Vaccine Therapy With or Without Cryosurgery in Treating Patients With Residual, Relapsed, or Refractory B-Cell Non-Hodgkin Lymphoma
Condition: Cutaneous B-cell Non-Hodgkin Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Nodal Marginal Zone B-cell Lymphoma; Adult Diffuse Mixed Cell Lymphoma; Adult Diffuse Small Cleaved Cell Lymphoma; Adult Grade III Lymphomatoid Granulomatosis; Adult Immunoblastic Large Cell Lymphoma; Adult Lymphoblastic Lymphoma; Grade 1 Follicular Lymphoma; Grade 2 Follicular Lymphoma; Grade 3 Follicular Lymphoma; Mantle Cell Lymphoma; Marginal Zone Lymphoma; Small Lymphocytic Lymphoma; Splenic Marginal Zone Lymphoma; Waldenstrom Macroglobulinemia With Nodal Disease
MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone; Leukemia, Lymphocytic, Chronic, B-Cell; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large-Cell, Immunoblastic; Plasmablastic Lymphoma; Waldenstrom Macroglobulinemia; Lymphomatoid Granulomatosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      RATIONALE: Vaccines, such as dendritic cell therapy (DC) made from a person's tumor cells and
      white blood cells may help the body build an effective immune response to kill tumor cells.
      Cryosurgery kills cancer cells by freezing them. Giving vaccine therapy together with
      cryosurgery may kill more tumor cells. PURPOSE: This clinical trial studies giving vaccine
      therapy together with or without cryosurgery in treating patients with B-cell Non-Hodgkin's
      lymphoma.
    

Detailed description: 
      PRIMARY OBJECTIVES: I. Evaluation of safety and tolerability as measured by the incidence of
      significant toxicity of an autologous DC vaccine injection into a cryoablated tumor site (Arm
      A). II. Evaluation of safety and tolerability as measured by the incidence of significant
      toxicity of an autologous mature DC vaccine + tumor lysate generated in vitro and delivered
      intradermally (ID) (Arm B). SECONDARY OBJECTIVES: I. For cryoablation candidates: To assess
      feasibility, overall response rate, clinical benefit rate, time to response, and duration of
      response (Arm A). II. For patients receiving ID vaccine without cryoablation: To assess
      feasibility, clinical response rate, time to response, and duration of response (Arm B).
      TERTIARY OBJECTIVES: I. For cryoablation candidates: To assess the change over time in
      non-cryoablated nodes selected as the index lesions (Arm A). II. For patients receiving ID
      vaccine without cryoablation: To assess the change over time in measurable nodes selected as
      the index lesions (Arm B). III. To monitor patients' immune response after vaccine therapy.
      IV. Assess the immune response to Prevnar in cancer patients. V. Assess the effect of DC
      vaccination on presence of myeloid suppressors. VI. Assess the effect of tumor antigen
      delivery methods (in vivo DC into cryoablated tumor vs. ID injection of in vitro generated DC
      + lysate) on T cell response. OUTLINE: Patients are assigned to 1 of 2 treatment arms. In
      both arms, treatment continues in the absence of disease progression or unacceptable
      toxicity. After completion of study treatment, patients are followed up every 3 months for 1
      year, and then every 6 months for up to 2.5 years.
    

Intervention name(s): dendritic cell vaccine therapy; cryotherapy; pneumococcal polyvalent vaccine; laboratory biomarker analysis; immunoenzyme technique; immunohistochemistry staining method; autologous dendritic cell-tumor fusion vaccine
Intervention type(s): Biological; Procedure; Biological; Other; Other; Other; Biological
Intervention description(s): Given intratumorally; Undergo cryoablation; Given intramuscularly; Correlative studies; Correlative studies; Correlative studies; Given intradermally
Other intervention name(s): Pneumovax 23; Pnu-Imune 23; immunoenzyme techniques; immunohistochemistry
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment