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

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.

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.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed diagnosis of one of the following:

  * Non-Hodgkin's lymphoma
  * Primary or metastatic solid tumor located, by radiography, in at least one of the following sites:

    * Liver
    * Soft tissue
    * Pelvis
    * Other site that is suitable for delayed contrast-enhanced MRI (e.g., peripheral lung field)
* Relapsed or refractory (including unresectable) disease

  * Patients with solid tumors must have failed all curative chemotherapeutic regimens
  * Patients with non-Hodgkin's lymphoma must be refractory to at least 2 standard chemotherapeutic regimens and rituximab
* Not amenable to available conventional therapies AND no standard therapy exists
* Measurable disease
* No prior or concurrent CNS metastases (brain or leptomeningeal)
* No primary intracranial tumor by MRI or CT scan
* No histologically confirmed squamous cell carcinoma of the lung

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

* WBC ≥ 3,500/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Hemoglobin ≥ 9.0 g/dL
* Platelet count ≥ 100,000/mm\^3
* No severe or uncontrolled hematologic condition

Hepatic

* Bilirubin ≤1.5 times upper limit of normal (ULN)
* AST and ALT ≤ 2.5 times ULN
* PT and PTT normal
* INR normal
* Hepatitis B surface antigen negative
* Hepatitis C antibody negative

Renal

* Creatinine ≤ ULN
* Urine protein/creatinine ratio ≤ 1
* No severe or uncontrolled renal condition

Cardiovascular

* No clinically significant acute electrocardiographic abnormalities
* LVEF normal by echocardiogram or MUGA within the past 12 months if there was prior exposure to anthracyclines
* No untreated or uncontrolled hypertension

  * No blood pressure \> 150/100 mm Hg (despite treatment)
* No isolated systolic hypertension (i.e., systolic blood pressure \> 180 mm Hg on at least 2 determinations \[on separate days\] within the past 3 months)
* No New York Heart Association class II - IV heart disease
* No active coronary artery disease requiring acute medical management
* No angina requiring acute medical management
* No congestive heart failure requiring acute medical management
* No ventricular arrhythmia requiring acute medical management
* No stroke or transient ischemic event within the past 6 months
* No prior or concurrent peripheral vascular disease

  * No angiographically or ultrasonographically documented arterial or venous occlusive event
  * No symptomatic claudication
* No symptomatic orthostatic hypotension
* No other severe or uncontrolled cardiovascular condition

Pulmonary

* No severe or uncontrolled pulmonary condition
* No pulmonary embolism within the past 6 months

Immunologic

* HIV negative
* No severe or uncontrolled immunologic condition
* No active current infection requiring antibiotics
* No prior hypersensitivity reaction to any recombinant proteins, including VEGF Trap

Other

* No severe or uncontrolled gastrointestinal or musculoskeletal condition
* No psychiatric condition or adverse social circumstance that would preclude study participation
* No other condition 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

* See Disease Characteristics
* No prior participation in a VEGF Trap, interleukin-1 Trap, or interleukin-4/13 Trap clinical trial
* At least 3 weeks since prior immunotherapy and recovered
* No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF)

Chemotherapy

* See Disease Characteristics
* At least 3 weeks since prior chemotherapy and recovered

Endocrine therapy

* No concurrent adrenal corticosteroids except low-dose replacement therapy
* No concurrent systemic hormonal contraceptive agents

Radiotherapy

* At least 3 weeks since prior radiotherapy and recovered

Surgery

* At least 3 weeks since prior major or laparoscopic surgery and recovered
* More than 6 months since prior surgical procedure for correction or prophylaxis of peripheral vascular insufficiency or cerebral ischemic events

Other

* More than 30 days since prior investigational drugs
* No concurrent anticoagulant or antiplatelet drugs (e.g., warfarin, heparin, or aspirin) other than low-dose (1 mg) warfarin for maintaining patency of venous access devices
* No concurrent non-steroidal anti-inflammatory drugs, including cyclo-oxygenase-2 (COX-2) inhibitors
* No other concurrent anticancer investigational agents
* No other concurrent anticancer therapy