Bortezomib and Combination Chemotherapy in Treating Younger Patients With Recurrent, Refractory, or Secondary Acute Myeloid Leukemia



Status:Completed
Conditions:Blood Cancer, Hematology, Leukemia
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:1 - 21
Updated:5/24/2018
Start Date:April 2008
End Date:December 2012

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A Phase II Pilot Study of Bortezomib (PS-341, Velcade) Combined With Reinduction Chemotherapy in Children and Young Adults With Recurrent, Refractory or Secondary Acute Myeloid Leukemia

This phase II trial is studying the side effects and best dose of bortezomib and to see how
well it works when given together with combination chemotherapy in treating younger patients
with recurrent, refractory, or secondary acute myeloid leukemia (AML). Bortezomib may stop
the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used
in chemotherapy, such as idarubicin, cytarabine, and etoposide, work in different ways to
stop the growth of cancer cells, either by killing the cells or by stopping them from
dividing. Giving more than one drug (combination chemotherapy) together with bortezomib may
kill more cancer cells

PRIMARY OBJECTIVES:

I. To determine the toxicities and tolerability of bortezomib in combination with
standard-relapse AML therapy (idarubicin/cytarabine or etoposide/high-dose cytarabine) in
pediatric and young adult patients with relapsed or primary-refractory or secondary AML.

II. To estimate the complete response rate to the Arm A and Arm B regimens.

SECONDARY OBJECTIVES:

I. To determine whether bortezomib inhibits proteasome activity, NF-kB activity and induces
apoptosis pathway proteins in leukemia myeloblasts. II. To determine the feasibility of
measuring AML stem cells in relapsed and recovering bone marrow.

OUTLINE: This is a multicenter, dose-escalation study of bortezomib. Patients are stratified
according to anthracycline*-equivalent cumulative exposure (≤ 400 mg/m² vs > 400 mg/m²).
Patients are assigned to 1 of 2 groups.

GROUP I (efficacy phase, patients with ≤ 400 mg/m² anthracycline-equivalent cumulative
exposure - Closed as of 08/01/10): Patients receive idarubicin IV over 15 minutes on days
1-3, low-dose cytarabine IV continuously over days 1-7, and bortezomib IV on days 1, 4, and
8.

GROUP II (dose-finding phase (closed as of 10/10) and efficacy phase, patients with > 400
mg/m² anthracycline*-equivalent cumulative exposure): Patients receive etoposide IV over 1
hour on days 1-5, high-dose cytarabine IV over 1 hour twice daily on days 1-5, and bortezomib
IV on days 1, 4, and 8.

NOTE: * Anthracycline restriction no longer required for group 2 as of 10/02/10.

All patients receive intrathecal cytarabine prior to courses 1 and 2. In both arms, treatment
repeats every 28 days for up to 2 courses in the absence of disease progression or
unacceptable toxicity.

After completion of study therapy, patients are followed periodically for at least 5 years.

Inclusion Criteria:

- Diagnosis of acute myeloid leukemia (AML) according to WHO classification

- At least 5% blasts in the bone marrow

- With or without extramedullary disease

- To be eligible for the dose-finding phase (closed as of 10/10) :

- Relapsed patients must meet the following criteria:

- Must have had a prior diagnosis of AML, but may NOT have inv(16) or t(8;21)
cytogenetics

- May be in first or any subsequent relapse

- If in first relapse, remission duration must be less than one year

- Refractory patients must meet the following criteria:

- Must have had a prior diagnosis of AML

- May have received one or more attempt at remission induction

- Patients with treatment-related AML may be previously treated or untreated for
secondary AML

- To be eligible for the efficacy phase:

- Relapsed patients must meet the following criteria:

- Must have had a prior diagnosis of AML, with no restriction on prior
cytogenetics

- Must be in first relapse

- Must not have received prior reinduction therapy

- Refractory patients must meet the following criteria:

- Must have had a prior diagnosis of AML

- Must not have received more than one attempt at remission induction (which
may consist of up to two therapy courses)

- Patients with treatment-related AML must be previously untreated for secondary
AML

- No juvenile myelomonocytic leukemia or acute promyelocytic leukemia (APL; FAB M3)

- Patients with the following CNS status are eligible only in the absence of neurologic
symptoms suggestive of CNS leukemia, such as cranial nerve palsy:

- CNS 1, defined as absence of blasts in cerebral spinal fluid (CSF) on cytospin
preparation, regardless of the number of WBCs

