Status:
COMPLETED
Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
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 intra...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00083213
Start Date
January 1 2004
Last Update
June 3 2016
Active Locations (1)
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1
Memorial Sloan - Kettering Cancer Center
New York, New York, United States, 10021