GM-CSF and Rituximab After Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Follicular Non-Hodgkin Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: filgrastim; rituximab; sargramostim; carmustine; cytarabine; etoposide; melphalan; autologous hematopoietic stem cell transplantation
Intervention MeSH terms: Cytarabine; Rituximab; Etoposide; Melphalan; Carmustine; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma

Summary:

      RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant helps stop
      the growth of cancer cells by stopping them from dividing or by killing them. An autologous
      stem cell transplant may be able to replace the blood-forming cells that were destroyed by
      chemotherapy. GM-CSF may increase the number of immune cells found in bone marrow or
      peripheral blood. Giving a monoclonal antibody, such as rituximab, after the transplant may
      find any remaining cancer cells and either kill them or deliver cancer-killing substances to
      them without harming normal cells. Giving GM-CSF together with rituximab after autologous
      stem cell transplant may be an effective treatment for follicular non-Hodgkin lymphoma.

      PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab after
      autologous stem cell transplant works in treating patients with relapsed or primary
      refractory follicular non-Hodgkin lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologic diagnosis of grade 1, 2, 3, or transformed follicular lymphoma

          -  Achieved a complete or partial response to last salvage therapy

               -  Completed salvage therapy within the past 12 weeks

               -  No disease progression since last salvage therapy

          -  One of the following disease statuses must have been present prior to receiving
             salvage therapy

               -  Refractory to last anti-lymphoma therapy

               -  Last remission duration less than 1½ years if salvage therapy is 3rd regimen

               -  Last remission duration less than 3 years if salvage therapy is 2nd regimen

          -  Minimum of 2 x 10^6 CD34+ cells/kg cryopreserved and available for hematopoietic stem
             cell support

          -  No leptomeningeal disease or brain parenchyma involvement

        PATIENT CHARACTERISTICS:

          -  Cardiac ejection fraction > 50%

               -  If over 60 years of age, no evidence of cardiac ischemia by treadmill stress test
                  (stress echo or sesta-MIBI)

          -  Adjusted diffusing capacity ≥ 50% of the predicted value on pulmonary function testing

          -  Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 50 mL/min

          -  ANC > 1,000/μL

          -  Platelet count > 50,000/μL

          -  Total bilirubin ≤ 2.0 mg/dL (≤ 3.0 mg/dL if Gilbert's disease is suspected)

          -  Not pregnant or breast-feeding

          -  Fertile patients must use an acceptable form of birth control

          -  HIV I or II negative

          -  No acute or chronic hepatitis B

          -  No active hepatitis C

          -  No medical illness (unrelated to non-Hodgkin lymphoma), including malignancies that,
             in the opinion of the attending physician and/or principal investigator, would
             preclude study treatment

          -  No other malignancy within the past 5 years except curatively treated cutaneous basal
             cell or squamous cell carcinoma or carcinoma in situ of the cervix

        PRIOR CONCURRENT THERAPY:

          -  No more than 3 prior anti-lymphoma regimens, inclusive of the salvage therapy

               -  Biologic agents (e.g., monoclonal antibodies and vaccines) administered as part
                  of a planned treatment regimen will not be considered distinct regimens

               -  Chemotherapy administered primarily for the purpose of stem cell mobilization
                  (e.g., cyclophosphamide at 2-4 g/m²) will not be considered an anti-lymphoma
                  regimen

          -  No prior autologous or allogeneic hematopoietic stem cell transplantation