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NCT00093470

PHASE3

Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2004-08-18

Completion Date

2015-04-14

Last Updated

2026-07-14

Healthy Volunteers

Conditions

Interventions

PROCEDURE

Clinical Observation

Undergo observation

DRUG

Tipifarnib

Given PO

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

Locations (341)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Providence Alaska Medical Center

Anchorage, Alaska, United States

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Kaiser Permanente-San Diego Mission

San Diego, California, United States

The Medical Center of Aurora

Aurora, Colorado, United States

Boulder Community Hospital

Boulder, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Porter Adventist Hospital

Denver, Colorado, United States

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

SCL Health Saint Joseph Hospital

Denver, Colorado, United States

Rose Medical Center

Denver, Colorado, United States

Colorado Cancer Research Program NCORP

Denver, Colorado, United States

Swedish Medical Center

Englewood, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

North Colorado Medical Center

Greeley, Colorado, United States

Saint Anthony Hospital

Lakewood, Colorado, United States

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

McKee Medical Center

Loveland, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

North Suburban Medical Center

Thornton, Colorado, United States

SCL Health Lutheran Medical Center

Wheat Ridge, Colorado, United States

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, United States

Beebe Medical Center

Lewes, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Saint Francis Hospital - Wilmington

Wilmington, Delaware, United States

MedStar Georgetown University Hospital

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

MedStar Washington Hospital Center

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

Boca Raton Regional Hospital

Boca Raton, Florida, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Broward Health Medical Center

Fort Lauderdale, Florida, United States

University of Florida Health Science Center - Gainesville

Gainesville, Florida, United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Jupiter Medical Center

Jupiter, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

Phoebe Putney Memorial Hospital

Albany, Georgia, United States

University Cancer and Blood Center LLC

Athens, Georgia, United States

Augusta University Medical Center

Augusta, Georgia, United States

Memorial University Medical Center

Savannah, Georgia, United States

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

Savannah, Georgia, United States

Hematology Oncology Associates of Eastern Idaho

Idaho Falls, Idaho, United States

Rush - Copley Medical Center

Aurora, Illinois, United States

Saint Joseph Medical Center

Bloomington, Illinois, United States

Graham Hospital Association

Canton, Illinois, United States

Memorial Hospital

Carthage, Illinois, United States

Hematology and Oncology Associates