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S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Southwest Oncology Group
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00840177
First received: February 7, 2009
Last updated: July 12, 2017
Last verified: July 2017
  Purpose

RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pravastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Pravastatin may also help idarubicin and cytarabine work better by making cancer cells more sensitive to the drugs. Giving idarubicin and cytarabine together with pravastatin may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving idarubicin and cytarabine together with pravastatin works in treating patients with relapsed acute myeloid leukemia.


Condition Intervention Phase
Leukemia Drug: cytarabine Drug: idarubicin Drug: pravastatin sodium Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: S0919, A Phase II Study of Idarubicin and Ara-C in Combination With Pravastatin for Relapsed Acute Myelogenous Leukemia (AML)

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Complete remission (CR) rate (including CR with incomplete recovery) [ Time Frame: 5 years ]
  • Relapse-free survival [ Time Frame: 5 years ]
  • Overall survival [ Time Frame: 5 years ]
  • Toxicity as assessed by NCI CTCAE version 4.0 [ Time Frame: 5 years ]
  • Correlation between pre-study cytogenetic features and response [ Time Frame: 5 years ]

Estimated Enrollment: 110
Study Start Date: August 2009
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment

Induction (1 cycle):

pravastatin 1280 mg/d PO D 1-8 idarubicin 12 mg/m2/d IV D 4-6 AraC 1.5 g/m2/d contIV D 4-7

Consolidation (up to 2 cycles):

pravastatin 1280 mg/d PO D 1-6 idarubicin 12 mg/m2/d IV D 4-5 AraC 1.5 g/m2/d contIV D 4-5

Drug: cytarabine Drug: idarubicin Drug: pravastatin sodium

Detailed Description:

OBJECTIVES:

  • To test whether the complete remission (CR) rate (including CR with incomplete recovery) in patients with relapsed acute myeloid leukemia treated with idarubicin and cytarabine in combination with pravastatin is sufficiently high to warrant a phase III investigation.
  • To estimate relapse-free survival and overall survival rates in these patients.
  • To estimate the frequency and severity of toxicities of this regimen in these patients.
  • To evaluate, in a preliminary manner, whether pre-study cytogenetic features correlate with response in these patients.

OUTLINE: This is a multicenter study.

  • Induction therapy: Patients receive oral pravastatin once daily on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Patients achieving complete remission proceed to consolidation therapy.
  • Consolidation therapy: Beginning 30-60 days after the start of induction therapy, patients receive oral pravastatin once daily on days 1-6 and idarubicin IV over 10-15 minutes and cytarabine IV continuously on days 4 and 5. Treatment repeats approximately every 5 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.

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

  Eligibility

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

Cohort 1 (MDS transformed to AML) is open to accrual

Cohort 2 (relapsed/refractory AML) is permanently closed to accrual

DISEASE CHARACTERISTICS:

  • For patients registered to relapsed/refractory (Cohort 2), morphologically confirmed diagnosis of acute myeloid leukemia (AML)
  • Patient registered to the MDS transformed to AML cohort (Cohort 1) patients must have a previous morphologically confirmed diagnosis of MDS/CMML. Patients may have received previous non-intensive therapy (such as: azacitadine, decitabine, low-dose cytarabine, lenalidomide) given treatment of MDS/CMML (with up to 20% blasts). At time of registration, patient must have morphologically confirmed diagnosis of AML.
  • Patients with acute promyelocytic leukemia (i.e., APL, FAB M3) or blastic transformation of chronic myelogenous leukemia are not eligible
  • Patients mus not have received autologous or allogeneic stem cell transplant.
  • Patients in the relapsed/refractory AML cohort (Cohort 2) must:

    • Have received ≥ 1 prior chemotherapy regimen for AML

      • Any type of prior chemotherapy allowed
      • Administration of hydroxyurea to control high WBC prior to, during, and after registration is permitted
    • Relapse must be documented by a bone marrow examination demonstrating > 5% blasts in the bone marrow not attributable to another cause
    • Patient must not have received chemo within 14 days prior to registration
  • Primary refractory patients eligible if, on Day 14 of previous chemo regimen, they have significant residual disease. Patients who received only hypomethylating agent or low dose therapy for Induction are not considered primary refractory for this study and are not eligible.
  • Relapsed patients must have achieved a complete remission (CR) or CR with incomplete blood count recovery that lasted < 6 months after the last induction regimen
  • No clinical evidence of leptomeningeal disease
  • Pretreatment (collected within 28 days of registration) cytogenetics must be performed on all patients.
  • Patients must have complete history and physical exam within 28 days prior to registration.

