hospital

Wenatchee, Washington, United States

Site Status

Wenatchee Valley Hospital and Clinics

Wenatchee, Washington, United States

Site Status

West Virginia University Healthcare

Morgantown, West Virginia, United States

Site Status

Marshfield Clinic-Chippewa Center

Chippewa Falls, Wisconsin, United States

Site Status

Marshfield Clinic Cancer Center at Sacred Heart

Eau Claire, Wisconsin, United States

Site Status

Sacred Heart Hospital

Eau Claire, Wisconsin, United States

Site Status

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status

Marshfield Clinic

Marshfield, Wisconsin, United States

Site Status

Marshfield Medical Center

Marshfield, Wisconsin, United States

Site Status

Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, United States

Site Status

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, United States

Site Status

Ascension Saint Mary's Hospital

Rhinelander, Wisconsin, United States

Site Status

Marshfield Clinic-Rice Lake Center

Rice Lake, Wisconsin, United States

Site Status

Saint Michael's Hospital

Stevens Point, Wisconsin, United States

Site Status

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, United States

Site Status

Marshfield Clinic-Wausau Center

Wausau, Wisconsin, United States

Site Status

Diagnostic and Treatment Center

Weston, Wisconsin, United States

Site Status

Marshfield Clinic - Weston Center

Weston, Wisconsin, United States

Site Status

Marshfield Clinic - Wisconsin Rapids Center

Wisconsin Rapids, Wisconsin, United States

Site Status

Welch Cancer Center

Sheridan, Wyoming, United States

Site Status

Rambam Medical Center

Haifa, , Israel

Site Status

Instituto Nacional de Enfermedades Neoplasicas

Lima, , Peru

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Israel Peru

Related Links

Access external resources that provide additional context or updates about the study.

https://nctn-data-archive.nci.nih.gov/

Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2009-00535

Identifier Type: REGISTRY

Identifier Source: secondary_id

E2902

Identifier Type: -

Identifier Source: secondary_id

E2902

Identifier Type: OTHER

Identifier Source: secondary_id

E2902

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180820

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10CA021115

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00535

Identifier Type: -

Identifier Source: org_study_id

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