Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Adult Acute Megakaryoblastic Leukemia, Adult Acute Monocytic Leukemia
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Eligibility 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
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Providence Alaska Medical Center
- Mayo Clinic in Arizona
- Kaiser Permanente-San Diego Mission
- The Medical Center of Aurora
- Boulder Community Hospital
- Penrose-Saint Francis Healthcare
- Porter Adventist Hospital
- Presbyterian - Saint Lukes Medical Center - Health One
- SCL Health Saint Joseph Hospital
- Rose Medical Center
- Colorado Cancer Research Program NCORP
- Swedish Medical Center
- Poudre Valley Hospital
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Saint Anthony Hospital
- Sky Ridge Medical Center
- Longmont United Hospital
- McKee Medical Center
- Saint Mary Corwin Medical Center
- North Suburban Medical Center
- SCL Health Lutheran Medical Center
- Smilow Cancer Hospital-Torrington Care Center
- Beebe Medical Center
- Christiana Care Health System-Christiana Hospital
- Saint Francis Hospital - Wilmington
- MedStar Georgetown University Hospital
- MedStar Washington Hospital Center
- Boca Raton Regional Hospital
- Holy Cross Hospital
- Broward Health Medical Center
- University of Florida Health Science Center - Gainesville
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
- Baptist MD Anderson Cancer Center
- Jupiter Medical Center
- Mount Sinai Medical Center
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Phoebe Putney Memorial Hospital
- University Cancer and Blood Center LLC
- Augusta University Medical Center
- Memorial University Medical Center
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Hematology Oncology Associates of Eastern Idaho
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Graham Hospital Association
- Memorial Hospital
- Hematology and Oncology Associates
- Northwestern University
- Jesse Brown Veterans Affairs Medical Center
- Rush University Medical Center
- Mercy Hospital and Medical Center
- Swedish Covenant Hospital
- University of Chicago Comprehensive Cancer Center
- Decatur Memorial Hospital
- Heartland Cancer Research NCORP
- Eureka Hospital
- NorthShore University HealthSystem-Evanston Hospital
- Galesburg Cottage Hospital
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Mason District Hospital
- Hinsdale Hematology Oncology Associates Incorporated
- Hopedale Medical Complex - Hospital
- Midwest Center for Hematology Oncology
- Joliet Oncology-Hematology Associates Limited
- Kewanee Hospital
- Deerpath Medical Associates
- NorthShore Hematology Oncology-Libertyville
- Mcdonough District Hospital
- Loyola University Medical Center
- Illinois Cancer Specialists-Niles
- Bromenn Regional Medical Center
- Community Cancer Center Foundation
- Franciscan St. James Health-Olympia Fields Campus
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Pekin Hospital
- Methodist Medical Center of Illinois
- Proctor Hospital
- Illinois CancerCare-Peoria
- OSF Saint Francis Medical Center
- Illinois Valley Hospital
- Valley Radiation Oncology
- Perry Memorial Hospital
- Sarah Culbertson Memorial Hospital
- Edward H Kaplan MD and Associates
- Hematology Oncology Associates of Illinois - Skokie
- Midwest Cancer Research Group Incorporated
- Saint Margaret's Hospital
- Memorial Medical Center
- Carle Cancer Center
- Franciscan Saint Francis Health-Beech Grove
- Elkhart General Hospital
- Fort Wayne Medical Oncology and Hematology Inc-Parkview
- Community Howard Regional Health
- IU Health La Porte Hospital
- Franciscan Saint Anthony Health-Michigan City
- Saint Joseph Regional Medical Center-Mishawaka
- The Community Hospital
- Memorial Hospital of South Bend
- Northern Indiana Cancer Research Consortium
- McFarland Clinic PC-William R Bliss Cancer Center
- University of Iowa Healthcare Cancer Services Quad Cities
