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 cancer. PURPOSE: Phase I trial to study the effectiveness of VEGF Trap in patients who have relapsed or refractory solid tumors or non-Hodgkin's lymphoma.


Study summary:

OBJECTIVES: - Determine the safety and tolerability of VEGF Trap in patients with incurable relapsed or refractory solid tumors or non-Hodgkin's lymphoma. - Determine the maximum tolerated dose of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. - Evaluate the ability of this drug to bind and inactivate circulating vascular endothelial growth factor (VEGF) in these patients. - Determine the dosing regimen that is optimal for neutralization of circulating VEGF in these patients. - Determine whether antibodies to this drug develop in these patients. - Assess, preliminarily, the ability of this drug to alter tumor vascular permeability and tumor growth in these patients. OUTLINE: This is a dose-escalation study. Patients receive VEGF Trap subcutaneously once daily on days 1, 29, 36, 43, 50, 57, and 64 in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 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, 5 additional patients are treated at the MTD. Patients are followed at 1 and 4 weeks. PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed incurable primary or metastatic solid tumor or non-Hodgkin's lymphoma - Relapsed after or is refractory (e.g., unresectable) to at least 2 standard chemotherapy regimens and rituximab - No standard curative surgery, chemotherapy, immunotherapy, other antitumor therapy, or radiotherapy options exist - No known or suspected squamous cell carcinoma of the lung - No prior or concurrent CNS (brain or leptomeningeal) metastases - No prior or concurrent primary intracranial tumor by MRI or CT scan PATIENT CHARACTERISTICS: Age: - 25 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,500/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9.0 g/dL - No other severe or uncontrolled hematologic condition Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 2 times ULN - Alkaline phosphatase no greater than 2 times ULN - PT, PTT, and INR normal Renal: - Creatinine no greater than ULN - No 1+ or greater proteinuria - No other severe or uncontrolled renal condition Cardiovascular: - Electrocardiogram normal - LVEF normal by echocardiogram or MUGA scan within the past 12 months or since completion of prior anthracycline - No severe or uncontrolled cardiovascular condition - No New York Heart Association class III or IV heart disease - No active coronary artery disease, angina, congestive heart failure, or arrhythmia - No myocardial infarction within the past 6 months - No prior or concurrent peripheral vascular disease, including: - Angiographically or ultrasonographically documented arterial or venous occlusive event - Symptomatic claudication - No untreated or uncontrolled hypertension - No treated blood pressure more than 160/100 mm Hg on at least 3 repeated determinations on separate days within the past 6 weeks - No symptomatic orthostatic hypotension Pulmonary: - No severe or uncontrolled pulmonary condition - No pulmonary embolism Other: - No prior hypersensitivity reactions to any recombinant proteins (e.g., VEGF Trap) - No severe or uncontrolled gastrointestinal, immunological, or musculoskeletal condition - No severe or uncontrolled psychiatric or adverse social circumstance that would preclude study - No active infection requiring antibiotics - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective double-barrier contraception during and for at least 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - At least 3 weeks since prior immunotherapy - No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) Chemotherapy: - See Disease Characteristics - At least 3 weeks since prior chemotherapy Endocrine therapy: - No concurrent adrenal corticosteroids, except low doses as replacement therapy in patients who have previously received suppressive doses or for adrenal insufficiency - No concurrent systemic hormonal contraceptive agents Radiotherapy: - See Disease Characteristics - At least 3 weeks since prior radiotherapy Surgery: - See Disease Characteristics - At least 3 weeks since prior surgery (except fine needle biopsy/aspiration or removal/biopsy of a skin lesion) - No prior surgical procedure for correction or prophylaxis of peripheral vascular insufficiency or cerebral ischemic events Other: - Recovered from prior therapy - At least 6 months since prior treatment for acute congestive heart failure - At least 30 days since prior investigational drugs - No concurrent standard or other investigational anticancer agents - No concurrent herbal supplements ("nutraceuticals") - No concurrent anticoagulant or antiplatelet drugs, (e.g., warfarin, heparin, aspirin, or other non-steroidal anti-inflammatory drugs) except selective cyclo-oxygenase-2 (COX-2) inhibitors for analgesia - No concurrent COX-2 inhibitors for tumor treatment or prophylaxis


NCT ID:

NCT00036946


Primary Contact:

Study Chair
Jakob Dupont, 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: December 12, 2017

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