NCT00083213CompletedPhase 1
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
Regeneron Pharmaceuticals1 site in 1 country25 target enrollmentStarted: January 1, 2004Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 25
- Locations
- 1
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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:
- •Soft tissue
- •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:
- •18 and over
- •Performance status
- •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
- •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
- •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
- +35 more not shown
Exclusion Criteria
- Not provided
Investigators
Study Sites (1)
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