Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Condition: Leukemia; Lymphoma
MeSH terms: Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: bispecific antibody 4G7xH22; sargramostim
Intervention MeSH terms: Antibodies; Sargramostim; Antibodies, Bispecific
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: refractory chronic lymphocytic leukemia; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent adult Burkitt lymphoma; recurrent mantle cell lymphoma; recurrent small lymphocytic lymphoma

Summary:

      RATIONALE: Antibodies can locate tumor cells and either kill them or deliver tumor-killing
      substances to them without harming normal cells.

      PURPOSE: Phase I trial to study the effectiveness of antibody therapy in treating patients
      who have refractory or relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of CD19+ non-Hodgkin's lymphoma or chronic lymphocytic leukemia

               -  Primary refractory or multiply relapsed (after at least 2 prior chemotherapy
                  regimens) disease

               -  Ineligible for bone marrow or peripheral blood stem cell transplantation

        PATIENT CHARACTERISTICS:

        Age:

          -  Over 18

        Performance status:

          -  ECOG 0-2

        Life expectancy:

          -  More than 3 months

        Hematopoietic:

          -  WBC greater than 3,000/mm^3

          -  Platelet count greater than 100,000/mm^3

          -  Absolute neutrophil count greater than 1,500/mm^3

        Hepatic:

          -  Bilirubin less than 1.5 mg/dL

          -  Alkaline phosphatase less than 2 times normal

          -  SGPT less than 2 times normal

        Renal:

          -  Creatinine clearance greater than 50 mL/min

        Other:

          -  No human-anti-murine-antibody response to prior murine monoclonal antibodies

          -  No immunological or inflammatory disease (e.g., lupus erythematosus)

          -  No active serious infection

          -  No other serious medical condition that would limit survival to less than 2 years

          -  No other active malignancy except non-melanoma skin cancer or carcinoma in situ of the
             cervix

          -  No psychiatric or addictive disorder that would preclude study

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Prior immunotherapy allowed

        Chemotherapy:

          -  See Disease Characteristics

          -  No concurrent chemotherapy

        Endocrine therapy:

          -  Concurrent steroids for adrenal failure or adverse reactions to study drug allowed

          -  Concurrent hormonal therapy for non-disease related conditions (e.g., insulin for
             diabetes) allowed

        Radiotherapy:

          -  Not specified

        Surgery:

          -  Not specified