PATIENT CHARACTERISTICS:

  • No symptomatic congestive heart failure, coronary artery disease, cardiomyopathy, or uncontrolled arrhythmias

    • Ejection fraction ≥ 45% by echocardiogram or MUGA scan within 28 days prior to registration (or within 14 days prior to registration if the patient has received anthracycline in the 28 day window)
  • Zubrod performance status 0-2
  • Serum creatinine ≤ 2.0 times upper limit of normal (ULN)
  • Total bilirubin ≤ 2.0 times ULN (unless elevation is primarily due to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis AND not due to liver dysfunction)
  • AST and ALT ≤ 3.0 times ULN
  • Not pregnant or nursing and negative pregnancy test within 14 days prior to registration. Females of child-bearing potential must agree to use effective contraception
  • No HIV positivity unless the following criteria are met:

    • No history of AIDS-defining events
    • CD4 count ≥ 500/mm³
    • Viral load < 25,000 copies (< 50 copies if on combination antiretroviral therapy)
    • Not receiving zidovudine or stavudine as part of combination antiretroviral therapy
  • No uncontrolled systemic fungal, bacterial, viral, or other infection, defined as exhibiting ongoing signs/symptoms related to the infection with no improvement despite appropriate antibiotics or other treatment
  • Patients with prior malignancy (other than AML and MDS/CMML) eligible provided patient is in remission from that malignancy at least 6 months prior to registration. Except for AML and MDS treatment, all treatment related toxicities must have been resolved.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840177

Contacts
Contact: Sandi Hita 2106148808 ext 1028 sjhita@swog.org
Contact: Dana Sparks, MAT 2106148808 ext 1004 dsparks@swog.org

