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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 April 2014 by Southwest Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00840177
First received: February 7, 2009
Last updated: April 4, 2014
Last verified: April 2014
  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: 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 ] [ Designated as safety issue: No ]
  • Relapse-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE version 4.0 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Correlation between pre-study cytogenetic features and response [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: August 2009
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: June 2017 (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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Morphologically confirmed diagnosis of acute myeloid leukemia (AML)
  • Must have received ≥ 1 prior chemotherapy regimen for AML

    • Any type of prior chemotherapy allowed
    • Must have achieved a complete remission (CR) (including CR with incomplete recovery) that lasted ≥ 3 months after the last induction regimen and then subsequently relapsed

      • Relapse must be documented by a bone marrow examination demonstrating > 5% blasts in the bone marrow not attributable to another cause
  • No acute promyelocytic leukemia (i.e., APL, FAB M3) or blastic transformation of chronic myelogenous leukemia
  • No clinical evidence of leptomeningeal disease
  • Concurrent registration on research study SWOG-9007 required

PATIENT CHARACTERISTICS:

  • 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
  • Ejection fraction ≥ 45% by echocardiogram or MUGA scan
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No symptomatic congestive heart failure, coronary artery disease, cardiomyopathy, or uncontrolled arrhythmias
  • 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
  • Other prior malignancy allowed provided patient is in remission from that malignancy

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 6 months since prior chemotherapy or radiotherapy and recovered
  • No prior autologous or allogeneic stem cell transplantation
  • Prior or concurrent hydroxyurea to control high WBC counts allowed
  • No concurrent statin treatments
  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 J Fredette 2106148808 ext 1002 sfredette@swog.org
Contact: Dana Sparks, MAT 2106148808 ext 1004 dsparks@swog.org

