Phase II Study of ONTAK in Previously Treated Patients With Low-grade Non-Hodgkin's Lymphoma (NHL)
Condition: Non-Hodgkin's Lymphoma; Lymphoma, B-cell; Lymphoma, Low-grade
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Intervention: ONTAK
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to look at the safety and effectiveness of ONTAK in previously
      treated patients with NHL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathological diagnosis of low-grade (indolent), B-cell, non-Hodgkin's lymphoma.

          -  Positive expression for CD25 of tumor cells in a lymph node biopsy as defined by
             greater than 20% of malignant cells staining for CD25 by standardized
             immunohistochemical assay.

          -  Modified Ann Arbor Stage I, II, III or IV.

          -  Patients must have received at least two but no more than five prior therapies. One
             prior therapy must have been cytotoxic chemotherapy and one prior therapy must have
             been monoclonal antibody therapy. Combination chemotherapy, including regimens used
             prior to bone marrow transplantation, will count as a single therapy for purposes of
             eligibility.

          -  Patients must have bidimensionally measurable disease.

          -  Patients must be 18 years of age or older.

          -  An ECOG performance status of 0, 1, or 2.

          -  Acceptable organ function defined as follows:

               -  absolute neutrophil count (ANC) > or = to 1,000/mm3, platelet count > or = to
                  50,000/mm3, Hemoglobin > or = to 8 g/dL;

               -  Bilirubin < or = to 1.5 times the upper limit of normal (ULN);

               -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < or = to 1.5
                  times the upper limit of normal;

               -  Serum creatinine <1.8mg/dL;

               -  Serum albumin > or = to 3.0 g/dL.

          -  New York Heart Association classification of I or II and no history of poorly
             controlled hypertension.

          -  Must be free of serious concurrent illness.

          -  Female patients must meet the following criteria:

               -  If the patient is a female of childbearing potential, she must have negative
                  serum beta human chorionic gonadotropin (B-hCG) pregnancy test within seven days
                  prior to study entry and must have used an effective means of contraception or
                  have been sexually abstinent for at least four weeks prior to the negative serum
                  pregnancy test and through to study entry.

               -  Female patients of childbearing potential must agree to practice an effective
                  method of birth control during the entire treatment period and for at least three
                  weeks after their last treatment on protocol.

        Exclusion Criteria:

          -  Patients with cutaneous T-cell lymphoma.

          -  Patients previously treated with ONTAK (DAB389lL-2) or DAB486IL-2.

          -  Inability to comply with protocol requirements for this study.

          -  Pregnant women or lactating women who are breast feeding or women planning to become
             pregnant during the treatment period or three weeks after their last treatment on
             protocol.

          -  Serious intercurrent medical illnesses or active infections requiring parenteral
             antibiotics, which would interfere with the ability of the patient to carry out the
             treatment program.

          -  Sero-positive for human immunodeficiency virus (HIV) antibody. History of ongoing
             Hepatitis B or Hepatitis C infection.

          -  Another malignancy or history of another cancer with less than five disease-free years
             (other than resected basal or squamous cell skin cancers or in situ cervical cancer).

          -  Patients with a known hypersensitivity to ONTAK or any of its components: diphtheria
             toxin, interleukin-2, or excipients.

          -  Any investigational agents within one month prior to study entry.

          -  Prior radiation therapy within four weeks of enrollment or to the only site of
             evaluable disease.