Monoclonal Antibody Therapy in Treating Patients With Refractory Advanced Solid Tumors or Lymphoma
Condition: Lymphoma; Small Intestine Cancer; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Lymphoma; Intestinal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver
      cancer-killing substances to them without harming normal cells.

      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating
      patients who have refractory advanced solid tumors or lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose (MTD) of monoclonal antibody anti-alpha V beta 3
           integrin (MEDI 522) in patients with refractory advanced solid tumors or lymphoma.

        -  Determine the safety and tolerability of this drug in these patients.

        -  Demonstrate significant binding of this drug to its molecular target in vivo in these
           patients.

        -  Determine the effects of this drug on angiogenesis in these patients.

        -  Determine antitumor activity of this drug by measuring tumor size and glucose uptake in
           these patients.

        -  Determine the pharmacokinetics of this drug in these patients.

        -  Determine a recommended phase II dose of this drug based on either the MTD or the
           optimal biologic response in these patients.

      OUTLINE: This is a dose-escalation study.

      Patients receive monoclonal antibody anti-alpha V beta 3 integrin (Medi 522) IV over 30
      minutes weekly. Courses repeat every 4 weeks in the absence of disease progression or
      unacceptable toxicity.

      Cohorts of 6 patients receive escalating doses of Medi 522 until the maximum tolerated dose
      (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6
      patients experience dose-limiting toxicity.

      PROJECTED ACCRUAL: Approximately 6-30 patients will be accrued for this study.
    

Intervention name(s): etaracizumab
Intervention type(s): Biological
Primary purpose: Treatment
Keywords: anaplastic large cell lymphoma; angioimmunoblastic T-cell lymphoma; intraocular lymphoma; primary central nervous system lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult Burkitt lymphoma; recurrent adult Hodgkin lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent adult T-cell leukemia/lymphoma; recurrent cutaneous T-cell non-Hodgkin lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent mantle cell lymphoma; recurrent mycosis fungoides/Sezary syndrome; small intestine lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage IV adult diffuse small cleaved cell lymphoma; stage IV adult Burkitt lymphoma; stage IV adult Hodgkin lymphoma; stage IV adult immunoblastic large cell lymphoma; stage IV adult T-cell leukemia/lymphoma; stage IV cutaneous T-cell non-Hodgkin lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma; stage IV mantle cell lymphoma; stage IV mycosis fungoides/Sezary syndrome; unspecified adult solid tumor, protocol specific; stage IV adult lymphoblastic lymphoma; stage III adult diffuse large cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage III adult diffuse small cleaved cell lymphoma; stage III adult Burkitt lymphoma; stage III adult Hodgkin lymphoma; stage III adult immunoblastic large cell lymphoma; stage III adult lymphoblastic lymphoma; stage III cutaneous T-cell non-Hodgkin lymphoma; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage III mantle cell lymphoma; stage III mycosis fungoides/Sezary syndrome; stage III adult T-cell leukemia/lymphoma; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; stage III small lymphocytic lymphoma; stage III marginal zone lymphoma; stage IV small lymphocytic lymphoma; stage IV marginal zone lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma