Alisertib in Treating Patients With Relapsed or Refractory Peripheral T-Cell Non-Hodgkin Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01466881
First received: November 3, 2011
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

This phase II trial studies how well alisertib works in treating patients with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma. Alisertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.


Condition Intervention Phase
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
Drug: alisertib
Other: pharmacological study
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of the Aurora Kinase A Inhibitor MLN8237, in Relapsed or Refractory Peripheral T-Cell Non-Hodgkin Lymphoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate (CR and PR) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • PFS [ Time Frame: From date of registration to date of first observation of progressive disease or death due to any cause, assessed up to 1 year ] [ Designated as safety issue: No ]
  • Toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 39
Study Start Date: October 2011
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (alisertib)
Patients receive alisertib PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity.
Drug: alisertib
Other Names:
  • Aurora A kinase inhibitor MLN8237
  • MLN8237
Other: pharmacological study
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01466881

  Hide Study Locations
Locations
United States, Alabama
Providence Hospital
Mobile, Alabama, United States, 36608
United States, Arizona
Arizona Cancer Center at UMC Orange Grove
Tucson, Arizona, United States, 85704
Arizona Cancer Center at University Medical Center North
Tucson, Arizona, United States, 85719
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
United States, California
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States, 94704
Mills - Peninsula Hospitals
Burlingame, California, United States, 94010
City of Hope Medical Center
Duarte, California, United States, 91010
Sutter Cancer Research Consortium
Novato, California, United States, 94945
California Pacific Medical Center
San Francisco, California, United States, 94118
Sutter Pacific Medical Foundation
Santa Rosa, California, United States, 95403
Sutter Solano Medical Center
Vallejo, California, United States, 94589
United States, Connecticut
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University
Washington, District of Columbia, United States, 20057
United States, Georgia
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Hawaii
Pali Momi Medical Center
Aiea, Hawaii, United States, 96701
Oncare Hawaii Inc-Pali Momi
Aiea, Hawaii, United States, 96701
Kuakini Medical Center
Honolulu, Hawaii, United States, 96817
OnCare Hawaii-Liliha
Honolulu, Hawaii, United States, 96817-3169
Oncare Hawaii Inc-POB II
Honolulu, Hawaii, United States, 96813
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Oncare Hawaii Inc-Kuakini
Honolulu, Hawaii, United States, 96817
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, United States, 96813
University of Hawaii
Honolulu, Hawaii, United States, 96813
Castle Medical Center
Kailua, Hawaii, United States, 96734
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States, 96766
United States, Idaho
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
Northwestern University
Chicago, Illinois, United States, 60611
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, United States, 60035
Presence Saint Mary's Hospital
Kankakee, Illinois, United States, 60901
North Shore Hematology Oncology
Libertyville, Illinois, United States, 60048
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Illinois Cancer Specialists-Niles
Niles, Illinois, United States, 60714
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, United States, 60076
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
Ottumwa Regional Health Center
Ottumwa, Iowa, United States, 52501
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States, 67460
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Saint Luke's South Hospital
Overland Park, Kansas, United States, 66213
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Kansas City CCOP
Prairie Village, Kansas, United States, 66208
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Associates In Womens Health
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States, 67214
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Wichita CCOP
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Louisiana
Hematology/Oncology Clinic LLP
Baton Rouge, Louisiana, United States, 70809
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
Louisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana, United States, 71130
United States, Maryland
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
Oakwood Hospital
Dearborn, Michigan, United States, 48124
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Hurley Medical Center
Flint, Michigan, United States, 48502
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Allegiance Health
Jackson, Michigan, United States, 49201
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Missouri
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States, 64118
Saint Joseph Health Center
Kansas City, Missouri, United States, 64114
Research Medical Center
Kansas City, Missouri, United States, 64132
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Liberty Radiation Oncology Clinic
Liberty, Missouri, United States, 64068
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
Saint Joseph Oncology Inc
Saint Joseph, Missouri, United States, 64507
Saint Louis University Hospital
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield
Springfield, Missouri, United States, 65802
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
United States, Montana
Billings Clinic
Billings, Montana, United States, 59107-7000
Montana Cancer Consortium CCOP
Billings, Montana, United States, 59101
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, United States, 59102
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Great Falls Clinic
Great Falls, Montana, United States, 59405
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Big Sky Oncology
Great Falls, Montana, United States, 59405
Northern Montana Hospital
Havre, Montana, United States, 59501
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Glacier Oncology PLLC
Kalispell, Montana, United States, 59901
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
Montana Cancer Specialists
Missoula, Montana, United States, 59802
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
New York University Langone Medical Center
New York, New York, United States, 10016
Weill Medical College of Cornell University
New York, New York, United States, 10065
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Iredell Memorial Hospital
Statesville, North Carolina, United States, 28677
United States, North Dakota
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic
Bismarck, North Dakota, United States, 58501
Saint Alexius Medical Center
Bismarck, North Dakota, United States, 58501
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
United States, Oregon
Salem Hospital
Salem, Oregon, United States, 97301
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
United States, South Carolina
Roper Hospital
Charleston, South Carolina, United States, 29401
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
United States, Texas
Audie L Murphy Veterans Affairs Hospital
San Antonio, Texas, United States, 78209
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Southwest Oncology Group (SWOG) Research Base
San Antonio, Texas, United States, 78245
Southwest Oncology Group
San Antonio, Texas, United States, 78245
University Hospital
San Antonio, Texas, United States, 78229
University of Texas Health Science Center
San Antonio, Texas, United States, 78229
United States, Wisconsin
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, United States, 53038
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States, 54017
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Canada, British Columbia
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
Investigators
Principal Investigator: Paul Barr Southwest Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01466881     History of Changes
Other Study ID Numbers: NCI-2011-03551, NCI-2011-03551, SWOG-S1108, CDR0000714328, S1108, S1108, U10CA032102
Study First Received: November 3, 2011
Last Updated: April 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Immunoblastic Lymphadenopathy
Leukemia
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Extranodal NK-T-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid

ClinicalTrials.gov processed this record on April 17, 2014