Clinical trial · Interventional
VEGF Trap in Treating Patients With Relapsed or Refractory Solid Tumors or Non-Hodgkin's Lymphoma
An Open-Label, Sequential Cohort Dose-Escalation Safety, Tolerability And Pharmacokinetic Study Of VEGF Trap In Patients With Incurable, Relapsed Or Refractory 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 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ziv-aflibercept | Biological | Aflibercept | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 prophylaxisReferences
Publications (4)
- RESULTDupont J, Schwartz L, Koutcher J, et al.: Phase I and pharmacokinetic study of VEGF Trap administered subcutaneously (sc) to patients (pts) with advanced solid malignancies. [Abstract] J Clin Oncol 22 (Suppl 14): A-3009, 197s, 2004.
- RESULTDupont J, Camastra D, Gordon MS, et al.: Phase 1 study of VEGF Trap in patients with solid tumors and lymphoma. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-776, 2003.
- RESULTTew WP, Gordon M, Murren J, Dupont J, Pezzulli S, Aghajanian C, Sabbatini P, Mendelson D, Schwartz L, Gettinger S, Psyrri A, Cedarbaum JM, Spriggs DR. Phase 1 study of aflibercept administered subcutaneously to patients with advanced solid tumors. Clin Cancer Res. 2010 Jan 1;16(1):358-66. doi: 10.1158/1078-0432.CCR-09-2103. Epub 2009 Dec 22. PMID 20028764
- DERIVEDWazan LE, Widhibrata A, Liu GS. Soluble FLT-1 in angiogenesis: pathophysiological roles and therapeutic implications. Angiogenesis. 2024 Nov;27(4):641-661. doi: 10.1007/s10456-024-09942-8. Epub 2024 Aug 29. PMID 39207600