NCT00036946

Brief Summary

RATIONALE: VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping blood flow to the cancer. PURPOSE: Phase I trial to study the effectiveness of VEGF Trap in patients who have relapsed or refractory 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

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2002

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

June 3, 2016

Status Verified

June 1, 2016

Enrollment Period

4 months

First QC Date

May 13, 2002

Last Update Submit

June 1, 2016

Conditions

LymphomaUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificstage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomarecurrent 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 lymphoma

Interventions

ziv-afliberceptBIOLOGICAL

Eligibility Criteria

Age25 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed incurable primary or metastatic solid tumor or non-Hodgkin's lymphoma * Relapsed after or is refractory (e.g., unresectable) to at least 2 standard chemotherapy regimens and rituximab * No standard curative surgery, chemotherapy, immunotherapy, other antitumor therapy, or radiotherapy options exist * No known or suspected squamous cell carcinoma of the lung * No prior or concurrent CNS (brain or leptomeningeal) metastases * No prior or concurrent primary intracranial tumor by MRI or CT scan PATIENT CHARACTERISTICS: Age: * 25 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,500/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9.0 g/dL * No other severe or uncontrolled hematologic condition Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST and ALT no greater than 2 times ULN * Alkaline phosphatase no greater than 2 times ULN * PT, PTT, and INR normal Renal: * Creatinine no greater than ULN * No 1+ or greater proteinuria * No other severe or uncontrolled renal condition Cardiovascular: * Electrocardiogram normal * LVEF normal by echocardiogram or MUGA scan within the past 12 months or since completion of prior anthracycline * No severe or uncontrolled cardiovascular condition * No New York Heart Association class III or IV heart disease * No active coronary artery disease, angina, congestive heart failure, or arrhythmia * No myocardial infarction within the past 6 months * No prior or concurrent peripheral vascular disease, including: * Angiographically or ultrasonographically documented arterial or venous occlusive event * Symptomatic claudication * No untreated or uncontrolled hypertension * No treated blood pressure more than 160/100 mm Hg on at least 3 repeated determinations on separate days within the past 6 weeks * No symptomatic orthostatic hypotension Pulmonary: * No severe or uncontrolled pulmonary condition * No pulmonary embolism Other: * No prior hypersensitivity reactions to any recombinant proteins (e.g., VEGF Trap) * No severe or uncontrolled gastrointestinal, immunological, or musculoskeletal condition * No severe or uncontrolled psychiatric or adverse social circumstance that would preclude study * No active infection requiring antibiotics * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-barrier contraception during and for at least 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * At least 3 weeks since prior immunotherapy * No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior chemotherapy Endocrine therapy: * No concurrent adrenal corticosteroids, except low doses as replacement therapy in patients who have previously received suppressive doses or for adrenal insufficiency * No concurrent systemic hormonal contraceptive agents Radiotherapy: * See Disease Characteristics * At least 3 weeks since prior radiotherapy Surgery: * See Disease Characteristics * At least 3 weeks since prior surgery (except fine needle biopsy/aspiration or removal/biopsy of a skin lesion) * No prior surgical procedure for correction or prophylaxis of peripheral vascular insufficiency or cerebral ischemic events Other: * Recovered from prior therapy * At least 6 months since prior treatment for acute congestive heart failure * At least 30 days since prior investigational drugs * No concurrent standard or other investigational anticancer agents * No concurrent herbal supplements ("nutraceuticals") * No concurrent anticoagulant or antiplatelet drugs, (e.g., warfarin, heparin, aspirin, or other non-steroidal anti-inflammatory drugs) except selective cyclo-oxygenase-2 (COX-2) inhibitors for analgesia * No concurrent COX-2 inhibitors for tumor treatment or prophylaxis

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 (3)

  • Dupont J, Schwartz L, Koutcher J, et al.: Phase I and pharmacokinetic study of VEGF Trap administered subcutaneously (sc) to patients (pts) with advanced solid malignancies. [Abstract] J Clin Oncol 22 (Suppl 14): A-3009, 197s, 2004.

    RESULT

  • Dupont J, Camastra D, Gordon MS, et al.: Phase 1 study of VEGF Trap in patients with solid tumors and lymphoma. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-776, 2003.

    RESULT

  • Tew WP, Gordon M, Murren J, Dupont J, Pezzulli S, Aghajanian C, Sabbatini P, Mendelson D, Schwartz L, Gettinger S, Psyrri A, Cedarbaum JM, Spriggs DR. Phase 1 study of aflibercept administered subcutaneously to patients with advanced solid tumors. Clin Cancer Res. 2010 Jan 1;16(1):358-66. doi: 10.1158/1078-0432.CCR-09-2103. Epub 2009 Dec 22.

    PMID: 20028764RESULT

MeSH Terms

Conditions

LymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jakob Dupont, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2002

First Posted

January 27, 2003

Study Start

November 1, 2001

Primary Completion

March 1, 2002

Last Updated

June 3, 2016

Record last verified: 2016-06

Locations

US(1)