  Hide Study Locations
Locations
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Clinical Trial Office - Arkansas Cancer Research Center at Uni    501-686-8274      
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Clinical Trials Office - University of Colorado Cancer Center    720-848-0650      
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Recruiting
Grand Junction, Colorado, United States, 81502
Contact: Daniel A. Pollyea    970-244-7500      
United States, Connecticut
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Recruiting
Hartford, Connecticut, United States, 06105
Contact: Philip J. Stella, MD    734-712-1000      
United States, Idaho
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83706
Contact: Clinical Trials Office - Saint Alphonsus Cancer Care Center    208-367-7954      
United States, Illinois
Decatur Memorial Hospital Cancer Care Institute Recruiting
Decatur, Illinois, United States, 62526
Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care    217-876-4750      
Cardinal Bernardin Cancer Center at Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center    708-226-4357      
Regional Cancer Center at Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781-0001
Contact: Clinical Trials Office - Regional Cancer Center at Memorial Me    217-788-4233      
United States, Kansas
Cancer Center of Kansas, PA - Chanute Recruiting
Chanute, Kansas, United States, 66720
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Dodge City Recruiting
Dodge City, Kansas, United States, 67801
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas - Fort Scott Recruiting
Fort Scott, Kansas, United States, 66701
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas-Independence Recruiting
Independence, Kansas, United States, 67301
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Kingman Recruiting
Kingman, Kansas, United States, 67068
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Lawrence Memorial Hospital Recruiting
Lawrence, Kansas, United States, 66044
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Liberal Recruiting
Liberal, Kansas, United States, 67901
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Newton Recruiting
Newton, Kansas, United States, 67114
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Parsons Recruiting
Parsons, Kansas, United States, 67357
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Pratt Recruiting
Pratt, Kansas, United States, 67124
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Salina Recruiting
Salina, Kansas, United States, 67401
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Wellington Recruiting
Wellington, Kansas, United States, 67152
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Associates in Womens Health, PA - North Review Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Medical Arts Tower Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
CCOP - Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Via Christi Cancer Center at Via Christi Regional Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Wesley Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Winfield Recruiting
Winfield, Kansas, United States, 67156
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
United States, Louisiana
Tulane Cancer Center Office of Clinical Research Recruiting
Alexandria, Louisiana, United States, 71315-3198
Contact: Clinical Trials Office - Tulane Cancer Center    504-988-6121      
Hematology-Oncology Clinic Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Hana F. Safah    225-767-0822      
United States, Michigan
CCOP - Michigan Cancer Research Consortium Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Philip J. Stella, MD    734-712-1000      
Saint Joseph Mercy Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Philip J. Stella, MD    734-712-1000      
Oakwood Cancer Center at Oakwood Hospital and Medical Center Recruiting
Dearborn, Michigan, United States, 48123-2500
Contact: Clinical Trials Office - Oakwood Cancer Center at Oakwood Hosp    313-593-8090      
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Hurley Medical Center    810-762-8057      
Van Elslander Cancer Center at St. John Hospital and Medical Center Recruiting
Grosse Pointe Woods, Michigan, United States, 48236
Contact: Clincial Trials Office - Van Elslander Cancer Center at St. Jo    313-343-3166      
Foote Memorial Hospital Recruiting
Jackson, Michigan, United States, 49201
Contact: Philip J. Stella, MD    734-712-1000      
Sparrow Regional Cancer Center Recruiting
Lansing, Michigan, United States, 48912-1811
Contact: Clinical Trials Office - Sparrow Regional Cancer Center    517-364-2890      
St. Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Philip J. Stella, MD    734-712-1000      
St. Joseph Mercy Oakland Recruiting
Pontiac, Michigan, United States, 48341-2985
Contact: Philip J. Stella, MD    734-712-1000      
Mercy Regional Cancer Center at Mercy Hospital Recruiting
Port Huron, Michigan, United States, 48060
Contact: Philip J. Stella, MD    734-712-1000      
Seton Cancer Institute at Saint Mary's - Saginaw Recruiting
Saginaw, Michigan, United States, 48601
Contact: Clinical Trials Office - Seton Cancer Institute - Saginaw    989-776-8411      
St. John Macomb Hospital Recruiting
Warren, Michigan, United States, 48093
Contact: Philip J. Stella, MD    734-712-1000      
United States, Mississippi
University of Mississippi Cancer Clinic Recruiting
Jackson, Mississippi, United States, 39216
Contact: Stephanie L. Elkins    601-984-5590      
United States, Montana
Billings Clinic - Downtown Recruiting
Billings, Montana, United States, 59107-7000
Contact: Clinical Trials Office - Billings Clinic - Downtown    800-996-2663    research@billingsclinic.org   
St. Vincent Healthcare Cancer Care Services Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD    406-238-6290      
Hematology-Oncology Centers of the Northern Rockies - Billings Recruiting
Billings, Montana, United States, 59102
Contact: Benjamin T. Marchello, MD    406-238-6290      
CCOP - Montana Cancer Consortium Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD    406-238-6290      