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Cancer Center Recruiting
Birmingham, Alabama, United States, 35233
Contact: Harry P. Erba    205-934-0309      
Principal Investigator: Harry P. Erba         
United States, Arkansas
University of Arkansas for Medical Sciences Active, not recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Stanford Cancer Institute Recruiting
Palo Alto, California, United States, 94304
Contact: Bruno C. de Medeiros    650-498-7061    ccto-office@stanford.edu   
Principal Investigator: Bruno C. de Medeiros         
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion Suspended
Aurora, Colorado, United States, 80045
Saint Mary's Hospital and Regional Medical Center Withdrawn
Grand Junction, Colorado, United States, 81502
United States, Connecticut
Smilow Cancer Hospital Care Center at Saint Francis Active, not recruiting
Hartford, Connecticut, United States, 06105
United States, Florida
Moffitt Cancer Center Suspended
Tampa, Florida, United States, 33612
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise Recruiting
Boise, Idaho, United States, 83706
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Saint Alphonsus Cancer Care Center-Caldwell Recruiting
Caldwell, Idaho, United States, 83605
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Kootenai Medical Center Recruiting
Coeur d'Alene, Idaho, United States, 83814
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Walter Knox Memorial Hospital Recruiting
Emmett, Idaho, United States, 83617
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Idaho Urologic Institute-Meridian Recruiting
Meridian, Idaho, United States, 83642
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Saint Alphonsus Medical Center-Nampa Recruiting
Nampa, Idaho, United States, 83686
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Kootenai Cancer Center Recruiting
Post Falls, Idaho, United States, 83854
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Kootenai Cancer Clinic Recruiting
Sandpoint, Idaho, United States, 83864
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
United States, Illinois
Saint Joseph Medical Center Suspended
Bloomington, Illinois, United States, 61701
Illinois CancerCare-Bloomington Recruiting
Bloomington, Illinois, United States, 61704
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Illinois CancerCare-Canton Recruiting
Canton, Illinois, United States, 61520
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Memorial Hospital of Carbondale Recruiting
Carbondale, Illinois, United States, 62902
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
SIH Cancer Institute Recruiting
Carterville, Illinois, United States, 62918
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Illinois CancerCare-Carthage Recruiting
Carthage, Illinois, United States, 62321
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Centralia Oncology Clinic Recruiting
Centralia, Illinois, United States, 62801
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Cancer Care Center of Decatur Recruiting
Decatur, Illinois, United States, 62526
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Crossroads Cancer Center Recruiting
Effingham, Illinois, United States, 62401
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Illinois CancerCare-Eureka Recruiting
Eureka, Illinois, United States, 61530
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Illinois CancerCare-Galesburg Recruiting
Galesburg, Illinois, United States, 61401
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Western Illinois Cancer Treatment Center Recruiting
Galesburg, Illinois, United States, 61401
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Illinois CancerCare-Kewanee Clinic Recruiting
Kewanee, Illinois, United States, 61443
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Illinois CancerCare-Macomb Recruiting
Macomb, Illinois, United States, 61455
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Ellen R. Gaynor    708-226-4357      
Principal Investigator: Ellen R. Gaynor         
Illinois CancerCare-Ottawa Clinic Recruiting
Ottawa, Illinois, United States, 61350
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Radiation Oncology of Northern Illinois Suspended
Ottawa, Illinois, United States, 61350
Illinois CancerCare-Pekin Recruiting
Pekin, Illinois, United States, 61554
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Recruiting
Pekin, Illinois, United States, 61554
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Methodist Medical Center of Illinois Recruiting
Peoria, Illinois, United States, 61603
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Illinois CancerCare-Peoria Recruiting
Peoria, Illinois, United States, 61615
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
OSF Saint Francis Radiation Oncology at Peoria Cancer Center Recruiting
Peoria, Illinois, United States, 61615
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
OSF Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Illinois CancerCare-Peru Recruiting
Peru, Illinois, United States, 61354
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Valley Radiation Oncology Recruiting
Peru, Illinois, United States, 61354
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Illinois CancerCare-Princeton Recruiting
Princeton, Illinois, United States, 61356
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Central Illinois Hematology Oncology Center Recruiting
Springfield, Illinois, United States, 62702
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62702
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Springfield Clinic Recruiting
Springfield, Illinois, United States, 62702
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Cancer Care Specialists of Illinois-Swansea Recruiting
Swansea, Illinois, United States, 62226
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Memorial and Saint Elizabeth's Health Care Services LLP Recruiting
Swansea, Illinois, United States, 62226
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
United States, Kansas
Hospital District Sixth of Harper County Suspended
Anthony, Kansas, United States, 67003
Cancer Center of Kansas - Chanute Recruiting
Chanute, Kansas, United States, 66720
