Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma
Condition: Cancer
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 tumor.

      PURPOSE: This phase I trial is studying the side effects and best dose of intravenous VEGF
      Trap in treating patients with relapsed or refractory advanced solid tumors or non-Hodgkin's
      lymphoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the safety and tolerability of intravenous VEGF Trap in patients with relapsed
           or refractory advanced solid tumors or non-Hodgkin's lymphoma.

      Secondary

        -  Determine the maximum tolerated intravenous dose of this drug in these patients.

        -  Determine the pharmacokinetics of this drug in these patients.

        -  Determine the ability of this drug to bind circulating vascular endothelial growth
           factor in these patients.

        -  Determine, preliminarily, the ability of this drug to alter tumor blood flow and tumor
           vascular permeability in these patients.

        -  Determine whether antibodies to this drug develop in these patients.

      OUTLINE: This is an open-label, dose-escalation, multicenter study.

      Patients receive VEGF Trap IV over 1 hour on days 1 and 15 for a total of 2 doses.

      Cohorts of 3-6 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, an additional 6
      patients are treated at that dose level.

      In the absence of dose-limiting toxicity, patients with stable disease or partial or complete
      remission may continue to receive VEGF Trap on a separate extension protocol.

      Patients are followed at weeks 1, 3, and 7 and then at 3 months.

      PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.
    

Intervention name(s): ziv-aflibercept
Intervention type(s): Biological
Intervention MeSH terms: Aflibercept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent grade 1 follicular lymphoma; stage IV grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; stage IV grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; stage IV grade 3 follicular lymphoma; recurrent adult diffuse small cleaved cell lymphoma; stage IV adult diffuse small cleaved cell lymphoma; recurrent adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult diffuse mixed cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult immunoblastic large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; recurrent adult Burkitt lymphoma; stage IV adult Burkitt lymphoma; recurrent mantle cell lymphoma; stage IV mantle cell lymphoma; recurrent adult lymphoblastic lymphoma; stage IV adult lymphoblastic lymphoma; unspecified adult solid tumor, protocol specific; recurrent adult soft tissue sarcoma; recurrent adult primary liver cancer; advanced adult primary liver cancer; recurrent cervical cancer; stage IVA cervical cancer; stage IVB cervical cancer; fallopian tube cancer; ovarian sarcoma; recurrent ovarian epithelial cancer; stage IV ovarian epithelial cancer; recurrent endometrial carcinoma; stage IV endometrial carcinoma; recurrent uterine sarcoma; stage IV uterine sarcoma; recurrent ovarian germ cell tumor; stage IV ovarian germ cell tumor; ovarian stromal cancer; recurrent vaginal cancer; stage IVA vaginal cancer; stage IVB vaginal cancer; recurrent prostate cancer; stage IV prostate cancer; recurrent penile cancer; stage IV penile cancer; recurrent malignant testicular germ cell tumor; stage III malignant testicular germ cell tumor; recurrent bladder cancer; stage IV bladder cancer; recurrent vulvar cancer; stage IVB vulvar cancer; distal urethral cancer; proximal urethral cancer; recurrent urethral cancer; urethral cancer associated with invasive bladder cancer; primary peritoneal cavity cancer; 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; stage IV adult soft tissue sarcoma