Clinical trial · Interventional
Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ziv-aflibercept | Biological | Aflibercept | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 therapyReferences
Publications (2)
- RESULTLockhart AC, Rothenberg ML, Dupont J, Cooper W, Chevalier P, Sternas L, Buzenet G, Koehler E, Sosman JA, Schwartz LH, Gultekin DH, Koutcher JA, Donnelly EF, Andal R, Dancy I, Spriggs DR, Tew WP. Phase I study of intravenous vascular endothelial growth factor trap, aflibercept, in patients with advanced solid tumors. J Clin Oncol. 2010 Jan 10;28(2):207-14. doi: 10.1200/JCO.2009.22.9237. Epub 2009 Nov 30. PMID 19949018
- RESULTWang-Gillam A, Tew WP, Rothenberg ML, Dupont J, Cooper W, Sternas L, Buzenet G, Sosman JA, Spriggs DR, Lockhart AC. A phase I study of subcutaneously administered aflibercept (VEGF trap) in a new formulation in patients with advanced solid tumors. Invest New Drugs. 2012 Oct;30(5):1958-61. doi: 10.1007/s10637-011-9753-y. Epub 2011 Oct 15. PMID 22002018