Contact: Shaker R. Dakhil    316-268-5374      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Dodge City Recruiting
Dodge City, Kansas, United States, 67801
Contact: Shaker R. Dakhil    316-268-5374      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - El Dorado Recruiting
El Dorado, Kansas, United States, 67042
Contact: Shaker R. Dakhil    316-268-5374      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Fort Scott Recruiting
Fort Scott, Kansas, United States, 66701
Contact: Shaker R. Dakhil    316-268-5374      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Independence Recruiting
Independence, Kansas, United States, 67301
Contact: Shaker R. Dakhil    316-268-5374      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Kingman Recruiting
Kingman, Kansas, United States, 67068
Contact: Shaker R. Dakhil    316-268-5374      
Principal Investigator: Shaker R. Dakhil         
Lawrence Memorial Hospital Recruiting
Lawrence, Kansas, United States, 66044
Contact: Shaker R. Dakhil    316-268-5374      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Liberal Recruiting
Liberal, Kansas, United States, 67905
Contact: Shaker R. Dakhil    316-268-5374      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Manhattan Recruiting
Manhattan, Kansas, United States, 66502
Contact: Shaker R. Dakhil    316-268-5374      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - McPherson Recruiting
McPherson, Kansas, United States, 67460
Contact: Shaker R. Dakhil    316-268-5374      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Newton Recruiting
Newton, Kansas, United States, 67114
Contact: Shaker R. Dakhil    316-268-5374      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Parsons Recruiting
Parsons, Kansas, United States, 67357
Contact: Shaker R. Dakhil    316-268-5374      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Pratt Recruiting
Pratt, Kansas, United States, 67124
Contact: Shaker R. Dakhil    316-268-5374      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Salina Recruiting
Salina, Kansas, United States, 67401
Contact: Shaker R. Dakhil    316-268-5374      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Wellington Recruiting
Wellington, Kansas, United States, 67152
Contact: Shaker R. Dakhil    316-268-5374      
Principal Investigator: Shaker R. Dakhil         
Associates In Womens Health Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil    316-268-5374      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Wichita Medical Arts Tower Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil    316-268-5374      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil    316-268-5374      
Principal Investigator: Shaker R. Dakhil         
Via Christi Regional Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil    316-268-5374      
Principal Investigator: Shaker R. Dakhil         
Wesley Medical Center Suspended
Wichita, Kansas, United States, 67214
Wichita NCI Community Oncology Research Program Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil    316-268-5374      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Winfield Recruiting
Winfield, Kansas, United States, 67156
Contact: Shaker R. Dakhil    316-268-5374      
Principal Investigator: Shaker R. Dakhil         
United States, Louisiana
Hematology/Oncology Clinic LLP Active, not recruiting
Baton Rouge, Louisiana, United States, 70809
Tulane University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Hana F. Safah    504-988-6121      
Principal Investigator: Hana F. Safah         
Louisiana State University Health Sciences Center Shreveport Suspended
Shreveport, Louisiana, United States, 71103
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Michigan Cancer Research Consortium NCORP Terminated
Ann Arbor, Michigan, United States, 48106
IHA Hematology Oncology Consultants-Brighton Recruiting
Brighton, Michigan, United States, 48114
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Saint Joseph Mercy Brighton Recruiting
Brighton, Michigan, United States, 48114
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
IHA Hematology Oncology Consultants-Canton Recruiting
Canton, Michigan, United States, 48188
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Saint Joseph Mercy Canton Health Center Recruiting
Canton, Michigan, United States, 48188
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Caro Cancer Center Recruiting
Caro, Michigan, United States, 48723
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
IHA Hematology Oncology Consultants-Chelsea Recruiting
Chelsea, Michigan, United States, 48118
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Saint Joseph Mercy Chelsea Recruiting
Chelsea, Michigan, United States, 48118
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Hematology Oncology Consultants-Clarkston Recruiting
Clarkston, Michigan, United States, 48346
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Newland Medical Associates-Clarkston Recruiting
Clarkston, Michigan, United States, 48346
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Beaumont Hospital-Dearborn Recruiting
Dearborn, Michigan, United States, 48124
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Saint John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Great Lakes Cancer Management Specialists-Doctors Park Recruiting
East China Township, Michigan, United States, 48054
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48502
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Genesee Cancer and Blood Disease Treatment Center Recruiting
Flint, Michigan, United States, 48503
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Genesee Hematology Oncology PC Recruiting
Flint, Michigan, United States, 48503
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Genesys Hurley Cancer Institute Recruiting
Flint, Michigan, United States, 48503
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Genesys Regional Medical Center-West Flint Campus Withdrawn
Flint, Michigan, United States, 48532
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Recruiting
Grosse Pointe Woods, Michigan, United States, 48236
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Lymphoma Clinic of Michigan Recruiting
