VEGF Trap in Treating Patients With Relapsed or Refractory Solid Tumors or Non-Hodgkin's Lymphoma
Condition: Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by
      stopping blood flow to the cancer.

      PURPOSE: Phase I trial to study the effectiveness of VEGF Trap in patients who have relapsed
      or refractory solid tumors or non-Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the safety and tolerability of VEGF Trap in patients with incurable relapsed
           or refractory solid tumors or non-Hodgkin's lymphoma.

        -  Determine the maximum tolerated dose of this drug in these patients.

        -  Determine the pharmacokinetics of this drug in these patients.

        -  Evaluate the ability of this drug to bind and inactivate circulating vascular
           endothelial growth factor (VEGF) in these patients.

        -  Determine the dosing regimen that is optimal for neutralization of circulating VEGF in
           these patients.

        -  Determine whether antibodies to this drug develop in these patients.

        -  Assess, preliminarily, the ability of this drug to alter tumor vascular permeability and
           tumor growth in these patients.

      OUTLINE: This is a dose-escalation study.

      Patients receive VEGF Trap subcutaneously once daily on days 1, 29, 36, 43, 50, 57, and 64 in
      the absence of disease progression or unacceptable toxicity.

      Cohorts of 1-6 patients receive escalating doses of VEGF Trap 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. Once the MTD is determined, 5 additional patients
      are treated at the MTD.

      Patients are followed at 1 and 4 weeks.

      PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.
    

Intervention name(s): ziv-aflibercept
Intervention type(s): Biological
Intervention MeSH terms: Aflibercept
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma; stage IV adult diffuse small cleaved cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; stage IV adult lymphoblastic lymphoma; stage IV adult Burkitt lymphoma; 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; stage IV mantle cell lymphoma; recurrent mantle cell lymphoma; recurrent marginal zone lymphoma; recurrent small lymphocytic 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