Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00083213


Primary Contact:

Principal Investigator
William P. Tew, MD
Memorial Sloan Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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