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Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission

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ClinicalTrials.gov Identifier: NCT00093470
Recruitment Status : Completed
First Posted : October 8, 2004
Results First Posted : November 10, 2015
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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 Procedure: Clinical Observation Drug: Tipifarnib Phase 3

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study of Farnesyl Transferase Inhibitor R115777 in Acute Myeloid Leukemia (AML) Patients in Second or Subsequent Remission or in Remission After Primary Induction Failure or Patients Over Age 60 in First Remission
Actual Study Start Date : August 18, 2004
Actual Primary Completion Date : February 20, 2015


Arm Intervention/treatment
Experimental: 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.
Drug: Tipifarnib
Given PO
Other Names:
  • R115777
  • Zarnestra
Arm B (clinical observation)
Patients undergo observation only.
Procedure: Clinical Observation
Undergo observation
Other Name: observation



Primary Outcome Measures :
  1. Disease-free Survival [ Time Frame: Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years. ]
    Disease-free survival (DFS) is defined as the time from randomization to relapse or death without relapse.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years. ]
    Overall survival (OS) is defined as the time from randomization to death from any cause.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00093470


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Locations
United States, Alabama
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
United States, Alaska
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, California
Kaiser Permanente-San Diego Mission
San Diego, California, United States, 92108
United States, Colorado
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
SCL Health Saint Joseph Hospital
Denver, Colorado, United States, 80218
Rose Medical Center
Denver, Colorado, United States, 80220
Colorado Cancer Research Program NCORP
Denver, Colorado, United States, 80222
Swedish Medical Center
Englewood, Colorado, United States, 80113
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States, 81501
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Saint Anthony Hospital
Lakewood, Colorado, United States, 80228
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thornton, Colorado, United States, 80229
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, United States, 06790
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
Saint Francis Hospital - Wilmington
Wilmington, Delaware, United States, 19805
United States, District of Columbia
MedStar Georgetown University Hospital
Washington, District of Columbia, United States, 20007
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Broward Health Medical Center
Fort Lauderdale, Florida, United States, 33316
University of Florida Health Science Center - Gainesville
Gainesville, Florida, United States, 32610
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
Jupiter Medical Center
Jupiter, Florida, United States, 33458
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
United States, Georgia
Phoebe Putney Memorial Hospital
Albany, Georgia, United States, 31701
University Cancer and Blood Center LLC
Athens, Georgia, United States, 30607
Augusta University Medical Center
Augusta, Georgia, United States, 30912
Memorial University Medical Center
Savannah, Georgia, United States, 31404
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Idaho
Hematology Oncology Associates of Eastern Idaho
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Graham Hospital Association
Canton, Illinois, United States, 61520
Memorial Hospital
Carthage, Illinois, United States, 62321
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
Northwestern University
Chicago, Illinois, United States, 60611
Jesse Brown Veterans Affairs Medical Center
Chicago, Illinois, United States, 60612
Rush University Medical Center
Chicago, Illinois, United States, 60612
Mercy Hospital and Medical Center
Chicago, Illinois, United States, 60616
Swedish Covenant Hospital
Chicago, Illinois, United States, 60625
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Heartland Cancer Research NCORP
Decatur, Illinois, United States, 62526
Eureka Hospital
Eureka, Illinois, United States, 61530
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States, 61401
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States, 61401
Mason District Hospital
Havana, Illinois, United States, 62644
Hinsdale Hematology Oncology Associates Incorporated
Hinsdale, Illinois, United States, 60521
Hopedale Medical Complex - Hospital
Hopedale, Illinois, United States, 61747
Midwest Center for Hematology Oncology
Joliet, Illinois, United States, 60432
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, United States, 60435
Kewanee Hospital
Kewanee, Illinois, United States, 61443
Deerpath Medical Associates
Lake Forest, Illinois, United States, 60045
NorthShore Hematology Oncology-Libertyville
Libertyville, Illinois, United States, 60048
Mcdonough District Hospital
Macomb, Illinois, United States, 61455
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Illinois Cancer Specialists-Niles
Niles, Illinois, United States, 60714
Bromenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center Foundation
Normal, Illinois, United States, 61761
Franciscan St. James Health-Olympia Fields Campus
Olympia Fields, Illinois, United States, 60461
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States, 61350
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Pekin Hospital
Pekin, Illinois, United States, 61554
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Proctor Hospital
Peoria, Illinois, United States, 61614
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois Valley Hospital
Peru, Illinois, United States, 61354
Valley Radiation Oncology
Peru, Illinois, United States, 61354
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Sarah Culbertson Memorial Hospital
Rushville, Illinois, United States, 62681
Edward H Kaplan MD and Associates
Skokie, Illinois, United States, 60076
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, United States, 60076
Midwest Cancer Research Group Incorporated
Skokie, Illinois, United States, 60077
Saint Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Memorial Medical Center
Springfield, Illinois, United States, 62781
