Know Cancer

or
forgot password

Phase II Trial of the Aurora Kinase A Inhibitor MLN8237, in Relapsed or Refractory Peripheral T-Cell Non-Hodgkin Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Hepatosplenic T-cell Lymphoma, Peripheral T-cell Lymphoma, Recurrent Adult Non-Hodgkin Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma

Thank you

Trial Information

Phase II Trial of the Aurora Kinase A Inhibitor MLN8237, in Relapsed or Refractory Peripheral T-Cell Non-Hodgkin Lymphoma


OBJECTIVES:

I. To estimate the objective response rate (complete responses [CR] + partial responses
[PR]) after 4 courses of treatment with alisertib (MLN8237) in patients with relapsed or
refractory peripheral T-cell non-Hodgkin lymphoma.

II. To assess overall survival (OS) and progression-free survival (PFS) in this patient
population.

III. To evaluate the safety and tolerability of MLN8237 treatment for this patient
population.

IV. To explore the association between pre-treatment aurora kinase A expression in tumor
biopsies as measured by fluorescence in situ hybridization (FISH) and objective response
rate in patients with peripheral T-cell lymphomas (PTCL) treated with MLN8237. (exploratory)
IV. To investigate the copy number, mutational status, expression of aurora kinase (A, B,
and C) and associated signaling pathways in PTCL utilizing tissue microarray analysis (TMA)
before and after treatment with MLN8237.

EXPLORATORY OBJECTIVES:

I. To investigate changes in the serum cytokine profile pre- and post- aurora kinase
Inhibitor treatment.

II. To evaluate serum markers of apoptosis pre- and post- aurora kinase inhibitor treatment
as pharmacodynamic markers of efficacy.

OUTLINE:

Patients receive alisertib orally (PO) twice daily (BID) on days 1-7. Treatment repeats
every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 4 months for 2 years.


Inclusion Criteria:



- Patients must have histologically or cytologically confirmed relapsed/refractory
non-Hodgkin lymphoma (NHL) with any of the following T-cell histologies:

- Peripheral T-cell NHL (PTCL) not otherwise specified (NOS)

- Anaplastic large cell T-cell lymphoma (ALCL) that is anaplastic lymphoma kinase
either positive or negative

- Angioimmunoblastic T-cell NHL

- Subcutaneous panniculitis-like T-cell lymphoma

- Enteropathy-associated T-cell NHL

- Hepatosplenic T-cell lymphomas

- Extranodal NK/T-cell lymphoma, nasal type

- Adult T-cell leukemia/lymphoma

- Unclassifiable PTCL

- Transformed cutaneous T-cell lymphoma (CTCL) to PTCL with systemic involvement
(not local skin transformation)

- No other histologies are eligible; examples of ineligible histologies include:
T-cell prolymphocytic leukemia, T-cell large granular lymphocytic leukemia,
NK-cell leukemia, mycosis fungoides, Sezary syndrome, lymphomatoid papulosis,
and primary CTCL

- Patients must have received at least one course of prior systemic therapy which may
include chemotherapy, antibody therapy, or immunotherapy; for all forms of systemic
therapy, patients must have completed therapy at least 21 days prior to registration;
patients must not be within 84 days of radioimmunotherapy; steroids at a low dose for
control of itching (up to the equivalent of 20 mg of prednisone daily) are allowed

- Adequate sections and a paraffin block from the relapsed/refractory specimen must be
submitted for review by the lymphoma pathology group; an adequate biopsy requires
sufficient tissue to establish the architecture and a Revised European American
Lymphoma (REAL) or World Health Organization (WHO) histologic subtype with certainty;
thus, core biopsies, especially multiple core biopsies MAY be adequate; whereas,
needle aspirations or cytologies are not adequate

- Patients must have bidimensionally measurable disease

- Patients who also have non-measurable disease in addition to measurable disease
must have all non-measurable disease assessed within 42 days prior to
registration

