NCT00083213

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2004

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2004

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Last Updated

June 3, 2016

Status Verified

June 1, 2016

Enrollment Period

4.3 years

First QC Date

May 14, 2004

Last Update Submit

June 1, 2016

Conditions

Cancer

Keywords

recurrent grade 1 follicular lymphomastage IV grade 1 follicular lymphomarecurrent grade 2 follicular lymphomastage IV grade 2 follicular lymphomarecurrent grade 3 follicular lymphomastage IV grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomastage IV adult diffuse small cleaved cell lymphomarecurrent adult diffuse large cell lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomarecurrent adult Burkitt lymphomastage IV adult Burkitt lymphomarecurrent mantle cell lymphomastage IV mantle cell lymphomarecurrent adult lymphoblastic lymphomastage IV adult lymphoblastic lymphomaunspecified adult solid tumor, protocol specificrecurrent adult soft tissue sarcomarecurrent adult primary liver canceradvanced adult primary liver cancerrecurrent cervical cancerstage IVA cervical cancerstage IVB cervical cancerfallopian tube cancerovarian sarcomarecurrent ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent endometrial carcinomastage IV endometrial carcinomarecurrent uterine sarcomastage IV uterine sarcomarecurrent ovarian germ cell tumorstage IV ovarian germ cell tumorovarian stromal cancerrecurrent vaginal cancerstage IVA vaginal cancerstage IVB vaginal cancerrecurrent prostate cancerstage IV prostate cancerrecurrent penile cancerstage IV penile cancerrecurrent malignant testicular germ cell tumorstage III malignant testicular germ cell tumorrecurrent bladder cancerstage IV bladder cancerrecurrent vulvar cancerstage IVB vulvar cancerdistal urethral cancerproximal urethral cancerrecurrent urethral cancerurethral cancer associated with invasive bladder cancerprimary peritoneal cavity cancerrecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomastage IV adult soft tissue sarcoma

Interventions

ziv-afliberceptBIOLOGICAL

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan - Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (2)

  • Lockhart 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: 19949018RESULT

  • 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.

    PMID: 22002018RESULT

MeSH Terms

Conditions

NeoplasmsLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaLymphoma, Mantle-CellPrecursor Cell Lymphoblastic Leukemia-LymphomaSarcomaCarcinoma, HepatocellularUterine Cervical NeoplasmsFallopian Tube NeoplasmsCarcinoma, Ovarian EpithelialEndometrial NeoplasmsVaginal NeoplasmsProstatic NeoplasmsPenile NeoplasmsTesticular NeoplasmsUrinary Bladder NeoplasmsVulvar NeoplasmsUrethral NeoplasmsLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

aflibercept

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, LymphoidLeukemiaHematologic DiseasesNeoplasms, Connective and Soft TissueAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesFallopian Tube DiseasesAdnexal DiseasesOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersVaginal DiseasesGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital DiseasesPenile DiseasesTesticular DiseasesUrologic NeoplasmsUrinary Bladder DiseasesUrologic DiseasesVulvar DiseasesUrethral DiseasesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • William P. Tew, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2004

First Posted

May 19, 2004

Study Start

January 1, 2004

Primary Completion

May 1, 2008

Last Updated

June 3, 2016

Record last verified: 2016-06

Locations

US(1)