A Study of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Eisai Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00211185
First received: September 13, 2005
Last updated: August 27, 2009
Last verified: March 2008
  Purpose

Study of ONTAK and CHOP (chemotherapy drugs) to find out their ability to make Peripheral T-cell lymphoma disappear (for any period of time) and potentially lengthen life. The study will also compare what kind of side effects these drugs cause and how often they occur. The hypothesis is that patients with newly diagnosed peripheral T-Cell lymphoma, when given ONTAK + CHOP, will tolerate the treatment and will have a 20% improvement in response rate when compared to CHOP alone.


Condition Intervention Phase
Lymphoma, T-Cell, Peripheral
Drug: ONTAK (denileukin diftitox, DAB389 IL-2)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Phase II Study to Determine the Safety and Efficacy of the Combination of ONTAK With CHOP in Peripheral T-Cell Lymphoma.

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Safety of the combination of ONTAK + CHOP is assessed every 3 weeks for 18 weeks using measures such as ECG, physical exam, weight and performance status, vital signs, and blood chemistry/hematology (every 6 weeks). [ Time Frame: Every 3 weeks or as needed. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The response rate for the combination is assessed every 6 weeks using measures such as radiological tests for measurable disease and tumor measurements. [ Time Frame: Every 6 weeks. ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2004
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ONTAK (denileukin diftitox, DAB389 IL-2)
Ontak + CHOP every 3 weeks.

  Eligibility

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

Inclusion Criteria:

  • Pathological diagnosis of peripheral T-cell lymphoma of one of the following histologies as per the REAL classification: peripheral T-cell lymphoma (unspecified), anaplastic large cell lymphoma CD30+, angioimmunoblastic T-cell lymphoma, nasal/nasal type T/NK cell lymphoma, intestinal T-cell lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitic T-cell lymphoma.
  • Treatment naïve except for prior radiation or a single cycle of CHOP.
  • Patients must have at least one clear-cut bidimensionally measurable site by physical exam and/or computed tomography.
  • Prior radiation therapy for localized disease is allowed as long as the irradiated area is not at the mediastinal area or at the only site of measurable disease. Therapy must be completed at least 4 weeks before the enrollment in study.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • At least 18 years of age.
  • Adequate bone marrow reserve, indicated by absolute neutrophil count (ANC) > or equal to 1000/microL, platelets > or equal to 50,000/microL (25,000/MicroL if thrombocytopenia secondary to bone marrow involvement by lymphoma), and hemoglobin > or equal to 8 g/dL.
  • Adequate liver function, indicated by bilirubin < or equal to 1.5 times the upper limit of normal (ULN), alanine transaminase (ALT) < or equal to 2 times the ULN or aspartate transaminase (AST) < or equal to 2.0 times the ULN, and albumin > or equal to 3.0 g/dL.
  • Adequate renal function, indicated by serum creatinine < or equal to 2.5 mg/dL.
  • Women of childbearing potential and sexually active males agree to use an accepted and effective method of contraception.
  • Able to give informed consent.

Exclusion Criteria:

  • Diagnosis of Mycosis Fungoides or Sezary Syndrome.
  • Active Hepatitis B or Hepatitis C infection.
  • Known HIV infection (HIV testing is not required).
  • Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections have resolved and any continuing treatment if appropriate is given on an outpatient basis.
  • Previous doxorubicin therapy with cumulative dose of >100 mg/m2.
  • Left Ventricular Ejection Fraction (LVEF) < 50%.
  • Patients who are pregnant or breast-feeding.
  • Prior invasive malignancies within past 5 years.
  • Allergy to or history of allergy to diphtheria toxin or IL-2.
  • Preexisting severe cardiovascular disease (e.g. CHF, Severe CAD, cardiomyopathy, MI within the past 3 months, arrhythmia) requiring ongoing treatment.
  • Ongoing antineoplastic chemotherapy, radiation, hormonal (excluding contraceptives) or immunotherapy, or investigational medications within past 30 days.
  • Patients with deep vein thrombosis within 3 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00211185