Grosse Pointe Woods, Michigan, United States, 48236
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Michigan Breast Specialists-Grosse Pointe Woods Recruiting
Grosse Pointe Woods, Michigan, United States, 48236
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Allegiance Health Recruiting
Jackson, Michigan, United States, 49201
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Sparrow Hospital Recruiting
Lansing, Michigan, United States, 48912
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Hope Cancer Clinic Recruiting
Livonia, Michigan, United States, 48154
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Saint Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Hematology Oncology Associates East PC Recruiting
Macomb, Michigan, United States, 48044
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Michigan Breast Specialists-Macomb Township Recruiting
Macomb, Michigan, United States, 48044
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
21st Century Oncology-Pontiac Recruiting
Pontiac, Michigan, United States, 48341
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Hope Cancer Center Recruiting
Pontiac, Michigan, United States, 48341
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Newland Medical Associates-Pontiac Recruiting
Pontiac, Michigan, United States, 48341
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Saint Joseph Mercy Oakland Recruiting
Pontiac, Michigan, United States, 48341
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Lake Huron Medical Center Suspended
Port Huron, Michigan, United States, 48060
Great Lakes Cancer Management Specialists-Rochester Hills Recruiting
Rochester Hills, Michigan, United States, 48309
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Saint Mary's of Michigan Recruiting
Saginaw, Michigan, United States, 48601
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Oncology Hematology Associates of Saginaw Valley PC Recruiting
Saginaw, Michigan, United States, 48604
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Bhadresh Nayak MD PC-Sterling Heights Recruiting
Sterling Heights, Michigan, United States, 48312
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Great Lakes Cancer Management Specialists-Macomb Professional Building Recruiting
Warren, Michigan, United States, 48093
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Macomb Hematology Oncology PC Recruiting
Warren, Michigan, United States, 48093
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Michigan Breast Specialists-Warren Recruiting
Warren, Michigan, United States, 48093
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Saint John Macomb-Oakland Hospital Recruiting
Warren, Michigan, United States, 48093
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Saint Mary's Oncology/Hematology Associates of West Branch Recruiting
West Branch, Michigan, United States, 48661
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Huron Gastroenterology PC Recruiting
Ypsilanti, Michigan, United States, 48106
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
IHA Hematology Oncology Consultants-Ann Arbor Recruiting
Ypsilanti, Michigan, United States, 48197
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Stephanie L. Elkins    601-815-6700      
Principal Investigator: Stephanie L. Elkins         
United States, Missouri
Parkland Health Center-Bonne Terre Recruiting
Bonne Terre, Missouri, United States, 63628
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Saint Francis Medical Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Southeast Cancer Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Capital Region Medical Center-Goldschmidt Cancer Center Recruiting
Jefferson City, Missouri, United States, 65109
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Missouri Baptist Medical Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Sainte Genevieve County Memorial Hospital Recruiting
Sainte Genevieve, Missouri, United States, 63670
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Missouri Baptist Sullivan Hospital Recruiting
Sullivan, Missouri, United States, 63080
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Missouri Baptist Outpatient Center-Sunset Hills Recruiting
Sunset Hills, Missouri, United States, 63127
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
United States, Montana
Community Hospital of Anaconda Recruiting
Anaconda, Montana, United States, 59711
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Billings Clinic Cancer Center Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Saint Vincent Healthcare Suspended
Billings, Montana, United States, 59101
Frontier Cancer Center and Blood Institute-Billings Terminated
Billings, Montana, United States, 59102
Montana Cancer Consortium NCORP Recruiting
Billings, Montana, United States, 59102
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Bozeman Deaconess Hospital Recruiting
Bozeman, Montana, United States, 59715
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Saint James Community Hospital and Cancer Treatment Center Suspended
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Great Falls Clinic Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Saint Peter's Community Hospital Suspended
Helena, Montana, United States, 59601
Glacier Oncology PLLC Terminated
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Montana Cancer Specialists Terminated
Missoula, Montana, United States, 59802
Saint Patrick Hospital - Community Hospital Suspended
Missoula, Montana, United States, 59802
Community Medical Hospital Recruiting
Missoula, Montana, United States, 59804
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
United States, Nevada
University Medical Center of Southern Nevada Withdrawn
Las Vegas, Nevada, United States, 89102
Nevada Cancer Research Foundation CCOP Withdrawn
Las Vegas, Nevada, United States, 89106
Sunrise Hospital and Medical Center Withdrawn
Las Vegas, Nevada, United States, 89109
United States, New Mexico
University of New Mexico Cancer Center Suspended
Albuquerque, New Mexico, United States, 87102
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Paul M. Barr    585-275-5830      
Principal Investigator: Paul M. Barr         
