NCT00045266

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 treating 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

April 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2002

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Last Updated

June 3, 2016

Status Verified

June 1, 2016

Enrollment Period

4.8 years

First QC Date

September 6, 2002

Last Update Submit

June 1, 2016

Conditions

LymphomaUnspecified Adult Solid Tumor, Protocol Specific

Keywords

recurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Burkitt lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult Burkitt lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomaunspecified adult solid tumor, protocol specificrecurrent 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 relapsed or refractory solid tumor or non-Hodgkin's lymphoma that has been treated on MSKCC-01131 * Must have completed participation in protocol MSKCC-01131 through visit 16 and have shown evidence of stable disease or complete or partial remission of tumor burden and no evidence of symptomatic deterioration * No adverse event or toxicity which resulted in discontinuation of participation in protocol MSKCC-01131 * If a patient experienced dose-limiting toxicity, then the patient must have demonstrated the ability to tolerate the same dose or a lower dose prior to entry in this study * No known or suspected squamous cell carcinoma of the lung * No prior or concurrent new neurological symptoms or CNS (brain or leptomeningeal) metastases during protocol MSKCC-01131 PATIENT CHARACTERISTICS: Age * 25 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * WBC at least 3,500/mm3 * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 9.0 g/dL * No 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 severe or uncontrolled renal condition Cardiovascular * No severe or uncontrolled cardiovascular condition Pulmonary * No severe or uncontrolled pulmonary condition 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 condition or adverse social circumstance that would preclude study * No other condition that would preclude study * 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 * No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) * No other concurrent immunotherapy Chemotherapy * No concurrent standard 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 * No concurrent radiotherapy Surgery * Not specified Other * At least 30 days since prior investigational therapy other than VEGF Trap * 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 nonsteroidal 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 (2)

  • 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, Large B-Cell, DiffuseLymphoma, Non-HodgkinBurkitt LymphomaLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, 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-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, LymphoidLeukemiaHematologic DiseasesLeukemia, 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
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 6, 2002

First Posted

January 27, 2003

Study Start

April 1, 2002

Primary Completion

February 1, 2007

Last Updated

June 3, 2016

Record last verified: 2016-06

Locations

US(1)