Monoclonal Antibody Therapy in Treating Patients With Lymphoma or Colon Cancer That Has Not Responded to Vaccine Therapy
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Monoclonal antibodies such as anti-cytotoxic T-lymphocyte-associated antigen-4 can
      locate cancer cells and either kill them or deliver cancer-killing substances to them without
      harming normal cells.

      PURPOSE: This phase II trial is studying anti-cytotoxic T-lymphocyte-associated antigen-4
      monoclonal antibody to see how well it works in treating patients with lymphoma or colon
      cancer that has not responded to vaccine therapy.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the toxicity of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal
           antibody in patients with follicular or mantle cell lymphoma, colon cancer, or prostate
           cancer refractory to vaccine therapy. (part I) (prostate cancer and mantle cell lymphoma
           closed to accrual as of 3/10/2005; colon cancer closed to accrual as of 9/28/05)

        -  Determine the toxicity of this drug at escalating doses in patients with follicular
           lymphoma. (part II)

        -  Determine the toxicity of this drug at escalating doses in patients with non-Hodgkin's
           lymphoma or Hodgkin's lymphoma. (part III)

      Secondary

        -  Determine the ability of this drug to increase tumor-specific T-cell responses in these
           patients.

        -  Determine the ability of this drug to produce clinical tumor response in these patients.

        -  Determine the effect of this drug on suppressor T-cell populations (CD4+ and CD25+
           cells) in these patients.

      OUTLINE: This is a pilot, partial dose-escalation study.

        -  Part I (patients with prostate or colon cancer or follicular or mantle cell lymphomas)
           (prostate cancer and mantle cell lymphoma closed to accrual as of 3/10/2005; colon
           cancer closed to accrual as of 9/28/05): Patients receive anti-cytotoxic
           T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4) IV over 90 minutes on
           day 1. Treatment repeats every 28 days for 4 courses in the absence of disease
           progression or unacceptable toxicity.

        -  Part II (dose-escalation) (patients with follicular lymphomas only): Patients receive
           MDX-CTLA4 as in part I. Treatment repeats every 21 days for up to 6 courses in the
           absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of MDX-CTLA4 until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
      patients experience dose-limiting toxicity.

        -  Part III (dose-escalation*) (patients with non-Hodgkin's or Hodgkin's lymphoma):
           Patients receive MDX-CTLA4 as in part II.

      NOTE: No dose-escalation for lymphoma patients who have previously been treated with an
      allogeneic stem cell transplantation.

      Patients are followed every other month.

      PROJECTED ACCRUAL: A total of 89 patients will be accrued for this study.
    

Intervention name(s): ipilimumab
Intervention type(s): Biological
Intervention MeSH terms: Ipilimumab
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; contiguous stage II adult lymphoblastic lymphoma; noncontiguous stage II adult lymphoblastic lymphoma; recurrent adult lymphoblastic lymphoma; stage I adult lymphoblastic lymphoma; stage III adult lymphoblastic lymphoma; stage IV adult lymphoblastic lymphoma; noncontiguous stage II grade 3 follicular lymphoma; recurrent grade 3 follicular lymphoma; stage I grade 3 follicular lymphoma; stage III grade 3 follicular lymphoma; stage IV grade 3 follicular lymphoma; contiguous stage II grade 3 follicular lymphoma; contiguous stage II grade 2 follicular lymphoma; contiguous stage II grade 1 follicular lymphoma; contiguous stage II adult diffuse mixed cell lymphoma; noncontiguous stage II adult diffuse mixed cell lymphoma; recurrent adult diffuse mixed cell lymphoma; stage I adult diffuse mixed cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage IV adult diffuse mixed cell lymphoma; contiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; recurrent adult diffuse large cell lymphoma; stage I adult diffuse large cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma; contiguous stage II adult immunoblastic large cell lymphoma; noncontiguous stage II adult immunoblastic large cell lymphoma; recurrent adult immunoblastic large cell lymphoma; stage I adult immunoblastic large cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; contiguous stage II adult Burkitt lymphoma; noncontiguous stage II adult Burkitt lymphoma; recurrent adult Burkitt lymphoma; stage I adult Burkitt lymphoma; stage III adult Burkitt lymphoma; stage IV adult Burkitt lymphoma; contiguous stage II mantle cell lymphoma; noncontiguous stage II mantle cell lymphoma; recurrent mantle cell lymphoma; stage I mantle cell lymphoma; stage III mantle cell lymphoma; stage IV mantle cell lymphoma; recurrent adult Hodgkin lymphoma; stage I adult Hodgkin lymphoma; stage II adult Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; recurrent adult diffuse small cleaved cell lymphoma; stage I adult diffuse small cleaved cell lymphoma; stage II adult diffuse small cleaved cell lymphoma; stage III adult diffuse small cleaved cell lymphoma; stage IV adult diffuse small cleaved cell lymphoma; contiguous stage II marginal zone lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; noncontiguous stage II marginal zone lymphoma; recurrent marginal zone lymphoma; splenic marginal zone lymphoma; stage I marginal zone lymphoma; stage III marginal zone lymphoma; stage IV marginal zone lymphoma; contiguous stage II small lymphocytic lymphoma; noncontiguous stage II small lymphocytic lymphoma; recurrent small lymphocytic lymphoma; stage I small lymphocytic lymphoma; stage III small lymphocytic lymphoma; stage IV small lymphocytic lymphoma; recurrent adult T-cell leukemia/lymphoma; recurrent cutaneous T-cell non-Hodgkin lymphoma; stage I adult T-cell leukemia/lymphoma; stage I cutaneous T-cell non-Hodgkin lymphoma; stage II adult T-cell leukemia/lymphoma; stage II cutaneous T-cell non-Hodgkin lymphoma; stage III adult T-cell leukemia/lymphoma; stage III cutaneous T-cell non-Hodgkin lymphoma; stage IV adult T-cell leukemia/lymphoma; stage IV cutaneous T-cell non-Hodgkin lymphoma