Bozeman Deaconess Cancer Center Recruiting
Bozeman, Montana, United States, 59715
Contact: Benjamin T. Marchello, MD    406-238-6290      
Great Falls Clinic - Main Facility Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello, MD    406-238-6290      
Sletten Cancer Institute at Benefis Healthcare Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello, MD    406-238-6290      
St. Peter's Hospital Recruiting
Helena, Montana, United States, 59601
Contact: Benjamin T. Marchello, MD    406-238-6290      
Glacier Oncology, PLLC Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD    406-238-6290      
Kalispell Regional Medical Center Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD    406-238-6290      
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Recruiting
Missoula, Montana, United States, 59807
Contact: Clinical Trials Office - Montana Cancer Center at St. Patrick    406-329-7029      
Montana Cancer Specialists at Montana Cancer Center Recruiting
Missoula, Montana, United States, 59807-7877
Contact: Clinical Trials Office - Montana Cancer Specialists at Montana    406-238-6962      
United States, Nevada
University Medical Center of Southern Nevada Recruiting
Las Vegas, Nevada, United States, 89102
Contact: John A. Ellerton, MD, CM    702-384-0013      
Sunrise Hospital and Medical Center Recruiting
Las Vegas, Nevada, United States, 89109
Contact: John A. Ellerton, MD, CM    702-384-0013      
CCOP - Nevada Cancer Research Foundation Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John A. Ellerton, MD, CM    702-384-0013      
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131-5636
Contact: Clinical Trials Office - University of New Mexico Cancer Cente    505-272-6972      
United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Jonathan W. Friedberg    585-275-5345      
United States, North Carolina
Wayne Memorial Hospital, Incorporated Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD    919-580-0000      
United States, Ohio
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente    866-223-8100      
United States, Texas
Baylor University Medical Center - Houston Recruiting
Houston, Texas, United States, 77030
Contact: Martha P. Mims    713-798-8070      
Ben Taub General Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Martha P. Mims    713-873-2000      
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Martha P. Mims    832-355-3490      
Veterans Affairs Medical Center - Houston Recruiting
Houston, Texas, United States, 77030
Contact: Martha P. Mims    713-794-7111      
United States, Washington
Island Hospital Cancer Care Center at Island Hospital Recruiting
Anacortes, Washington, United States, 98221
Contact: Saul E. Rivkin, MD    206-386-2441      
St. Joseph Cancer Center Recruiting
Bellingham, Washington, United States, 98225
Contact: Saul E. Rivkin, MD    206-386-2441      
Olympic Hematology and Oncology Recruiting
Bremerton, Washington, United States, 98310
Contact: Saul E. Rivkin, MD    206-386-2441      
Highline Medical Center Cancer Center Recruiting
Burien, Washington, United States, 98166
Contact: Saul E. Rivkin, MD    206-386-2441      
Swedish Medical Center - Issaquah Campus Recruiting
Issaquah, Washington, United States, 98029
Contact: Saul E. Rivkin, MD    206-386-2441      
Columbia Basin Hematology Recruiting
Kennewick, Washington, United States, 99336
Contact: Saul E. Rivkin, MD    206-386-2441      
Skagit Valley Hospital Cancer Care Center Recruiting
Mount Vernon, Washington, United States, 98274
Contact: Saul E. Rivkin, MD    206-386-2441      
Harrison Poulsbo Hematology and Onocology Recruiting
Poulsbo, Washington, United States, 98370
Contact: Saul E. Rivkin, MD    206-386-2441      
Minor and James Medical, PLLC Recruiting
Seattle, Washington, United States, 98104
Contact: Saul E. Rivkin, MD    206-386-2441      
Group Health Central Hospital Recruiting
Seattle, Washington, United States, 98112
Contact: Clinical Trials Office - Group Health Central Hospital    206-287-2900      
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Saul E. Rivkin, MD    206-386-2441      
University Cancer Center at University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Saul E. Rivkin, MD    206-386-2441      
Polyclinic First Hill Recruiting
Seattle, Washington, United States, 98122
Contact: Saul E. Rivkin, MD    206-386-2441      
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Contact: Saul E. Rivkin, MD    206-386-2441      
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Recruiting
Seattle, Washington, United States, 98122-4307
Contact: Saul E. Rivkin, MD    206-386-2441      
North Puget Oncology at United General Hospital Recruiting
Sedro-Woolley, Washington, United States, 98284
Contact: Saul E. Rivkin, MD    206-386-2441      
Cancer Care Northwest - Spokane South Recruiting
Spokane, Washington, United States, 99202
Contact: Clinical Trials Office - Cancer Care Northwest - Spokane South    509-228-1083      
Evergreen Hematology and Oncology, PS Recruiting
Spokane, Washington, United States, 99218
Contact: Saul E. Rivkin, MD    206-386-2441      
Wenatchee Valley Medical Center Recruiting
Wenatchee, Washington, United States, 98801-2028
Contact: Clinical Trials Office - Wenatchee Valley Medical Center    509-665-5800      
United States, Wyoming
Rocky Mountain Oncology Recruiting
Casper, Wyoming, United States, 82609
Contact: Benjamin T. Marchello, MD    406-238-6290      
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Anjali Advani, MD The Cleveland Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00840177     History of Changes
Other Study ID Numbers: CDR0000633749, S0919, U10CA032102
Study First Received: February 7, 2009
Last Updated: April 4, 2014
Health Authority: United States: Federal Government

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
Neoplasms by Histologic Type
Cytarabine
Idarubicin
Pravastatin
Anti-Infective Agents
Antibiotics, Antineoplastic
Anticholesteremic Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Immunologic Factors
Immunosuppressive Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 24, 2014