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Adult Acute Monoblastic Leukemia (M5a)Phase 2NCT00666588

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

A Phase 2 study testing idarubicin, cytarabine and bortezomib in people with Adult Acute Monoblastic Leukemia (M5a) and Adult Acute Monocytic Leukemia (M5b), run by National Cancer Institute (NCI) at 82 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 1 year to 21 years
What is being tested?
idarubicin, cytarabine and bortezomib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
82 sitesin 3 countries
Study dates
Apr 2008to Dec 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 81Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

82 sites in 3 countries.

82 sites in 3 countries

United States77 sites

  • Children's Hospital Medical Center of Akron

    Akron, Ohio, 44308

  • University of New Mexico

    Albuquerque, New Mexico, 87106

  • C S Mott Children's Hospital

    Ann Arbor, Michigan, 48109

  • Children's Healthcare of Atlanta - Egleston

    Atlanta, Georgia, 30322

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35293

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Childrens Memorial Hospital

    Chicago, Illinois, 60614

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Rainbow Babies and Childrens Hospital

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Palmetto Health Richland

    Columbia, South Carolina, 29203

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78411

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • The Children's Medical Center of Dayton

    Dayton, Ohio, 45404

  • Southern California Permanente Medical Group

    Downey, California, 90242

  • Michigan State University - Breslin Cancer Center

    East Lansing, Michigan, 48824-1313

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • Lee Memorial Health System

    Fort Myers, Florida, 33901

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104

  • Helen DeVos Children's Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • Saint Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106

  • Penn State Hershey Children's Hospital

    Hershey, Pennsylvania, 17033

  • University of Hawaii

    Honolulu, Hawaii, 96813

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Nemours Children's Clinic - Jacksonville

    Jacksonville, Florida, 32207-8426

  • The Childrens Mercy Hospital

    Kansas City, Missouri, 64108

  • East Tennessee Childrens Hospital

    Knoxville, Tennessee, 37916

  • Nevada Cancer Research Foundation CCOP

    Las Vegas, Nevada, 89106

  • University of Kentucky

    Lexington, Kentucky, 40536

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Miller Children's Hospital

    Long Beach, California, 90806

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • Midwest Children's Cancer Center

    Milwaukee, Wisconsin, 53226

  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    Minneapolis, Minnesota, 55404

  • University of Minnesota Medical Center-Fairview

    Minneapolis, Minnesota, 55455

  • UMDNJ - Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08903

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Columbia University Medical Center

    New York, New York, 10032

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Children's Hospital and Research Center at Oakland

    Oakland, California, 94609-1809

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7830

  • Childrens Hospital of Orange County

    Orange, California, 92868-3874

  • Nemours Childrens Clinic - Orlando

    Orlando, Florida, 32806

  • Packard Children's Hospital Stanford University

    Palo Alto, California, 94304

  • Nemours Children's Clinic - Pensacola

    Pensacola, Florida, 32504

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Phoenix Childrens Hospital

    Phoenix, Arizona, 85016

  • Childrens Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

  • Legacy Emanuel Hospital and Health Center

    Portland, Oregon, 97227

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Primary Children's Medical Center

    Salt Lake City, Utah, 84113

  • University of Texas Health Science Center

    San Antonio, Texas, 78229-3900

  • University of California San Francisco Medical Center

    San Francisco, California, 94143

  • Memorial Health University Medical Center

    Savannah, Georgia, 31403

  • Seattle Children's Hospital

    Seattle, Washington, 98105

  • Sanford University of South Dakota Medical Center

    Sioux Falls, South Dakota, 57117-5134

  • Southern Illinois University

    Springfield, Illinois, 62702

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • All Children's Hospital

    St. Petersburg, Florida, 33701

  • Overlook Hospital

    Summit, New Jersey, 07902

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • Saint Joseph Children's Hospital of Tampa