- Patients must have a bilateral or unilateral bone marrow aspirate and biopsy
performed within 42 days prior to registration

- Patients must not have clinical evidence of central nervous system involvement by
lymphoma

- Patients must be able to swallow tablets

- Patients known to be human immunodeficiency virus (HIV)-positive must not have
multi-drug resistant HIV infection, CD4 counts < 150/mcL, or other concurrent
acquired immunodeficiency syndrome (AIDS)-defining conditions

- Absolute granulocyte count >= 1,000 cells/mcL

- Platelet count >= 75,000 cells/mcL (patients with documented marrow involvement may
be transfused to this value)

- Serum bilirubin =< 2 times institutional upper limit of normal

- Patients must have a Zubrod performance status of 0, 1, or 2

- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
stage I or II cancer from which the patient is currently in complete remission, or
any other cancer from which the patient has been disease free for five years

- Pregnant or nursing women may not participate

- Women or men of reproductive potential may not participate unless they have agreed to
use an effective contraceptive method

- Patients may have received prior radiation in combination with systemic therapy;
patients must not be within 21 days of external-beam radiation therapy

- Patients must not have received a previous allogeneic stem cell transplant or be
within 90 days of an autologous stem cell transplant

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (CR and PR)

Outcome Time Frame:

Up to 2 years

Safety Issue:

No

Principal Investigator

Paul Barr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-03551

NCT ID:

NCT01466881

Start Date:

October 2011

Completion Date:

Related Keywords:

  • Adult Nasal Type Extranodal NK/T-cell Lymphoma
  • Anaplastic Large Cell Lymphoma
  • Angioimmunoblastic T-cell Lymphoma
  • Hepatosplenic T-cell Lymphoma
  • Peripheral T-cell Lymphoma
  • Recurrent Adult Non-Hodgkin Lymphoma
  • Recurrent Adult T-cell Leukemia/Lymphoma
  • Immunoblastic Lymphadenopathy
  • Leukemia
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Extranodal NK-T-Cell