- Medical Oncology and Hematology Associates-West Des Moines
- Heartland Oncology and Hematology LLP
- Genesis Medical Center - East Campus
- Genesis Medical Center - West Campus
- Mercy Capitol
- Iowa Methodist Medical Center
- Iowa-Wide Oncology Research Coalition NCORP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- Siouxland Regional Cancer Center
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Hospital District Sixth of Harper County
- Memorial Hospital of Arkansas City
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Southwest Medical Center
- Cancer Center of Kansas - Newton
- Cancer Center of Kansas - Ottawa
- Menorah Medical Center
- Saint Luke's South Hospital
- Cancer Center of Kansas - Parsons
- Kansas City NCI Community Oncology Research Program
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Shawnee Mission Medical Center-KCCC
- Cotton O'Neil Cancer Center / Stormont Vail Health
- Saint Francis Hospital and Medical Center - Topeka
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Wichita
- Via Christi Regional Medical Center
- Wichita NCI Community Oncology Research Program
- Cancer Center of Kansas - Winfield
- Baton Rouge General Medical Center
- Mary Bird Perkins Cancer Center
- Ochsner Health Center-Summa
- Mary Bird Perkins Cancer Center/Terrebonne General Medical Center
- Louisiana State University Health Science Center
- University Medical Center New Orleans
- Ochsner Medical Center Jefferson
- Overton Brooks Veteran's Administration Medical Center
- Louisiana State University Health Sciences Center Shreveport
- Eastern Maine Medical Center
- Maine General Medical Center-Thayer
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Union Hospital of Cecil County
- Tufts Medical Center
- Boston Medical Center
- Lahey Hospital and Medical Center
- Franklin Medical Center
- Baystate Medical Center
- Henry Ford Hospital
- Borgess Medical Center
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Kalamazoo Center for Medical Studies
- William Beaumont Hospital-Royal Oak
- Lakeland Hospital
- Providence Hospital-Southfield Cancer Center
- Medini, Eitan MD (UIA Investigator)
- Fairview Ridges Hospital
- Mercy Hospital
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Fairview-Southdale Hospital
- Etzell, Paul S MD (UIA Investigator)
- Swenson, Wade II, MD (UIA Investigator)
- Unity Hospital
- Minnesota Oncology Hematology PA-Maplewood
- Abbott-Northwestern Hospital
- North Memorial Medical Health Center
- Mayo Clinic
- Coborn Cancer Center at Saint Cloud Hospital
- Saint Cloud Hospital
- Park Nicollet Clinic - Saint Louis Park
- United Hospital
- Saint Francis Regional Medical Center
- Ridgeview Medical Center
- Minnesota Oncology Hematology PA-Woodbury
- Hattiesburg Clinic - Hematology/Oncology Clinic
- Hematology and Oncology Clinic
- Centerpoint Medical Center LLC
- Truman Medical Center
- Saint Luke's Hospital of Kansas City
- Saint Joseph Health Center
- North Kansas City Hospital
- Research Medical Center
- Saint Luke's East - Lee's Summit
- Liberty Radiation Oncology Center
- Heartland Regional Medical Center
- Washington University School of Medicine
- Billings Clinic Cancer Center
- Northern Rockies Radiation Oncology Center
- Saint Vincent Healthcare
- Montana Cancer Consortium NCORP
- Saint Vincent Frontier Cancer Center
- Deaconess Medical Center
- Bozeman Deaconess Hospital
- Internal Medicine of Bozeman
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Berdeaux, Donald MD (UIA Investigator)
- Great Falls Clinic
- Saint Peter's Community Hospital
- Glacier Oncology PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Eastern Montana Cancer Center
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- Guardian Oncology and Center for Wellness
- University Medical Center of Southern Nevada
- Nevada Cancer Research Foundation CCOP
- Cooper Hospital University Medical Center
- Rutgers Cancer Institute of New Jersey