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Franciscan Saint Francis Health-Beech Grove
Beech Grove, Indiana, United States, 46107
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, United States, 46845
Community Howard Regional Health
Kokomo, Indiana, United States, 46904
IU Health La Porte Hospital
La Porte, Indiana, United States, 46350
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States, 46360
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States, 46545
The Community Hospital
Munster, Indiana, United States, 46321
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46628
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, United States, 52722
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Heartland Oncology and Hematology LLP
Council Bluffs, Iowa, United States, 51503
Genesis Medical Center - East Campus
Davenport, Iowa, United States, 52803
Genesis Medical Center - West Campus
Davenport, Iowa, United States, 52804
Mercy Capitol
Des Moines, Iowa, United States, 50307
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kansas
Hospital District Sixth of Harper County
Anthony, Kansas, United States, 67003
Memorial Hospital of Arkansas City
Arkansas City, Kansas, United States, 67005
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Southwest Medical Center
Liberal, Kansas, United States, 67901
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas - Ottawa
Ottawa, Kansas, United States, 66067
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Saint Luke's South Hospital
Overland Park, Kansas, United States, 66213
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, United States, 66208
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Shawnee Mission Medical Center-KCCC
Shawnee Mission, Kansas, United States, 66204
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka, Kansas, United States, 66606
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, United States, 66606
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Associates In Womens Health
Wichita, Kansas, United States, 67208
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States, 67214
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wichita NCI Community Oncology Research Program
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Louisiana
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States, 70806
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
Ochsner Health Center-Summa
Baton Rouge, Louisiana, United States, 70809
Mary Bird Perkins Cancer Center/Terrebonne General Medical Center
Houma, Louisiana, United States, 70360
Louisiana State University Health Science Center
New Orleans, Louisiana, United States, 70112
University Medical Center New Orleans
New Orleans, Louisiana, United States, 70112
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
Overton Brooks Veteran's Administration Medical Center
Shreveport, Louisiana, United States, 71101
Louisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana, United States, 71103
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Maine General Medical Center-Thayer
Waterville, Maine, United States, 04901
United States, Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Union Hospital of Cecil County
Elkton, Maryland, United States, 21921
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Boston Medical Center
Boston, Massachusetts, United States, 02118
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
Franklin Medical Center
Greenfield, Massachusetts, United States, 01301
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Kalamazoo Center for Medical Studies
Kalamazoo, Michigan, United States, 49008
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Lakeland Hospital
Saint Joseph, Michigan, United States, 49085
Providence Hospital-Southfield Cancer Center
Southfield, Michigan, United States, 48075
United States, Minnesota
Medini, Eitan MD (UIA Investigator)
Alexandria, Minnesota, United States, 56308
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States, 55805
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Etzell, Paul S MD (UIA Investigator)
Fergus Falls, Minnesota, United States, 56537
Swenson, Wade II, MD (UIA Investigator)
Fergus Falls, Minnesota, United States, 56537
Unity Hospital
Fridley, Minnesota, United States, 55432
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic
Rochester, Minnesota, United States, 55905
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Mississippi
Hattiesburg Clinic - Hematology/Oncology Clinic
Hattiesburg, Mississippi, United States, 39401
Hematology and Oncology Clinic
Hattiesburg, Mississippi, United States, 39402
United States, Missouri
Centerpoint Medical Center LLC
Independence, Missouri, United States, 64057
Truman Medical Center
Kansas City, Missouri, United States, 64108
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Saint Joseph Health Center
Kansas City, Missouri, United States, 64114
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Research Medical Center
Kansas City, Missouri, United States, 64132
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Liberty Radiation Oncology Center
Liberty, Missouri, United States, 64068
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64507
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Montana
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Montana Cancer Consortium NCORP
Billings, Montana, United States, 59102
Saint Vincent Frontier Cancer Center
Billings, Montana, United States, 59102
Deaconess Medical Center
Billings, Montana, United States, 59107
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Internal Medicine of Bozeman
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, United States, 59405
Great Falls Clinic
Great Falls, Montana, United States, 59405
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Glacier Oncology PLLC
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Eastern Montana Cancer Center
Miles City, Montana, United States, 59301
Montana Cancer Specialists
Missoula, Montana, United States, 59802
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
Community Medical Hospital
Missoula, Montana, United States, 59804
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
United States, Nevada
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New York
Montefiore Medical Center-Weiler Hospital
Bronx, New York, United States, 10461
Montefiore Medical Center-Wakefield Campus
Bronx, New York, United States, 10466
Montefiore Medical Center - Moses Campus
Bronx, New York, United States, 10467