Name

Location

Louisiana State University New Orleans, Louisiana  70112-2282
Memorial Sloan Kettering Cancer Center New York, New York  10021
Washington University School of Medicine Saint Louis, Missouri  63110
Hurley Medical Center Flint, Michigan  48503
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
Genesys Hurley Cancer Institute Flint, Michigan  48503
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Fairview Ridges Hospital Burnsville, Minnesota  55337
Hutchinson Area Health Care Hutchinson, Minnesota  55350
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Avera Cancer Institute Sioux Falls, South Dakota  57105
Loyola University Medical Center Maywood, Illinois  60153
Sutter Health Western Division Cancer Research Group Greenbrae, California  94904
Lehigh Valley Hospital Allentown, Pennsylvania  18103
Via Christi Regional Medical Center Wichita, Kansas  67214
Weill Medical College of Cornell University New York, New York  10021
University of Wisconsin Hospital and Clinics Madison, Wisconsin  53792-0001
Great Falls Clinic Great Falls, Montana  59405
Cancer Center of Kansas - Chanute Chanute, Kansas  66720
Cancer Center of Kansas - Dodge City Dodge City, Kansas  67801
Cancer Center of Kansas - Newton Newton, Kansas  67114
Cancer Center of Kansas - Salina Salina, Kansas  67042
Cancer Center of Kansas - Wellington Wellington, Kansas  67152
Associates in Womens Health Wichita, Kansas  67203
Cancer Center of Kansas - Winfield Winfield, Kansas  67156
Bozeman Deaconess Hospital Bozeman, Montana  59715
Big Sky Oncology Great Falls, Montana  59405
Kalispell Medical Oncology Kalispell, Montana  59901
Kalispell Regional Medical Center Kalispell, Montana  59901
Welch Cancer Center Sheridan, Wyoming  82801
City of Hope Medical Center Duarte, California  91010
Sutter Solano Medical Center Vallejo, California  94589
Beebe Medical Center Lewes, Delaware  19958
Hematology and Oncology Associates Chicago, Illinois  60611
Iredell Memorial Hospital Statesville, North Carolina  28677
Bismarck Cancer Center Bismarck, North Dakota  58501
Mercy Hospital Coon Rapids, Minnesota  55433
Hematology Oncology Associates of Illinois-Highland Park Highland Park, Illinois  60035
Ottumwa Regional Health Center Ottumwa, Iowa  52501
Saint Joseph Mercy Hospital Ann Arbor, Michigan  48106
Fairview-Southdale Hospital Edina, Minnesota  55435
Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Regions Hospital Saint Paul, Minnesota  55101
Saint Francis Regional Medical Center Shakopee, Minnesota  55379
Rice Memorial Hospital Willmar, Minnesota  56201
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Lawrence Memorial Hospital Lawrence, Kansas  66044
Menorah Medical Center Overland Park, Kansas  66209
North Kansas City Hospital Kansas City, Missouri  64116
Research Medical Center Kansas City, Missouri  64132
Saint Luke's East - Lee's Summit Lee's Summit, Missouri  64086
Heartland Regional Medical Center Saint Joseph, Missouri  64506
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
Northern Montana Hospital Havre, Montana  59501
Rocky Mountain Oncology Casper, Wyoming  82609
Union Hospital of Cecil County Elkton MD, Maryland  21921
Queen's Medical Center Honolulu, Hawaii  96813
Providence Hospital Mobile, Alabama  36608
Northwestern University Chicago, Illinois  60611
Kapiolani Medical Center at Pali Momi Aiea, Hawaii  96701
Kapiolani Medical Center for Women and Children Honolulu, Hawaii  96826
Hennepin County Medical Center Minneapolis, Minnesota  
Saint Louis University Hospital St. Louis, Missouri  63110-0250
University of Rochester Rochester, New York  14642
Saint Alphonsus Regional Medical Center Boise, Idaho  83706
Emory University Atlanta, Georgia  30322
University of Arizona Health Sciences Center Tucson, Arizona  85724
Straub Clinic and Hospital Honolulu, Hawaii  96813
University of Massachusetts Medical School Worcester, Massachusetts  01605
Cancer Center of Kansas - McPherson McPherson, Kansas  67460
California Pacific Medical Center San Francisco, California  94115
Mid Dakota Clinic Bismarck, North Dakota  58501
Wichita CCOP Wichita, Kansas  67214-3882
Montana Cancer Consortium CCOP Billings, Montana  59101
Metro-Minnesota CCOP St. Louis Park, Minnesota  
Lakeview Hospital Stillwater, Minnesota  55082
Tulane University Health Sciences Center New Orleans, Louisiana  70112
Montana Cancer Specialists Missoula, Montana  59807-7877
University of Cincinnati Cincinnati, Ohio  45267-0502
Castle Medical Center Kailua, Hawaii  96734
