An Open Label, Sequential Cohort Dose-Escalation Safety, Tolerability and Pharmacokinetic Study of VEGF Trap Administered Intravenously in Patients With Advanced Solid Tumors or Lymphoma

Date de début de l'étude : 1 janvier 2004

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