Rituximab and Denileukin Diftitox in Treating Patients With Previously Untreated Stage III or Stage IV Follicular B-Cell Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Intervention: denileukin diftitox; rituximab
Intervention MeSH terms: Rituximab; Denileukin diftitox
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma

Summary:

      RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different
      ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and
      help kill them or carry cancer-killing substances to them. Combinations of biological
      substances in denileukin diftitox may be able to carry cancer-killing substances directly to
      cancer cells. Giving rituximab together with denileukin diftitox may kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving rituximab together with denileukin
      diftitox works in treating patients with previously untreated stage III or stage IV
      follicular B-cell non-Hodgkin's lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Pathologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL)

               -  Stage III or IV disease

               -  Grade 1 or 2 disease

          -  Previously untreated disease

          -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
             conventional techniques

               -  Clearly defined bidimensional diameter ≥ 2 x 2 cm on physical examination OR >
                  2.0 cm in 1 of the dimensions by CT scan, MRI, or plain radiograph imaging

               -  Splenic enlargement may be used as a measurable parameter if the spleen is
                  palpable ≥ 3 cm below the left costal margin

          -  Circulating tumor cells < 5,000/mm³

          -  Must have paraffin-embedded tissue blocks/slides available

          -  No CNS lymphoma

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Life expectancy ≥ 1 year

          -  WBC ≥ 3,400/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 10.0 g/dL

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 3 times ULN

          -  AST ≤ 3 times ULN

          -  Creatinine ≤ 1.5 times ULN

          -  Albumin ≥ 3 g/dL

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 1 year after
             completion of study therapy

          -  No HIV infection

          -  No other active malignancies

          -  No active uncontrolled infection

          -  No known hypersensitivity to denileukin diftitox or any of its components, including
             diphtheria toxin, aldesleukin, or excipients

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy, immunotherapy, vaccines, or radiotherapy for NHL