- CNS 2, defined as presence of < 5/μL WBCs in CSF and cytospin positive for
blasts, or > 5/uL WBCs but negative by Steinherz/Bleyer algorithm:

- CNS 2a: < 10/μL RBCs; < 5/μL WBCs and cytospin positive for blasts

- CNS 2b: ≥ 10/μL RBCs; < 5/μL WBCs and cytospin positive for blasts

- CNS 2c: ≥ 10/μL RBCs; ≥ 5/μL WBCs and cytospin positive for blasts but
negative by Steinherz/Bleyer algorithm

- Patients with CNS3 disease (presence of ≥ 5/μL WBCs in CSF and cytospin positive for
blasts [in the absence of a traumatic lumbar puncture] and/or clinical signs of CNS
leukemia) are not eligible

- CNS toxicity ≤ grade 2

- Lansky (patients ≤ 16 years of age) or Karnofsky (patients > 16 years of age)
performance status (PS) 50-100%

- ECOG PS 0-2

- No Down syndrome

- No Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone
marrow failure syndrome

- No evidence of active graft-vs-host disease

- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum
creatinine based on age/gender as follows:

- 0.4 mg/dL for patients 1 month to < 6 months of age

- 0.5 mg/dL for patients 6 months to < 1 year of age

- 0.6 mg/dL for patients 1 to < 2 years of age

- 0.8 mg/dL for patients 2 to < 6 years of age

- 1 mg/dL for patients 6 to < 10 years of age

- 1.2 mg/dL for patients 10 to < 13 years of age

- 1.5 mg/dL (male) or 1.4 mg/dL (female) for patients 13 to < 16 years of age

- 1.7 mg/dL (male) or 1.4 mg/dL (female) for patients ≥ 16 years of age

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age

- ALT < 3.0 times ULN for age (unless elevation due to leukemia involvement)

- Shortening fraction ≥ 27% by ECHO OR LVEF ≥ 50% by gated radionuclide

- Normal respiratory rate and pulse oximetry > 94% on room air

- FEV_1 ≥ 80% of predicted

- FVC and DLCO > 50% (corrected for hemoglobin)

- Patients who are unable to perform pulmonary function tests (PFTs) (e.g., because
of young age) will be excluded provided they have a medical history of
significant prior pulmonary events or chronic pulmonary disease (e.g., pneumonia
requiring mechanical ventilation support, pulmonary GVHD, pneumonectomy, or
pulmonary toxin exposure)

- Children with histories of resolved bronchiolitis, resolved viral pneumonias and
well-controlled asthma are eligible, even if they are unable to perform PFTs

- Patients with seizure disorder may be enrolled if on a non-enzyme-inducing
anticonvulsant and if seizures are well-controlled

- No uncontrolled infection

- No known allergy to idarubicin, cytarabine, etoposide, boron, mannitol or bortezomib

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Concurrent radiotherapy allowed for patients who present with a chloroma that is
producing or threatens to produce an irreversible neurologic deficit

- Recovered from all prior chemotherapy, immunotherapy, or radiotherapy

- More than 2 weeks since prior cytotoxic chemotherapy (4 weeks for nitrosoureas),
except for hydroxyurea, which is allowed up to 24 hours prior to first dose of study
drug, and intrathecal chemotherapy, which is allowed immediately up to administration
of study drug

- Prior steroid allowed as clinically indicated for patients with asthma

- Hydrocortisone and methylprednisolone allowed as premedication in patients with a
history of severe allergic reactions

- At least 7 days since prior biologic agents, such as steroids, retinoids, or donor
lymphocyte infusion without conditioning

- At least 2 weeks since prior local palliative radiotherapy (small port)

- At least 8 weeks since prior craniospinal radiotherapy or ≥ 50% radiation of pelvis

- At least 6 weeks since prior other bone marrow radiation

- At least 1 day since prior green tea containing products, any products containing
vitamin C, flavanoids or other antioxidants (e.g., vitamins, herbal supplements), and
foods with high vitamin C content

- No prior radiotherapy to > 25% of lung volume

- No prior total-body irradiation as part of a hematopoietic stem cell conditioning
regimen

- At least 2 months since prior stem cell transplantation

- No concurrent graft-vs-host disease prophylactic medication

- No prior bortezomib or other proteasome inhibitors

- No other concurrent investigational drugs

- More than 4 days since prior growth factors that support platelet or white cell number
or function

