Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma

Summary: RATIONALE: Intravenous VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping blood flow to the cancer.
  PURPOSE: This phase I trial is studying the side effects of 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 steady-state pharmacokinetics of this drug in these patients.
  -  Determine the ability of this drug to bind circulating vascular endothelial growth factor in these patients.
  -  Determine whether antibodies to this drug develop in these patients.
  -  Determine, preliminarily, the ability of repeated doses of this drug to alter tumor growth and vascular permeability in these patients.
  OUTLINE: This is an open-label, multicenter, extension study.
  Patients receive VEGF Trap* IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
  NOTE: *Patients receive the same drug dose that they received in MSKCC-03137 (VGFT-ST-0202)
  Patients are followed monthly for 3 months.
  PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 3-6 months.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed non-Hodgkin's lymphoma OR primary or metastatic solid tumor located in at least one of the following sites:
  -  Liver
  -  Soft tissue
  -  Pelvis
  -  Other site that is suitable for delayed contrast-enhancing MRI
  -  Relapsed or refractory disease
  -  Failed all conventional therapeutic options AND not amenable to existing therapeutic options
  -  Must have completed the active phase (through study visit 9) of MSKCC-03137 (VGFT-ST-0202) without experiencing dose-limiting toxicity
  -  No prior or concurrent CNS metastases (brain or leptomeningeal)
  -  No new neurological symptoms during treatment on MSKCC-03137 (VGFT-ST-0202)
  PATIENT CHARACTERISTICS:
  Age
  -  18 and over
  Performance status
  -  Not specified
  Life expectancy
  -  Not specified
  Hematopoietic
  -  No severe or uncontrolled hematologic condition
  Hepatic
  -  Not specified
  Renal
  -  No severe or uncontrolled renal condition
  Cardiovascular
  -  No severe or uncontrolled cardiovascular condition
  Pulmonary
  -  No severe or uncontrolled pulmonary condition
  Other
  -  No severe or uncontrolled gastrointestinal, immunologic, or musculoskeletal condition
  -  No other medical or psychiatric condition or adverse social circumstance that would preclude study participation
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective double-barrier contraception during and for 3 months after study treatment
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF)
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  No concurrent adrenal corticosteroids, except low-dose replacement therapy
  -  No concurrent systemic hormonal contraceptive agents
  Radiotherapy
  -  Not specified
  Surgery
  -  Not specified
  Other
  -  No concurrent non-steroidal anti-inflammatory drugs, including cyclo-oxygenase-2 (COX-2) inhibitors
  -  No concurrent anticoagulant or antiplatelet drugs, including warfarin, heparin, or aspirin
  -  Concurrent low-dose (i.e., 1 mg) warfarin for maintaining patency of venous access devices allowed
  -  No other concurrent standard or investigational agents for this malignancy

Relevance to patient case: not relevant