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, United States, 13057
Orange Regional Medical Center
Middletown, New York, United States, 10940
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Weill Medical College of Cornell University
New York, New York, United States, 10065
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, United States, 27534
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
Wayne Radiation Oncology
Goldsboro, North Carolina, United States, 27534
Kinston Medical Specialists PA
Kinston, North Carolina, United States, 28501
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
Wilson Medical Center
Wilson, North Carolina, United States, 27893
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Akron General Medical Center
Akron, Ohio, United States, 44307
Aultman Health Foundation
Canton, Ohio, United States, 44710
The Jewish Hospital
Cincinnati, Ohio, United States, 45236
Case Western Reserve University
Cleveland, Ohio, United States, 44106
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Samaritan North Health Center
Dayton, Ohio, United States, 45415
Cleveland Clinic Cancer Center Independence
Independence, Ohio, United States, 44131
Saint Rita's Medical Center
Lima, Ohio, United States, 45801
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio, United States, 44691
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Cancer Care Associates
Oklahoma City, Oklahoma, United States, 73120
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States, 18103
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Mercy Hospital
Scranton, Pennsylvania, United States, 18501
Scranton Hematology Oncology
Scranton, Pennsylvania, United States, 18510
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States, 18711
WellSpan Health-York Hospital
York, Pennsylvania, United States, 17403
United States, South Carolina
AnMed Health Hospital
Anderson, South Carolina, United States, 29621
McLeod Regional Medical Center
Florence, South Carolina, United States, 29506
Spartanburg Medical Center
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center
Sioux Falls, South Dakota, United States, 57105
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Tennessee
University of Tennessee - Knoxville
Knoxville, Tennessee, United States, 37920
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Baylor Saint Luke's Medical Center
Houston, Texas, United States, 77030
Ben Taub General Hospital
Houston, Texas, United States, 77030
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030
The Methodist Hospital System
Houston, Texas, United States, 77030
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States, 78236
United States, Utah
Sandra L Maxwell Cancer Center
Cedar City, Utah, United States, 84720
Logan Regional Hospital
Logan, Utah, United States, 84321
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
Intermountain Medical Center
Murray, Utah, United States, 84107
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center
Provo, Utah, United States, 84604
Dixie Medical Center Regional Cancer Center
Saint George, Utah, United States, 84770
Intermountain Health Care
Salt Lake City, Utah, United States, 84103
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, United States, 84106
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Vermont
Central Vermont Medical Center/National Life Cancer Treatment
Berlin, Vermont, United States, 05602
University of Vermont College of Medicine
Burlington, Vermont, United States, 05405
United States, Washington
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States, 98225
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, United States, 98310
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States, 99336
Skagit Valley Hospital
Mount Vernon, Washington, United States, 98274
Harborview Medical Center
Seattle, Washington, United States, 98104
Minor and James Medical PLLC
Seattle, Washington, United States, 98104
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Kaiser Permanente Washington
Seattle, Washington, United States, 98112
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
University of Washington Medical Center
Seattle, Washington, United States, 98195
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, United States, 98284
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States, 98664
Central Washington Hospital
Wenatchee, Washington, United States, 98801
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, United States, 98801
United States, West Virginia
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, United States, 54729
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States, 54701
Sacred Heart Hospital
Eau Claire, Wisconsin, United States, 54701
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Marshfield Medical Center
Marshfield, Wisconsin, United States, 54449
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States, 54548
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States, 53066
Ascension Saint Mary's Hospital
Rhinelander, Wisconsin, United States, 54501
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States, 54868
Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, United States, 53188
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, United States, 54401
Diagnostic and Treatment Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States, 54494
United States, Wyoming
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Israel
Rambam Medical Center
Haifa, Israel, 31096
Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima, Peru, Lima 34
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Selina Luger ECOG-ACRIN Cancer Research Group

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00093470     History of Changes
Other Study ID Numbers: NCI-2009-00535
NCI-2009-00535 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
E2902
E2902 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
E2902 ( Other Identifier: CTEP )
U10CA180820 ( U.S. NIH Grant/Contract )
U10CA021115 ( U.S. NIH Grant/Contract )
First Posted: October 8, 2004    Key Record Dates
Results First Posted: November 10, 2015
Last Update Posted: April 19, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Syndrome
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Leukemia, Monocytic, Acute
Leukemia, Myelomonocytic, Acute
Leukemia, Megakaryoblastic, Acute
Leukemia, Erythroblastic, Acute
Anemia, Refractory, with Excess of Blasts
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Myeloproliferative Disorders
Anemia, Refractory
Anemia
Tipifarnib
Antineoplastic Agents