United States, North Carolina
Southeastern Medical Oncology Center-Clinton Recruiting
Clinton, North Carolina, United States, 28328
Contact: James N. Atkins    919-580-0000      
Principal Investigator: James N. Atkins         
Southeastern Medical Oncology Center-Goldsboro Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins    919-580-0000      
Principal Investigator: James N. Atkins         
Wayne Memorial Hospital Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins    919-580-0000      
Principal Investigator: James N. Atkins         
Southeastern Medical Oncology Center-Jacksonville Recruiting
Jacksonville, North Carolina, United States, 28546
Contact: James N. Atkins    919-580-0000      
Principal Investigator: James N. Atkins         
Southeastern Medical Oncology Center-Wilson Recruiting
Wilson, North Carolina, United States, 27893
Contact: James N. Atkins    919-580-0000      
Principal Investigator: James N. Atkins         
Southeast Clinical Oncology Research (SCOR) Consortium NCORP Recruiting
Winston-Salem, North Carolina, United States, 27104
Contact: James D. Bearden    800-486-5941      
Principal Investigator: James D. Bearden         
United States, Ohio
Akron General Medical Center Withdrawn
Akron, Ohio, United States, 44307
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Aaron T. Gerds    866-223-8100      
Principal Investigator: Aaron T. Gerds         
United States, Oregon
Saint Alphonsus Medical Center-Baker City Recruiting
Baker City, Oregon, United States, 97814
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Saint Alphonsus Medical Center-Ontario Recruiting
Ontario, Oregon, United States, 97914
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Rachel J. Cook    503-494-1080    trials@ohsu.edu   
Principal Investigator: Rachel J. Cook         
United States, Pennsylvania
Lehigh Valley Hospital-Cedar Crest Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
Lehigh Valley Hospital - Muhlenberg Recruiting
Bethlehem, Pennsylvania, United States, 18017
Contact: Philip J. Stella    734-712-4673      
Principal Investigator: Philip J. Stella         
United States, South Carolina
AnMed Health Hospital Withdrawn
Anderson, South Carolina, United States, 29621
Spartanburg Medical Center Withdrawn
Spartanburg, South Carolina, United States, 29303
United States, Texas
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Martha P. Mims    713-798-1354    burton@bcm.edu   
Principal Investigator: Martha P. Mims         
Baylor Saint Luke's Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Martha P. Mims    713-798-1354    burton@bcm.edu   
Principal Investigator: Martha P. Mims         
Ben Taub General Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Martha P. Mims    713-798-1354    burton@bcm.edu   
Principal Investigator: Martha P. Mims         
Michael E DeBakey VA Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Martha P. Mims    713-798-1354    burton@bcm.edu   
Principal Investigator: Martha P. Mims         
United States, Washington
Cancer Care Center at Island Hospital Suspended
Anacortes, Washington, United States, 98221
PeaceHealth Saint Joseph Medical Center Suspended
Bellingham, Washington, United States, 98225
Harrison HealthPartners Hematology and Oncology-Bremerton Suspended
Bremerton, Washington, United States, 98310
Highline Medical Center-Main Campus Suspended
Burien, Washington, United States, 98166
Swedish Medical Center-Edmonds Suspended
Edmonds, Washington, United States, 98026
Swedish Cancer Institute-Issaquah Suspended
Issaquah, Washington, United States, 98029
Kadlec Clinic Hematology and Oncology Suspended
Kennewick, Washington, United States, 99336
Seattle Cancer Care Alliance at EvergreenHealth Suspended
Kirkland, Washington, United States, 98034
Skagit Valley Hospital Suspended
Mount Vernon, Washington, United States, 98274
Harrison HealthPartners Hematology and Oncology-Poulsbo Suspended
Poulsbo, Washington, United States, 98370
Harborview Medical Center Suspended
Seattle, Washington, United States, 98104
Minor and James Medical PLLC Suspended
Seattle, Washington, United States, 98104
Swedish Medical Center-Ballard Campus Suspended
Seattle, Washington, United States, 98107
Fred Hutchinson Cancer Research Center Suspended
Seattle, Washington, United States, 98109
Group Health Cooperative-Seattle Suspended
Seattle, Washington, United States, 98112
Swedish Medical Center-First Hill Suspended
Seattle, Washington, United States, 98122-4307
University of Washington Medical Center Suspended
Seattle, Washington, United States, 98195
United General Hospital Suspended
Sedro-Woolley, Washington, United States, 98284
Cancer Care Northwest - Spokane South Suspended
Spokane, Washington, United States, 99202
Evergreen Hematology and Oncology PS Suspended
Spokane, Washington, United States, 99218
Rockwood Clinic Suspended
Spokane, Washington, United States, 99220
Wenatchee Valley Hospital and Clinics Suspended
Wenatchee, Washington, United States, 98801
United States, Wisconsin
Froedtert and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Laura C. Michaelis    414-805-4380      
Principal Investigator: Laura C. Michaelis         
United States, Wyoming
Rocky Mountain Oncology Terminated
Casper, Wyoming, United States, 82609
Big Horn Basin Cancer Center Suspended
Cody, Wyoming, United States, 82414
Billings Clinic-Cody Recruiting
Cody, Wyoming, United States, 82414
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Welch Cancer Center Recruiting
Sheridan, Wyoming, United States, 82801
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Anjali Advani, MD The Cleveland Clinic
  More Information

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00840177     History of Changes
Other Study ID Numbers: S0919
S0919 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
NCI-2009-01183 ( Other Identifier: NCI )
Study First Received: February 7, 2009
Last Updated: July 12, 2017

Keywords provided by Southwest Oncology Group:
recurrent adult acute myeloid leukemia
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Pravastatin
Idarubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

ClinicalTrials.gov processed this record on August 18, 2017