  Hide Study Locations
Locations
United States, Alabama
Birmingham Hematology and Oncology
Birmingham, Alabama, United States, 35205
United States, Arizona
Hematology Oncology Associates
Phoenix, Arizona, United States, 85012
United States, California
Stanford Cancer Center
Stanford, California, United States, 94305-5826
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06250
United States, Florida
Ocala Oncology Center
Ocala, Florida, United States, 34474
Cancer Centers of Florida, P.A.
Ocoee, Florida, United States, 34761
United States, Illinois
Hematology Oncology Associates of IL
Chicago, Illinois, United States, 60611
Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
Cancer Care & Hematology Specialists of Chicagoland
Niles, Illinois, United States, 60714
United States, Iowa
Siouxland Hematology Oncology
Sioux City, Iowa, United States, 51101
United States, Kansas
Kansas City Cancer Centers
Lenexa, Kansas, United States, 66214
United States, Massachusetts
Dana Farber/ Harvard Cancer Center
Boston, Massachusetts, United States, 02115
New England Medical Center
Boston, Massachusetts, United States
United States, Minnesota
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States, 55404
United States, Missouri
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
Kansas City Cancer Centers
Kansas City, Missouri, United States, 64111
St. Joseph Oncology Inc.
St. Joseph, Missouri, United States, 64507
Arch Medical Services
St. Louis, Missouri, United States, 63141
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Hematology Oncology Associates of NNJ
Morristown, New Jersey, United States, 07960
United States, New Mexico
New Mexico Cancer Care Associates
Santa Fe, New Mexico, United States, 87505
United States, New York
New York Oncology Hematology, P.C.
Albany, New York, United States, 12208
United States, North Carolina
Raleigh Hematology Oncology Associates
Cary, North Carolina, United States, 27511
United States, Ohio
Barrett Cancer Center-University of Cincinnati
Cincinnati, Ohio, United States, 45206
Greater Dayton Cancer Center
Kettering, Ohio, United States, 45409
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Texas
Texas Cancer Center
Arlington, Texas, United States, 76014
Marnie McFaddin Ward Cancer Center
Beaumont, Texas, United States, 77702-1449
Texas Oncology,P.A.
Bedford, Texas, United States, 76022
The Texas Cancer Center
Dallas, Texas, United States, 75237
Texas Cancer Center at Medical City
Dallas, Texas, United States, 75230-2510
El Paso Cancer Treatment Center
El Paso, Texas, United States, 79915
Texas Oncology
Fort Worth, Texas, United States, 76104
Texas Oncology
Garland, Texas, United States, 75042-5788
Longview Cancer Center
Longview, Texas, United States, 75601
Allison Cancer Center
Midland, Texas, United States, 79701-5946
West Texas Cancer Center
Odessa, Texas, United States, 79761
HOAST Medical Dr.
San Antonio, Texas, United States, 78229
Tyler Cancer Center
Tyler, Texas, United States, 75702
Waco Cancer Care and Research Center
Waco, Texas, United States, 76712
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Oncology and Hematology Associates of SW VA Inc.
Salem, Virginia, United States, 24153
United States, Washington
Puget Sound Cancer Center
Edmonds, Washington, United States, 98026
Cancer Care Northwest
Spokane, Washington, United States, 99218
Northwest Cancer Specialists
Vancouver, Washington, United States, 98684
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Chair: Francine Foss, M.D. Yale University
  More Information

Publications:
Francine M. Foss, Nelida Sjak-Shie, Andre Goy, Ranjana Advani, Eric Jacobsen, and Mark Acosta A Phase II Study of Denileukin Diftitox (Ontak®) with CHOP Chemotherapy in Patients with Newly-Diagnosed Aggressive T-Cell Lymphomas, the CONCEPT Trial: Interim Analysis. Blood (ASH Annual Meeting Abstracts), Nov 2006; 108: 2461.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mark Acosta, Eisai Medical Research Inc.
ClinicalTrials.gov Identifier: NCT00211185     History of Changes
Other Study ID Numbers: #35
Study First Received: September 13, 2005
Last Updated: August 27, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Denileukin diftitox
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014