S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia
Conditions
Leukemia
Conditions: official terms
Leukemia - Leukemia, Myeloid, Acute
Conditions: Keywords
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)
Study Type
Interventional
Study Phase
Phase 2
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: cytarabine Type: Drug
Name: idarubicin Type: Drug
Name: pravastatin sodium Type: Drug
Overall Status
Recruiting
Summary
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Status: Recruiting
Contact: Clinical Trial Office - Arkansas Cancer Research Center at Uni - 501-686-8274
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States
Status: Recruiting
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
Grand Junction, Colorado, United States
Status: Recruiting
Contact: Daniel A. Pollyea - 970-244-7500
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States
Status: Recruiting
Contact: Philip J. Stella, MD - 734-712-1000
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
Status: Recruiting
Contact: Clinical Trials Office - Saint Alphonsus Cancer Care Center - 208-367-7954
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States
Status: Recruiting
Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care - 217-876-4750
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States
Status: Recruiting
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center - 708-226-4357
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States
Status: Recruiting
Contact: Clinical Trials Office - Regional Cancer Center at Memorial Me - 217-788-4233
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas-Independence
Independence, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
CCOP - Wichita
Wichita, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Wesley Medical Center
Wichita, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, United States
Status: Recruiting
Contact: Clinical Trials Office - Tulane Cancer Center - 504-988-6121
Hematology-Oncology Clinic
Baton Rouge, Louisiana, United States
Status: Recruiting
Contact: Hana F. Safah - 225-767-0822
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Philip J. Stella, MD - 734-712-1000
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Philip J. Stella, MD - 734-712-1000
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Status: Recruiting
Contact: Clinical Trials Office - Oakwood Cancer Center at Oakwood Hosp - 313-593-8090
Hurley Medical Center
Flint, Michigan, United States
Status: Recruiting
Contact: Clinical Trials Office - Hurley Medical Center - 810-762-8057
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
Status: Recruiting
Contact: Clincial Trials Office - Van Elslander Cancer Center at St. Jo - 313-343-3166
Foote Memorial Hospital
Jackson, Michigan, United States
Status: Recruiting
Contact: Philip J. Stella, MD - 734-712-1000
Sparrow Regional Cancer Center
Lansing, Michigan, United States
Status: Recruiting
Contact: Clinical Trials Office - Sparrow Regional Cancer Center - 517-364-2890
St. Mary Mercy Hospital
Livonia, Michigan, United States
Status: Recruiting
Contact: Philip J. Stella, MD - 734-712-1000
St. Joseph Mercy Oakland
Pontiac, Michigan, United States
Status: Recruiting
Contact: Philip J. Stella, MD - 734-712-1000
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States
Status: Recruiting
Contact: Philip J. Stella, MD - 734-712-1000
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States
Status: Recruiting
Contact: Clinical Trials Office - Seton Cancer Institute - Saginaw - 989-776-8411
St. John Macomb Hospital
Warren, Michigan, United States
Status: Recruiting
Contact: Philip J. Stella, MD - 734-712-1000
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States
Status: Recruiting
Contact: Stephanie L. Elkins - 601-984-5590
Billings Clinic - Downtown
Billings, Montana, United States
Status: Recruiting
Contact: Clinical Trials Office - Billings Clinic - Downtown - 800-996-2663 - research@billingsclinic.org
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Status: Recruiting
Contact: Benjamin T. Marchello, MD - 406-238-6290
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States
Status: Recruiting
Contact: Benjamin T. Marchello, MD - 406-238-6290
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States
Status: Recruiting
Contact: Benjamin T. Marchello, MD - 406-238-6290
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States
Status: Recruiting
Contact: Benjamin T. Marchello, MD - 406-238-6290
Great Falls Clinic - Main Facility
Great Falls, Montana, United States
Status: Recruiting
Contact: Benjamin T. Marchello, MD - 406-238-6290
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States
Status: Recruiting
Contact: Benjamin T. Marchello, MD - 406-238-6290
St. Peter's Hospital
Helena, Montana, United States
Status: Recruiting
