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Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma

1. juni 2016 opdateret af: Regeneron Pharmaceuticals

An Open Label, Sequential Cohort Dose-Escalation Safety, Tolerability and Pharmacokinetic Study of VEGF Trap Administered Intravenously in Patients With Advanced Solid Tumors or Lymphoma

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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 maximum tolerated intravenous dose of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.
  • Determine the ability of this drug to bind circulating vascular endothelial growth factor in these patients.
  • Determine, preliminarily, the ability of this drug to alter tumor blood flow and tumor vascular permeability in these patients.
  • Determine whether antibodies to this drug develop in these patients.

OUTLINE: This is an open-label, dose-escalation, multicenter study.

Patients receive VEGF Trap IV over 1 hour on days 1 and 15 for a total of 2 doses.

Cohorts of 3-6 patients receive escalating doses of VEGF Trap until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 6 patients are treated at that dose level.

In the absence of dose-limiting toxicity, patients with stable disease or partial or complete remission may continue to receive VEGF Trap on a separate extension protocol.

Patients are followed at weeks 1, 3, and 7 and then at 3 months.

PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

25

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • New York
      • New York, New York, Forenede Stater, 10021
        • Memorial Sloan - Kettering Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 120 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: William P. Tew, MD, Memorial Sloan Kettering Cancer Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2004

Primær færdiggørelse (Faktiske)

1. maj 2008

Datoer for studieregistrering

Først indsendt

14. maj 2004

Først indsendt, der opfyldte QC-kriterier

18. maj 2004

Først opslået (Skøn)

19. maj 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. juni 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2016

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • REGENERON-VGFT-ST-0202
  • MSKCC-03137
  • CDR0000360856 (Registry Identifier: PDQ (Physician Data Query))

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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