- No concurrent enzyme-inducing anticonvulsant medications known to be potent inducers
of the cytochrome P450 system, including phenytoin, carbamazepine, and phenobarbital

- Concurrent benzodiazepines and gabapentin allowed

- No concurrent grapefruit juice with bortezomib

- No other concurrent cancer chemotherapy or immunomodulating agents

- No concurrent corticosteroids as anti-emetic therapy

- Concurrent corticosteroids therapy allowed as treatment or prophylaxis for
anaphylactic reactions, symptoms of cytarabine syndrome, and as treatment for
presumptive bortezomib-induced pulmonary toxicity.
We found this trial at
78
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Fort Lauderdale, Florida 33316
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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Charlotte, NC
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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3533 South Alameda Street
Corpus Christi, Texas 78411
(361) 694-5000
Driscoll Children's Hospital Driscoll Children's Hospital was built because Clara Driscoll's will requested that a...
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9981 S Healthpark Dr # 465
Fort Myers, Florida 33908
239-343-5000
Lee Memorial Health System Our origins can be traced to the Fall of 1916 when...
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100 Michigan Street Northeast
Grand Rapids, Michigan 49503
616.391.9000
Helen DeVos Children's Hospital at Spectrum Health Helen DeVos Children's Hospital, located in Grand Rapids,...
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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2500 Campus Rd
Honolulu, Hawaii 96822
(808) 956-8111
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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529 West Markham Street
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262 Danny Thomas Pl
Memphis, Tennessee 38105
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747 52nd St
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1201 W La Veta Ave
Orange, California 92868
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Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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1717 South Orange Avenue # 100
Orlando, Florida 32806
(407) 650-7000
Nemours Children's Clinic - Orlando Located near downtown Orlando, Nemours Children’s Clinic, Orlando is a...
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5153 North 9th Avenue
Pensacola, Florida 32504
(850) 505-4700
Nemours Children's Clinic - Pensacola Nemours Children’s Clinic, Pensacola serves children and families in northwest...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
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100 N Mario Capecchi Dr
Salt Lake City, Utah 84132
(801) 662-1000
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1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
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Albuquerque, New Mexico 87131
(505) 277-0111
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1540 East Hospital Drive
Ann Arbor, Michigan 48109
(877) 475-6688
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2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Chicago, Illinois 60614
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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5 Richland Medical Park Dr
Columbia, South Carolina 29203
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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4760 Sunset Blvd
Downey, California 90027
(323) 783-6151
Southern California Permanente Medical Group We
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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835 S Van Buren St
Green Bay, Wisconsin 54301
(920) 433-0111
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-8521
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
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Jacksonville, Florida 32207
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2018 W Clinch Ave
Knoxville, Tennessee 37916
(865) 541-8000
East Tennessee Children's Hospital East Tennessee Children's Hospital is a not-for-profit, private, independent pediatric medical...
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601 South Rancho Drive Suite C-26
Las Vegas, Nevada 89106
(702) 384-0013
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Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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2801 Atlantic Ave
Long Beach, California 90806
(562) 933-5437
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Marshfield, Wisconsin 54449
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Milwaukee, Wisconsin 53226
Midwest Children's Cancer Center The Medical College of Wisconsin Cancer Center is dedicated to providing...
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2525 Chicago Ave
Minneapolis, Minnesota 55404
(612) 813-6000
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2450 Riverside Ave
Minneapolis, Minnesota 55454
(612) 273-3000
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One Robert Wood Johnson Place
New Brunswick, New Jersey 08901
(732) 828-3000
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
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630 W 168th St
New York, New York
212-305-2862
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201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
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Perth, Western Australia
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
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3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
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2801 N Gantenbein Ave
Portland, Oregon 97227
(503) 413-2200
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Rochester, Minnesota 55905
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
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Saint Petersburg, Florida 33701
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505 Parnassus Ave
San Francisco, California 94143
(415) 476-1000
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4700 Waters Ave
Savannah, Georgia 31404
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Sioux Falls, South Dakota 57117
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327 W Calhoun Ave
Springfield, Illinois 62702
(217) 545-0223
Southern Illinois University From its humble beginnings as the state's second teachers college - founded...
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99 Beauvoir Avenue
Summit, New Jersey 07902
(908) 522-2000
Overlook Hospital Atlantic Health System
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3001 W Dr Martin Luther King Jr Blvd
Tampa, Florida 33607
(813) 554-8500
Saint Joseph Children's Hospital of Tampa Parents have the confidence of knowing that the specialized...
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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