An Open-Label, Long-Term, Safety and Tolerability Study of VEGF Trap Administered Intravenously in Patients With Advanced Solid Tumors or Lymphoma
Data Collection
Immune System Diseases+4
+ Immunoproliferative Disorders
+ Lymphatic Diseases
Treatment Study
Summary
Study start date: January 1, 2004
Actual date on which the first participant was enrolled.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 steady-state pharmacokinetics of this drug in these patients. * Determine the ability of this drug to bind circulating vascular endothelial growth factor in these patients. * Determine whether antibodies to this drug develop in these patients. * Determine, preliminarily, the ability of repeated doses of this drug to alter tumor growth and vascular permeability in these patients. OUTLINE: This is an open-label, multicenter, extension study. Patients receive VEGF Trap\* IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. NOTE: \*Patients receive the same drug dose that they received in MSKCC-03137 (VGFT-ST-0202) Patients are followed monthly for 3 months. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 3-6 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: * Histologically confirmed non-Hodgkin's lymphoma OR primary or metastatic solid tumor located in at least one of the following sites: * Liver * Soft tissue * Pelvis * Other site that is suitable for delayed contrast-enhancing MRI * Relapsed or refractory disease * Failed all conventional therapeutic options AND not amenable to existing therapeutic options * Must have completed the active phase (through study visit 9) of MSKCC-03137 (VGFT-ST-0202) without experiencing dose-limiting toxicity * No prior or concurrent CNS metastases (brain or leptomeningeal) * No new neurological symptoms during treatment on MSKCC-03137 (VGFT-ST-0202) PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * No severe or uncontrolled hematologic condition Hepatic * Not specified Renal * No severe or uncontrolled renal condition Cardiovascular * No severe or uncontrolled cardiovascular condition Pulmonary * No severe or uncontrolled pulmonary condition Other * No severe or uncontrolled gastrointestinal, immunologic, or musculoskeletal condition * No other medical or psychiatric condition or adverse social circumstance 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 * No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) Chemotherapy * Not specified Endocrine therapy * No concurrent adrenal corticosteroids, except low-dose replacement therapy * No concurrent systemic hormonal contraceptive agents Radiotherapy * Not specified Surgery * Not specified Other * No concurrent non-steroidal anti-inflammatory drugs, including cyclo-oxygenase-2 (COX-2) inhibitors * No concurrent anticoagulant or antiplatelet drugs, including warfarin, heparin, or aspirin * Concurrent low-dose (i.e., 1 mg) warfarin for maintaining patency of venous access devices allowed * No other concurrent standard or investigational agents for this malignancy
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Vanderbilt-Ingram Cancer Center
Nashville, United States