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S0919, A Phase II Study of Idarubicin and Ara-C in Combination With Pravastatin for Relapsed Acute Myelogenous Leukemia (AML)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Leukemia

Thank you

Trial Information

S0919, A Phase II Study of Idarubicin and Ara-C in Combination With Pravastatin for Relapsed Acute Myelogenous Leukemia (AML)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete remission (CR) rate (including CR with incomplete recovery)

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Anjali Advani, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000633749

NCT ID:

NCT00840177

Start Date:

August 2009

Completion Date:

November 2015

Related Keywords:

  • Leukemia
  • 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)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
CCOP - Wichita Wichita, Kansas  67214-3882
Hurley Medical Center Flint, Michigan  48503
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Grand Junction, Colorado  81502
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
CCOP - Montana Cancer Consortium Billings, Montana  59101
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Veterans Affairs Medical Center - Houston Houston, Texas  77030
Wesley Medical Center Wichita, Kansas  67214
Sunrise Hospital and Medical Center Las Vegas, Nevada  89109-2306
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Baylor University Medical Center - Houston Houston, Texas  77030-2399
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Olympic Hematology and Oncology Bremerton, Washington  98310
Skagit Valley Hospital Cancer Care Center Mt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
North Puget Oncology at United General Hospital Sedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Tulane Cancer Center Office of Clinical Research Alexandria, Louisiana  71315-3198
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
University Medical Center of Southern Nevada Las Vegas, Nevada  89102
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Boise, Idaho  83706
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Lawrence Memorial Hospital Lawrence, Kansas  66044
Cancer Center of Kansas, PA - Liberal Liberal, Kansas  67905
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
St. Joseph Cancer Center Bellingham, Washington  98225
Columbia Basin Hematology Kennewick, Washington  99336
Harrison Poulsbo Hematology and Onocology Poulsbo, Washington  98370
Evergreen Hematology and Oncology, PS Spokane, Washington  99218
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Rocky Mountain Oncology Casper, Wyoming  82609
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Ben Taub General Hospital Houston, Texas  77030
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Hematology-Oncology Clinic Baton Rouge, Louisiana  70808
University of Colorado Cancer Center at UC Health Sciences Center Aurora, Colorado  80045
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital Houston, Texas  77030
Island Hospital Cancer Care Center at Island Hospital Anacortes, Washington  98221
Highline Medical Center Cancer Center Burien, Washington  98166
Swedish Medical Center - Issaquah Campus Issaquah, Washington  98029