A Study of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell Lymphoma
This trial is active, not recruiting.
|Condition||lymphoma, t-cell, peripheral|
|Treatment||ontak (denileukin diftitox, dab389 il-2)|
|Start date||March 2004|
|End date||August 2008|
|Trial size||50 participants|
|Trial identifier||NCT00211185, #35|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Birmingham, AL||Birmingham Hematology and Oncology||no longer recruiting|
|Phoenix, AZ||Hematology Oncology Associates||no longer recruiting|
|Stanford, CA||Stanford Cancer Center||no longer recruiting|
|Denver, CO||Rocky Mountain Cancer Center||no longer recruiting|
|New Haven, CT||Yale University School of Medicine||no longer recruiting|
|Ocala, FL||Ocala Oncology Center||no longer recruiting|
|Ocoee, FL||Cancer Centers of Florida, P.A.||no longer recruiting|
|Chicago, IL||Hematology Oncology Associates of IL||no longer recruiting|
|Chicago, IL||Robert H. Lurie Comprehensive Cancer Center||no longer recruiting|
|Chicago, IL||Rush University Medical Center||no longer recruiting|
|Niles, IL||Cancer Care & Hematology Specialists of Chicagoland||no longer recruiting|
|Sioux City, IA||Siouxland Hematology Oncology||no longer recruiting|
|Lenexa, KS||Kansas City Cancer Centers||no longer recruiting|
|Boston, MA||Dana Farber/ Harvard Cancer Center||no longer recruiting|
|Boston, MA||New England Medical Center||no longer recruiting|
|Minneapolis, MN||Minnesota Oncology Hematology, P.A.||no longer recruiting|
|Columbia, MO||Missouri Cancer Associates||no longer recruiting|
|Kansas City, MO||Kansas City Cancer Centers||no longer recruiting|
|St. Joseph, MO||St. Joseph Oncology Inc.||no longer recruiting|
|St. Louis, MO||Arch Medical Services||no longer recruiting|
|Hackensack, NJ||Hackensack University Medical Center||no longer recruiting|
|Morristown, NJ||Hematology Oncology Associates of NNJ||no longer recruiting|
|Santa Fe, NM||New Mexico Cancer Care Associates||no longer recruiting|
|Albany, NY||New York Oncology Hematology, P.C.||no longer recruiting|
|Cary, NC||Raleigh Hematology Oncology Associates||no longer recruiting|
|Cincinnati, OH||Barrett Cancer Center-University of Cincinnati||no longer recruiting|
|Kettering, OH||Greater Dayton Cancer Center||no longer recruiting|
|Philadelphia, PA||Fox Chase Cancer Center||no longer recruiting|
|Greenville, SC||Cancer Centers of the Carolinas||no longer recruiting|
|Arlington, TX||Texas Cancer Center||no longer recruiting|
|Beaumont, TX||Marnie McFaddin Ward Cancer Center||no longer recruiting|
|Bedford, TX||Texas Oncology,P.A.||no longer recruiting|
|Dallas, TX||The Texas Cancer Center||no longer recruiting|
|Dallas, TX||Texas Cancer Center at Medical City||no longer recruiting|
|El Paso, TX||El Paso Cancer Treatment Center||no longer recruiting|
|Fort Worth, TX||Texas Oncology||no longer recruiting|
|Garland, TX||Texas Oncology||no longer recruiting|
|Longview, TX||Longview Cancer Center||no longer recruiting|
|Midland, TX||Allison Cancer Center||no longer recruiting|
|Odessa, TX||West Texas Cancer Center||no longer recruiting|
|San Antonio, TX||HOAST Medical Dr.||no longer recruiting|
|Tyler, TX||Tyler Cancer Center||no longer recruiting|
|Waco, TX||Waco Cancer Care and Research Center||no longer recruiting|
|Norfolk, VA||Virginia Oncology Associates||no longer recruiting|
|Salem, VA||Oncology and Hematology Associates of SW VA Inc.||no longer recruiting|
|Edmonds, WA||Puget Sound Cancer Center||no longer recruiting|
|Spokane, WA||Cancer Care Northwest||no longer recruiting|
|Vancouver, WA||Northwest Cancer Specialists||no longer recruiting|
|Yakima, WA||Yakima Valley Memorial Hospital/North Star Lodge||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
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.
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.
Male or female participants at least 18 years old.
- 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.
- 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.
|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.|
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