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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 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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).

Studietyp

Interventionell

Inskrivning (Faktisk)

53

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19317
        • Thomas Jefferson University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Immunoembolization
Liver embolization treatment with injection of GM-CSF.
Läkemedel: GM-CSF
2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.
Andra namn:
  • granulocyt-makrofag kolonistimulerande faktor
Procedur: 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
Andra namn:
  • embo
Aktiv komparator: Plain embolization
Liver embolization with normal saline injected in place of GM-CSF
Procedur: 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
Andra namn:
  • embo

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Response of Liver Metastases
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Survival
Tidsram: Baseline to death
Measured from the start of the treatment to death of patients
Baseline to death
Median Progression Free Survival
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Samarbetspartners

National Cancer Institute (NCI)

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2004

Primärt slutförande (Faktisk)

1 december 2011

Avslutad studie (Faktisk)

1 juni 2012

Studieregistreringsdatum

Först inskickad

16 april 2008

Först inskickad som uppfyllde QC-kriterierna

17 april 2008

Första postat (Uppskatta)

18 april 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

29 november 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 oktober 2016

Senast verifierad

1 oktober 2016

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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