NCT00082823

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.

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

2 active sites

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 lymphomarecurrent adult diffuse mixed cell lymphomastage IV 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 sarcomaadvanced adult primary liver cancerrecurrent 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 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

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

Sponsors & Collaborators

Study Sites (2)

Memorial Sloan - Kettering Cancer Center

New York, New York, 10021, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, 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(2)