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



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology, Leukemia
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:August 2009
End Date:July 2019

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

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.

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.

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.
We found this trial at
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3015 North Ballas Road
Saint Louis, Missouri 63131
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Missouri Baptist Medical Center You just feel it. The smile that greets you. The hand...
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1201 Camino de Salud Northeast
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2545 Schoenersville Rd
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1 Hurley Plaza
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2500 N State St
Jackson, Mississippi 39216
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529 West Markham Street
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
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1100 Fairview Avenue North
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601 South Sherman Street
Spokane, Washington 99202
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Allentown, Pennsylvania 18103
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
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13001 E. 17th Pl.
Aurora, Colorado 80045
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Baker City, Oregon 97814
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Bonne Terre, Missouri 63628
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915 Highland Blvd
Bozeman, Montana 59715
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3123 Medical Dr
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210 W Walnut St
Canton, Illinois 61520
309-647-5240
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1600 South Canton Center Road
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211 Saint Francis Drive
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789 Mt Auburn Rd
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Carbondale, Illinois 62902
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401 North Hooper Street
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160 S Adams St
Carthage, Illinois 62321
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6501 E 2nd St
Casper, Wyoming 82609
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505 S Plummer Ave
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14650 East Old US Highway 12
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775 South Main Street
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5680 Bow Pointe Drive
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31500 Telegraph Road
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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2300 N Edward St
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22101 Moross Rd
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2020 Central Ave
Dodge City, Kansas 67801
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East China Township, Michigan 48054
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700 West Central
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101 S Major St
Eureka, Illinois 61530
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302 Kensington Avenue
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302 Kensington Ave
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Galesburg, Illinois 61401
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3315 N Seminary St
Galesburg, Illinois 61401
309-344-9269
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2700 Wayne Memorial Dr
Goldsboro, North Carolina 27534
(919) 736-1110
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1117 29th St S
Great Falls, Montana 59405
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1400 29th Street South
Great Falls, Montana 59405
406-454-2171
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19229 Mack Avenue
Grosse Pointe Woods, Michigan 48236
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19229 Mack Ave # 34
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1504 Taub Loop
Houston, Texas 77030
(713) 873-2000
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Ben Taub General Hospital Located in the heart of the Texas Medical Center, Ben Taub...
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Houston, Texas 77030
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Houston, Texas 77030
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2002 Holcombe Blvd
Houston, Texas 77030
(713) 791-1414
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800 W. Laurel
Independence, Kansas 67301
620-331-4099
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Issaquah, Washington 98029
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205 NE Ave
Jackson, Michigan 49201
(517) 788-4800
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Jacksonville, North Carolina 28546
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1432 Southwest Blvd.
Jefferson City, Missouri 65109
(573) 632-4800
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75 Claremont St Ste E
Kalispell, Montana 59901
(406) 752-7600
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310 Sunnyview Ln
Kalispell, Montana 59901
(406) 752-5111
Principal Investigator: Benjamin T. Marchello
Phone: 800-648-6274
Kalispell Regional Medical Center Nestled in the beautiful Flathead Valley of Northwestern Montana, Kalispell Regional...
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Kennewick, Washington 99336
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205 Tenney St
Kewanee, Illinois 61443
309-852-0596
Principal Investigator: James L. Wade
Phone: 217-876-4740
Illinois CancerCare - Kewanee Clinic Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer...
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750 Avenue D West
Kingman, Kansas 67068
(620) 532-3147
Principal Investigator: Shaker R. Dakhil
Phone: 316-268-5374
Cancer Center of Kansas, PA - Kingman Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Kingman, KS
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Kirkland, WA
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1215 E Michigan Ave
Lansing, Michigan 48912
(517) 364-1000
Principal Investigator: Philip J. Stella
Phone: 734-712-4673
Sparrow Hospital Sparrow has grown to become the region's largest health system, and its diverse...
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Lansing, MI
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325 Maine Street
Lawrence, Kansas 66044
(785) 505-5000
Principal Investigator: Shaker R. Dakhil
Phone: 316-268-5374
Lawrence Memorial Hospital Lawrence Memorial Hospital (LMH), in collaboration with its medical staff, is dedicated...
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315 W. 15th St.
Liberal, Kansas 67905
(620) 629-6727
Principal Investigator: Shaker R. Dakhil
Phone: 316-268-5374
Cancer Center of Kansas, PA - Liberal Dr. H.E. Hynes founded Cancer Center of Kansas,...
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