New Ulm Medical Center New Ulm, Minnesota  56073
Mills - Peninsula Hospitals Burlingame, California  94010
Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Lombardi Comprehensive Cancer Center at Georgetown University Washington, District of Columbia  20057
Oncare Hawaii Inc-POB II Honolulu, Hawaii  96813
Oncare Hawaii Inc-Kuakini Honolulu, Hawaii  96817
University of Hawaii Honolulu, Hawaii  96813
Provena Saint Mary's Hospital Kankakee, Illinois  60901
North Shore Hematology Oncology Libertyville, Illinois  60048
Hematology Oncology Associates of Illinois - Skokie Skokie, Illinois  60076
McFarland Clinic Ames, Iowa  50010
Cancer Center of Kansas - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas-Kingman Kingman, Kansas  67068
Cancer Center of Kansas - Parsons Parsons, Kansas  67357
Cancer Center of Kansas - Pratt Pratt, Kansas  67124
Cancer Center of Kansas-Wichita Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas - Main Office Wichita, Kansas  67214
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor, Michigan  48106
Oakwood Hospital Dearborn, Michigan  48123
Saint John Hospital and Medical Center Detroit, Michigan  48236
Allegiance Health Jackson, Michigan  49201
Sparrow Hospital Lansing, Michigan  48912
Saint Mary Mercy Hospital Livonia, Michigan  48154
Saint Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Saint Joseph Mercy Port Huron Port Huron, Michigan  48060
Saint Mary's of Michigan Saginaw, Michigan  48601
Saint John Macomb-Oakland Hospital Warren, Michigan  48093
Unity Hospital Fridley, Minnesota  55432
Saint John's Hospital - Healtheast Maplewood, Minnesota  55109
Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota  55109
North Memorial Medical Health Center Robbinsdale, Minnesota  55422
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota  55416
Minnesota Oncology and Hematology PA-Woodbury Woodbury, Minnesota  55125
Saint Luke's Cancer Institute Kansas City, Missouri  64111
Saint Luke's Hospital of Kansas City Kansas City, Missouri  64111
Saint Joseph Health Center Kansas City, Missouri  64114
Liberty Radiation Oncology Clinic Kansas City, Missouri  64116
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield Springfield, Missouri  65802
Saint John's Hospital Springfield, Missouri  65804
Cox Medical Center Springfield, Missouri  65807
Hematology-Oncology Centers of the Northern Rockies PC Billings, Montana  59101
Saint Vincent Healthcare Billings, Montana  59101
Billings Clinic Billings, Montana  59107-7000
Saint James Community Hospital and Cancer Treatment Center Butte, Montana  59701
Benefis Healthcare- Sletten Cancer Institute Great Falls, Montana  59405
Saint Peter's Community Hospital Helena, Montana  59601
Glacier Oncology PLLC Kalispell, Montana  59901
Saint Patrick Hospital - Community Hospital Missoula, Montana  59802
Cooper Hospital University Medical Center Camden, New Jersey  08103
New York University Langone Medical Center New York, New York  10016
Saint Alexius Medical Center Bismarck, North Dakota  58501
Salem Hospital Salem, Oregon  97309
Audie L Murphy Veterans Affairs Hospital San Antonio, Texas  78209
University Hospital San Antonio, Texas  78229
Cancer Center of Kansas-Liberal Liberal, Kansas  67901
Roper Hospital Charleston, South Carolina  29401
Arizona Cancer Center at University Medical Center North Tucson, Arizona  85719
Kuakini Medical Center Honolulu, Hawaii  96817
Arizona Cancer Center at UMC Orange Grove Tucson, Arizona  85704
Wilcox Memorial Hospital and Kauai Medical Clinic Lihue, Hawaii  96766-1099
Saint Luke's South Hospital Overland Park, Kansas  66213
Kansas City CCOP Prairie Village, Kansas  66208
Hematology and Oncology Clinic Baton Rouge, Louisiana  70809
Heartland Hematology and Oncology Associates Incorporated Kansas City, Missouri  64118
Saint Joseph Oncology Inc Saint Joseph, Missouri  64507
Alta Bates Summit Medical Center-Herrick Campus Berkeley, California  94704
Southwest Oncology Group San Antonio, Texas  78245
Southwest Oncology Group (SWOG) Research Base San Antonio, Texas  78245
Genesys Regional Medical Center-West Flint Campus Flint, Michigan  48532
Sanford Bismarck Medical Center Bismarck, North Dakota  58501
Christiana Care Health System-Christiana Hospital Newark, Delaware  19718
Illinois Cancer Specialists-Niles Niles, Illinois  60714
Sutter Pacific Medical Foundation Santa Rosa, California  95403
OnCare Hawaii-Liliha Honolulu, Hawaii  96817-3169
Oncare Hawaii Inc - Kapiolani Medical Center at Pali Momi Aiea, Hawaii  96701