Contact: Benjamin T. Marchello, MD - 406-238-6290
Glacier Oncology, PLLC
Kalispell, Montana, United States
Status: Recruiting
Contact: Benjamin T. Marchello, MD - 406-238-6290
Kalispell Regional Medical Center
Kalispell, Montana, United States
Status: Recruiting
Contact: Benjamin T. Marchello, MD - 406-238-6290
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States
Status: Recruiting
Contact: Clinical Trials Office - Montana Cancer Center at St. Patrick - 406-329-7029
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States
Status: Recruiting
Contact: Clinical Trials Office - Montana Cancer Specialists at Montana - 406-238-6962
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton, MD, CM - 702-384-0013
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton, MD, CM - 702-384-0013
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton, MD, CM - 702-384-0013
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Status: Recruiting
Contact: Clinical Trials Office - University of New Mexico Cancer Cente - 505-272-6972
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Status: Recruiting
Contact: Jonathan W. Friedberg - 585-275-5345
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Status: Recruiting
Contact: James N. Atkins, MD - 919-580-0000
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Status: Recruiting
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente - 866-223-8100
Baylor University Medical Center - Houston
Houston, Texas, United States
Status: Recruiting
Contact: Martha P. Mims - 713-798-8070
Ben Taub General Hospital
Houston, Texas, United States
Status: Recruiting
Contact: Martha P. Mims - 713-873-2000
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
Houston, Texas, United States
Status: Recruiting
Contact: Martha P. Mims - 832-355-3490
Veterans Affairs Medical Center - Houston
Houston, Texas, United States
Status: Recruiting
Contact: Martha P. Mims - 713-794-7111
Island Hospital Cancer Care Center at Island Hospital
Anacortes, Washington, United States
Status: Recruiting
Contact: Saul E. Rivkin, MD - 206-386-2441
St. Joseph Cancer Center
Bellingham, Washington, United States
Status: Recruiting
Contact: Saul E. Rivkin, MD - 206-386-2441
Olympic Hematology and Oncology
Bremerton, Washington, United States
Status: Recruiting
Contact: Saul E. Rivkin, MD - 206-386-2441
Highline Medical Center Cancer Center
Burien, Washington, United States
Status: Recruiting
Contact: Saul E. Rivkin, MD - 206-386-2441
Swedish Medical Center - Issaquah Campus
Issaquah, Washington, United States
Status: Recruiting
Contact: Saul E. Rivkin, MD - 206-386-2441
Columbia Basin Hematology
Kennewick, Washington, United States
Status: Recruiting
Contact: Saul E. Rivkin, MD - 206-386-2441
Skagit Valley Hospital Cancer Care Center
Mount Vernon, Washington, United States
Status: Recruiting
Contact: Saul E. Rivkin, MD - 206-386-2441
Harrison Poulsbo Hematology and Onocology
Poulsbo, Washington, United States
Status: Recruiting
Contact: Saul E. Rivkin, MD - 206-386-2441
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Status: Recruiting
Contact: Saul E. Rivkin, MD - 206-386-2441
Group Health Central Hospital
Seattle, Washington, United States
Status: Recruiting
Contact: Clinical Trials Office - Group Health Central Hospital - 206-287-2900
Harborview Medical Center
Seattle, Washington, United States
Status: Recruiting
Contact: Saul E. Rivkin, MD - 206-386-2441
Minor and James Medical, PLLC
Seattle, Washington, United States
Status: Recruiting
Contact: Saul E. Rivkin, MD - 206-386-2441
Polyclinic First Hill
Seattle, Washington, United States
Status: Recruiting
Contact: Saul E. Rivkin, MD - 206-386-2441
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States
Status: Recruiting
Contact: Saul E. Rivkin, MD - 206-386-2441
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States
Status: Recruiting
Contact: Saul E. Rivkin, MD - 206-386-2441
North Puget Oncology at United General Hospital
Sedro-Woolley, Washington, United States
Status: Recruiting
Contact: Saul E. Rivkin, MD - 206-386-2441
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Status: Recruiting
Contact: Clinical Trials Office - Cancer Care Northwest - Spokane South - 509-228-1083
Evergreen Hematology and Oncology, PS
Spokane, Washington, United States
Status: Recruiting
Contact: Saul E. Rivkin, MD - 206-386-2441
Wenatchee Valley Medical Center
Wenatchee, Washington, United States
Status: Recruiting
Contact: Clinical Trials Office - Wenatchee Valley Medical Center - 509-665-5800
Rocky Mountain Oncology
Casper, Wyoming, United States
Status: Recruiting
Contact: Benjamin T. Marchello, MD - 406-238-6290
Start Date
August 2009
Completion Date
February 2018
Sponsors
Southwest Oncology Group
Source
Southwest Oncology Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page