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

An Open-Label, Long-Term, Safety and Tolerability Study of VEGF Trap Administered Intravenously in Patients With Advanced Solid Tumors or Lymphoma

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.

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.

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