Intravenous VEGF Trap in Treating Patients With Relapsed... | NCT00082823 | Trialant
NCT00082823
Sponsor
Regeneron Pharmaceuticals
Status
Completed
Last Update Posted
Jun 3, 2016Estimated
Enrollment
25Actual
Phase
Phase 1
Conditions
Cancer
Interventions
ziv-aflibercept
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00082823
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
REGENERON-VGFT-ST-0304
Secondary IDs
ID
Type
Description
Link
MSKCC-03138
CDR0000360846
Registry Identifier
PDQ (Physician Data Query)
Brief Title
Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma
Official Title
An Open-Label, Long-Term, Safety and Tolerability Study of VEGF Trap Administered Intravenously in Patients With Advanced Solid Tumors or Lymphoma
Acronym
Not provided
Organization
Regeneron PharmaceuticalsINDUSTRY
Status Module
Record Verification Date
Jun 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 2004
Primary Completion Date
May 2008Actual
Completion Date
Not provided
First Submitted Date
May 14, 2004
First Submission Date that Met QC Criteria
May 18, 2004
First Posted Date
May 19, 2004Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 1, 2016
Last Update Posted Date
Jun 3, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Regeneron PharmaceuticalsINDUSTRY
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
RATIONALE: Intravenous VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping blood flow to the cancer.
PURPOSE: This phase I trial is studying the side effects of VEGF Trap in treating patients with relapsed or refractory advanced solid tumors or non-Hodgkin's lymphoma.
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 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.
Conditions Module
Conditions
Cancer
Keywords
recurrent grade 1 follicular lymphoma
stage IV grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
stage IV grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
stage IV grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
recurrent adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
stage IV adult diffuse mixed cell lymphoma
recurrent adult immunoblastic large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
recurrent adult Burkitt lymphoma
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
25Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ziv-aflibercept
Biological
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility 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
urethral cancer associated with invasive bladder cancer
primary peritoneal cavity cancer
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
stage IV small lymphocytic lymphoma
stage IV marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
stage IV adult soft tissue sarcoma
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Nashville
Tennessee
37232-6838
United States
Result
Wang-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.
Testicular Neoplasms
D001749
Urinary Bladder Neoplasms
D014846
Vulvar Neoplasms
D014523
Urethral Neoplasms
D018442
Lymphoma, B-Cell, Marginal Zone
D015451
Leukemia, Lymphocytic, Chronic, B-Cell
D006425
Hemic and Lymphatic Diseases
D007160
Immunoproliferative Disorders
D007154
Immune System Diseases
D016393
Lymphoma, B-Cell
D020031
Epstein-Barr Virus Infections
D006566
Herpesviridae Infections
D004266
DNA Virus Infections
D014777
Virus Diseases
D007239
Infections
D014412
Tumor Virus Infections
D007945
Leukemia, Lymphoid
D007938
Leukemia
D006402
Hematologic Diseases
D018204
Neoplasms, Connective and Soft Tissue
D000230
Adenocarcinoma
D002277
Carcinoma
D009375
Neoplasms, Glandular and Epithelial
D008113
Liver Neoplasms
D004067
Digestive System Neoplasms
D009371
Neoplasms by Site
D004066
Digestive System Diseases
D008107
Liver Diseases
D014594
Uterine Neoplasms
D005833
Genital Neoplasms, Female
D014565
Urogenital Neoplasms
D002577
Uterine Cervical Diseases
D014591
Uterine Diseases
D005831
Genital Diseases, Female
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications