Rituximab and GM-CSF in Treating Patients With Newly Diagnosed Follicular B-Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: Rituximab; Sargramostim (GM-CSF)
Intervention description: 375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22.; 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
Intervention MeSH terms: Rituximab; Molgramostim; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: contiguous stage II grade 1 follicular lymphoma; contiguous stage II grade 2 follicular lymphoma; contiguous stage II grade 3 follicular lymphoma; noncontiguous stage II grade 1 follicular lymphoma; noncontiguous stage II grade 2 follicular lymphoma; noncontiguous stage II grade 3 follicular lymphoma; stage I grade 1 follicular lymphoma; stage I grade 2 follicular lymphoma; stage I grade 3 follicular lymphoma; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma; Granulocyte-Macrophage Colony Stimulating Factor; GM-CSF; Rituximab; Rituxan

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. Colony-stimulating factors, such
      as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood.
      Giving rituximab together with GM-CSF may be an effective treatment for follicular B-cell
      lymphoma.

      PURPOSE: This phase II trial is studying the side effects and how well giving rituximab
      together with GM-CSF works in treating patients with newly diagnosed follicular B-cell
      lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have histologically confirmed newly diagnosed follicular B-cell
             lymphoma.

          2. Patients must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (longest diameter to be recorded) as >/=
             20 mm with conventional techniques or as >/= 10 mm with spiral CT scan.

          3. Patients should not have received prior therapy of any kind for follicular B-cell
             lymphoma.

          4. Age >/= 18 years. Because no dosing or adverse event data are currently available for
             the use of rituximab in combination with sargramostim in patients (males or females)
             <18 years of age, children are excluded from this study.

          5. Eastern Cooperative Oncology (ECOG) performance status </= 2 (Karnofsky >/= 60%).

          6. Patients must have normal organ and marrow function as defined below: - leukocytes >/=
             3,000/microL; - absolute neutrophil count >/= 1,500/microL; - platelets >/=
             100,000/microL; -total bilirubin within normal institutional limits; -
             AST(SGOT)/ALT(SGPT) </= 2.5 X institutional upper limit of normal; - creatinine within
             normal institutional limits OR - creatinine clearance >/= 60 mL/min/1.73 m^2 for
             patients with creatinine levels above institutional normal

          7. Hemoglobin >/= 8.0 gm/dL

          8. The effects of rituximab and sargramostim on the developing human fetus at the
             recommended therapeutic doses are unknown. For this reason women of child-bearing
             potential and men must agree to use adequate contraception (hormonal or barrier method
             of birth control; abstinence) prior to study entry and for the duration of study
             participation. Should a woman become pregnant or suspect she is pregnant while
             participating in this study, she should inform her treating physician immediately.

          9. Ability to understand and the willingness to sign an informed consent document.

        Exclusion Criteria:

          1. Prior therapy of any kind for follicular B-cell lymphoma.

          2. Patients may not be receiving any other investigational agents.

          3. Patients with known brain metastases should be excluded from this clinical trial
             because of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse events.

          4. History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to rituximab or other agents used in the study.

          5. Rituximab is contraindicated in patients with known anaphylaxis or IgE-mediated
             hypersensitivity to murine proteins. Sargramostim is contraindicated in patients with
             excessive leukemic myeloid blasts, with known hypersensitivity to GM-CSF or
             yeast-derived components of the recombinant, and for concomitant (or within 24 hours ±
             of) uses with chemotherapy or radiotherapy.

          6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          7. Pregnant women are excluded from this study.

          8. Patients with immune deficiency are at increased risk of lethal infections when
             treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving
             combination anti-retroviral therapy are excluded from the study because of possible
             pharmacokinetic interactions.

          9. Patients with evidence of active or prior infection of Hepatitis B are excluded.
             (Note: Persons vaccinated for Hepatitis B who have positive antibodies are not
             excluded).