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Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma Clinical research trials and Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma. Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma clinical trial. Participants frequently get the best healthcare available for their Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma  Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma
Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma
For Condition: Cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of intravenous VEGF Trap in treating patients who have relapsed or refractory advanced solid tumors or non-Hodgkin's lymphoma.
Details: 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. OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients receive VEGF Trap IV over 1 hour on days 1 and 15 for a total of 2 doses. Cohorts of 3-6 patients receive escalating doses of VEGF Trap until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 6 patients are treated at that dose level. In the absence of dose-limiting toxicity, patients with stable disease or partial or complete remission may continue to receive VEGF Trap on a separate extension protocol. Patients are followed at weeks 1, 3, and 7 and then at 3 months. PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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: - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JakobDupont, Principal Investigator, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Jakob Dupont 212-639-8984
Additional Information:
Study ID Numbers: CDR0000360856; MSKCC-03137,REGENERON-VGFT-ST-0202
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083213
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Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma
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