    Tampa, Florida, 33607

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

  • Alfred I duPont Hospital for Children

    Wilmington, Delaware, 19803

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada4 sites

  • IWK Health Centre

    Halifax, Nova Scotia, B3J 3G9

  • Hospital Sainte-Justine

    Montreal, Quebec, H3T 1C5

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Australia1 site

  • Princess Margaret Hospital for Children

    Perth, Western Australia, 6008

Other trials in Australia

About this study

Official title: 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

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
idarubicin, cytarabine, bortezomib, etoposide, laboratory biomarker analysis
Medical subject headings
Leukemia, Monocytic, Acute, Leukemia, Myeloid, Acute, Congenital Abnormalities, Leukemia, Myelomonocytic, Acute, Leukemia, Eosinophilic, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • idarubicinDrug

    Also called 4-demethoxydaunorubicin, 4-DMDR, DMDR, IDA

    Given IV

  • cytarabineDrug

    Also called ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U

    Given IV or IT

  • bortezomibDrug

    Also called LDP 341, MLN341, VELCADE

    Given IV

  • etoposideDrug

    Also called EPEG, VP-16, VP-16-213

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00666588
Study groupRoleWhat they receive
Bortezomib 1.3mg/m2-assess efficacy-low anthracycline exposureExperimentalBortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.
Receives: Drug: idarubicin; Drug: cytarabine; Drug: bortezomib; Other: laboratory biomarker analysis
Bortezomib 1.0mg/m2-assess feasibility high anthracycline expExperimentalBortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: cytarabine; Drug: bortezomib; Drug: etoposide; Other: laboratory biomarker analysis
Bortezomib 1.3 mg/m2-assess feasibility high anthracycline expExperimentalBortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).
Receives: Drug: cytarabine; Drug: bortezomib; Drug: etoposide; Other: laboratory biomarker analysis
Bortezomib 1.3 mg/m2-assess efficacy high anthracycline expExperimentalBortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity
Receives: Drug: cytarabine; Drug: bortezomib; Drug: etoposide; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicity

    Number of participants with dose limiting toxicity.

    Measured: During Course 1

  2. Overall Response (Complete Remission [CR] and CR With Partial Recovery [CRp]) During Course 1

    Overall response (complete remission [CR] and CR with partial recovery [CRp]) during course 1.

    Measured: After course 1

Secondary outcomes (4)

  1. NF-kB Activity by Enzyme-linked Immunosorbent Assay (ELISA)

    NF-kB activity will be measured as a continuous variable (ng NF-kB/Mg protein). Differences in NF-κB activity between time points will be assessed using summary statistics such as mean, standard deviation, and range. We may perform exploratory analyses to determine if single time point measurements, or the difference between time points, correlate with treatment response.

    Measured: At baseline, prior to and up to 24 hours after bortezomib treatment

  2. Proteasome Inhibition Activity

    Mean and standard deviation of β1 and β5- Results are ratios (proteasome subunit/β-actin based on loading of 15 µg total protein, normalized to CEM).

    Measured: At baseline

  3. Protein Expression Assessed by Western Blot

    Relative expression of apoptotic and cell cycle proteins will be characterized using descriptive statistics. If differences are noted between pre and post-treatment protein expression, pairwise comparisons will be made using paired t-test or an equivalent nonparametric test if the data are non-normally distributed. The normality assumption will be assessed on the log-transformed data prior to paired t-test evaluation.

    Measured: At baseline, prior to and up to 24 hours after bortezomib treatment

  4. Feasibility of Stem Cell Quantitation: Percentage of Leukemia Initiation Cells (LIC) Depletion

    Descriptive statistics to assess mean +/- standard deviation for the percentage leukemia initiation cells (LIC) depletion.

    Measured: At baseline and after completion of course 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00666588
Sponsor's protocol ID
NCI-2009-00323
Other IDs
U10CA098543, CDR0000594224, COG-AAML07P1, NCI-2009-00323
Status last verified
May 2018
First submitted
24 Apr 2008
Last updated
22 May 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing idarubicin, cytarabine and bortezomib in people with Adult Acute Monoblastic Leukemia (M5a) and Adult Acute Monocytic Leukemia (M5b), run by National Cancer Institute (NCI) at 82 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 81 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity (time frame: During Course 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00666588.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2018.

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