- Montefiore Medical Center-Weiler Hospital
- Montefiore Medical Center-Wakefield Campus
- Montefiore Medical Center - Moses Campus
- Roswell Park Cancer Institute
- Hematology Oncology Associates of Central New York-East Syracuse
- Orange Regional Medical Center
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- Weill Medical College of Cornell University
- Stony Brook University Medical Center
- Carolinas Medical Center/Levine Cancer Institute
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- Wayne Radiation Oncology
- Kinston Medical Specialists PA
- Rutherford Hospital
- Wilson Medical Center
- Summa Akron City Hospital/Cooper Cancer Center
- Akron General Medical Center
- Aultman Health Foundation
- The Jewish Hospital
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Samaritan North Health Center
- Cleveland Clinic Cancer Center Independence
- Saint Rita's Medical Center
- Cleveland Clinic Wooster Family Health and Surgery Center
- University of Oklahoma Health Sciences Center
- Cancer Care Associates
- Natalie Warren Bryant Cancer Center at Saint Francis
- Lehigh Valley Hospital-Cedar Crest
- Geisinger Medical Center
- Penn State Milton S Hershey Medical Center
- Lewistown Hospital
- University of Pennsylvania/Abramson Cancer Center
- Pennsylvania Hospital
- Fox Chase Cancer Center
- Mercy Hospital
- Scranton Hematology Oncology
- Geisinger Medical Group
- Mount Nittany Medical Center
- Geisinger Wyoming Valley/Henry Cancer Center
- WellSpan Health-York Hospital
- AnMed Health Hospital
- McLeod Regional Medical Center
- Spartanburg Medical Center
- Sanford Cancer Center Oncology Clinic
- Avera Cancer Institute
- Avera McKennan Hospital and University Health Center
- Medical X-Ray Center
- Sanford USD Medical Center - Sioux Falls
- University of Tennessee - Knoxville
- Brooke Army Medical Center
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- Baylor Saint Luke's Medical Center
- Ben Taub General Hospital
- Michael E DeBakey VA Medical Center
- The Methodist Hospital System
- Wilford Hall Medical Center
- Sandra L Maxwell Cancer Center
- Logan Regional Hospital
- Cottonwood Hospital Medical Center
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Dixie Medical Center Regional Cancer Center
- Intermountain Health Care
- Utah Cancer Specialists-Salt Lake City
- Huntsman Cancer Institute/University of Utah
- LDS Hospital
- Central Vermont Medical Center/National Life Cancer Treatment
- University of Vermont College of Medicine
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Kadlec Clinic Hematology and Oncology
- Skagit Valley Hospital
- Harborview Medical Center
- Minor and James Medical PLLC
- Fred Hutchinson Cancer Research Center
- Kaiser Permanente Washington
- Swedish Medical Center-First Hill
- University of Washington Medical Center
- PeaceHealth United General Medical Center
- Cancer Care Northwest - Spokane South
- PeaceHealth Southwest Medical Center
- Central Washington Hospital
- Wenatchee Valley Hospital and Clinics
- West Virginia University Healthcare
- Marshfield Clinic-Chippewa Center
- Marshfield Clinic Cancer Center at Sacred Heart
- Sacred Heart Hospital
- Gundersen Lutheran Medical Center
- Marshfield Clinic
- Marshfield Medical Center
- Froedtert and the Medical College of Wisconsin
- Marshfield Clinic-Minocqua Center
- ProHealth Oconomowoc Memorial Hospital
- Ascension Saint Mary's Hospital
- Marshfield Clinic-Rice Lake Center
- Saint Michael's Hospital
- ProHealth Waukesha Memorial Hospital
- Marshfield Clinic-Wausau Center
- Diagnostic and Treatment Center
- Marshfield Clinic - Weston Center
- Marshfield Clinic - Wisconsin Rapids Center
- Welch Cancer Center
- Rambam Medical Center
- Instituto Nacional de Enfermedades Neoplasicas
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Arm A (tipifarnib)
Arm B (clinical observation)
Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo observation only.