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A Pilot Phase II Study to Determine the Safety and Efficacy of the Combination of ONTAK With CHOP in Peripheral T-Cell Lymphoma.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, T-Cell, Peripheral

Thank you

Trial Information

A Pilot Phase II Study to Determine the Safety and Efficacy of the Combination of ONTAK With CHOP in Peripheral T-Cell Lymphoma.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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).

Outcome Time Frame:

Every 3 weeks or as needed.

Safety Issue:

Yes

Principal Investigator

Francine Foss, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Yale University

Authority:

United States: Institutional Review Board

Study ID:

#35

NCT ID:

NCT00211185

Start Date:

March 2004

Completion Date:

Related Keywords:

  • Lymphoma, T-Cell, Peripheral
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral

Name

Location

Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Rush University Medical Center Chicago, Illinois  60612-3824
Hackensack University Medical Center Hackensack, New Jersey  07601
Virginia Oncology Associates Newport News, Virginia  23606
Rocky Mountain Cancer Center Denver, Colorado  80218
Ocala Oncology Center Ocala, Florida  34474
Cancer Centers of the Carolinas Greenville, South Carolina  29605
Missouri Cancer Associates Columbia, Missouri  65201
Stanford Cancer Center Stanford, California  94305-5824
New Mexico Cancer Care Associates Santa Fe, New Mexico  87505-7670
Tyler Cancer Center Tyler, Texas  75702
Cancer Care Northwest Spokane, Washington  99202
Northwest Cancer Specialists Vancouver, Washington  98664
New York Oncology Hematology, P.C. Albany, New York  12208
New England Medical Center Boston, Massachusetts  
Cancer Centers of Florida, P.A. Orlando, Florida  
Texas Oncology Dallas, Texas  
Minnesota Oncology Hematology, P.A. Minneapolis, Minnesota  55407
Texas Cancer Center at Medical City Dallas, Texas  75230
Allison Cancer Center Midland, Texas  79701
West Texas Cancer Center Odessa, Texas  79761
Yale University School Of Medicine New Haven, Connecticut  06520
Hematology Oncology Associates Phoenix, Arizona  85012
Greater Dayton Cancer Center Kettering, Ohio  45409
Birmingham Hematology and Oncology Birmingham, Alabama  35235
Texas Cancer Center Abilene, Texas  79606
The Texas Cancer Center Dallas, Texas  75237
El Paso Cancer Treatment Center El Paso, Texas  79915
Longview Cancer Center Longview, Texas  75601
Kansas City Cancer Centers Kansas City, Missouri  64111
Raleigh Hematology Oncology Associates Cary, North Carolina  27511
Kansas City Cancer Centers Lenexa, Kansas  
Waco Cancer Care and Research Center Waco, Texas  76712
Robert H. Lurie Comprehensive Cancer Center Chicago, Illinois  60611
Puget Sound Cancer Center Edmonds, Washington  98026
Hematology Oncology Associates of IL Chicago, Illinois  60611
Cancer Care & Hematology Specialists of Chicagoland Niles, Illinois  60714
Siouxland Hematology Oncology Sioux City, Iowa  51101
Dana Farber/ Harvard Cancer Center Boston, Massachusetts  02115
St. Joseph Oncology Inc. St. Joseph, Missouri  64507
Arch Medical Services St. Louis, Missouri  63141
Hematology Oncology Associates of NNJ Morristown, New Jersey  07960
Barrett Cancer Center-University of Cincinnati Cincinnati, Ohio  45206
Marnie McFaddin Ward Cancer Center Beaumont, Texas  77702-1449
Texas Oncology,P.A. Bedford, Texas  76022
HOAST Medical Dr. San Antonio, Texas  78229
Oncology and Hematology Associates of SW VA Inc. Salem, Virginia  24153
Yakima Valley Memorial Hospital/North Star Lodge Yakima, Washington  98902