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Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSF

19. oktober 2016 opdateret af: Sidney Kimmel Cancer Center at Thomas Jefferson University

Immuno-embolization of Hepatic Artery With Granulocyte-macrophage Colony Stimulating Factor (GM-CSF)

Patients with uveal melanoma metastatic to the liver will be treated with embolization of the hepatic artery every 4 weeks. GM-CSF (granulocyte-macrophage colony simulating factor) or normal saline will be injected into one of the liver arteries with an oily contrast dye, Ethiodol. This is followed by blockage of the artery with small pieces of gelatin sponge (embolization). It is hoped with this novel approach that:

  • tumor cells will die due to a loss of their blood supply,
  • local inflammatory reactions induced by GM-CSF will kill remaining tumor cells, and
  • a systemic immune response against tumor cells may develop.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patients with uveal melanoma metastatic to the liver will be treated with embolization of the hepatic artery every 4 weeks. GM-CSF (granulocyte-macrophage colony simulating factor) or normal saline will be injected into one of the liver arteries with an oily contrast dye, Ethiodol. This is followed by blockage of the artery with small pieces of gelatin sponge (embolization).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

53

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19317
        • Thomas Jefferson University

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Metastatic uveal melanoma in the liver with histological confirmation
  • Ability/willingness to give informed consent
  • ECOG performance status of 0 or 1
  • Adequate renal, liver and bone marrow function

Exclusion Criteria:

  • Solitary liver metastasis that is amenable to surgical removal
  • Presence of symptomatic liver failure including ascites and hepatic encephalopathy
  • Presence of extra-hepatic metastases
  • Untreated brain metastases
  • Uncontrolled hypertension or congestive heart failure or acute myocardial infarction within 6 months of entry
  • Presence of any other medical complication that imply survival of less than six months
  • Uncontrolled sever bleeding tendency or active GI bleeding
  • Significant allergic reaction to contrast dye or GM-CSF
  • Immunosuppressive treatments such as systemic steroids, radiation to pelvis or systemic chemotherapy within 4 weeks
  • Previous embolization of the hepatic artery or intrahepatic arterial chemotherapy of liver metastasis
  • Active hepatitis with serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) greater than 5 x normal
  • HIV infection positive by ELISA
  • Pregnancy or breast feeding women
  • Biliary obstruction, biliary stent or prior biliary surgery except cholecystectomy
  • Significant arteriovenous shunt identified on angiography of the hepatic artery
  • Occlusion of main portal vein or inadequate collateral flow around an occluded portal vein

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Immunoembolization
Liver embolization treatment with injection of GM-CSF.
Medicin: GM-CSF
2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.
Andre navne:
  • granulocyt-makrofag kolonistimulerende faktor
Procedure: Embolization
A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
Andre navne:
  • embo
Aktiv komparator: Plain embolization
Liver embolization with normal saline injected in place of GM-CSF
Procedure: Embolization
A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
Andre navne:
  • embo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Response of Liver Metastases
Tidsramme: Every 8 weeks

Complete response: Disappearance of all target and non-target liver lesions

Partial response: >= 30% decrease in the sum of the longest diameters (LD) relative to baseline sum LD with at least stable non-target liver lesions

Stable disease: Absence of change which would qualify as response or progression

Progression: >= 20% increase in the sum LD in target liver lesions or unequivocal progression of non-target liver lesions in the treated lobe(s) or appearance of one or more new liver lesions >= 10mm in the treated lobe(s)
Every 8 weeks
Overall Response Rate
Tidsramme: Baseline then 3 to 4 weeks after every 2 treatments
Clinical response in the liver metastases will be evaluated after every two embolizations using CT scans or MRI of the abdomen. The sum of the longest diameter (LD) of up to 6 target lesions will be used to determine response. Target indicator lesions will be identified and measured as baseline prior to the first embolization. The same target lesions will then be measured 3 to 4 weeks after every two treatments. The sum of the baseline LDs will be compared to the sum of the LDs after every two treatments.
Baseline then 3 to 4 weeks after every 2 treatments

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival
Tidsramme: Baseline to death
Measured from the start of the treatment to death of patients
Baseline to death
Median Progression Free Survival
Tidsramme: Baseline to time of progression

Measured from the start of the treatment to confirmation of progression of disease by either imaging tests or physical examination.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new liver lesions >= 10mm in the treated lobe(s).
Baseline to time of progression
Systemic Progression Free Survival
Tidsramme: Baseline to time of progression

Measured from the start of the treatment to confirmation of progression of disease by either imaging tests or physical examination.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new liver lesions >= 10mm in the treated lobe(s).
Baseline to time of progression

Samarbejdspartnere og efterforskere

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

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Takami Sato, M.D., Ph.D., Thomas Jefferson University

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. oktober 2004

Primær færdiggørelse (Faktiske)

1. december 2011

Studieafslutning (Faktiske)

1. juni 2012

Datoer for studieregistrering

Først indsendt

16. april 2008

Først indsendt, der opfyldte QC-kriterier

17. april 2008

Først opslået (Skøn)

18. april 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. november 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. oktober 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 04F.445
  • R21CA103250 (U.S. NIH-bevilling/kontrakt)

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 .

Kliniske forsøg med Levermetastaser

Kliniske forsøg med GM-CSF

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Betingelser

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