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188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas (LIP-RE-I)

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ClinicalTrials.gov Identifier: NCT01126463
Recruitment Status : Recruiting
First Posted : May 19, 2010
Last Update Posted : January 31, 2019
Sponsor:
Collaborators:
Rennes University Hospital
Ecole Nationale Superieure de Chimie de Rennes
Information provided by (Responsible Party):
Center Eugene Marquis

Brief Summary:
This study is to determine the maximum tolerated dose and the recommended 188Re-SSS Lipiodol activity for hepatic intra-arterial injection in patients with hepato-cellular carcinoma. The new radioactive isotope 188Rhenium associated with Lipiodol is expected to reduce the radioprotection constraints and hence the duration of the hospitalisation in a protected room from 8 to 1 day.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinomas Drug: 188Re-SSS Lipiodol Phase 1

Detailed Description:

Hepatocellular carcinoma is one of the most prevalent primary cancers in many countries. In France, mortality due to HCC on viral C cirrhosis is going to increase of about 150% for men and 200% for women until 2020. Consequently, HCC is a problem of public health.

The current treatment for HCC is mainly palliative with chemoembolization or intra-arterial radiotherapy, and intra-arterial targeted radiotherapy being the best tolerated method (iodine-131-labelled lipiodol being the most commonly used).

However, since 2007, a new therapeutic approach can be considered with oral sorafenib, an anti-angiogenic drug which increases slightly the survival of patients.

The key for an efficient treatment of HCC is presumably a co-treatment of sorafenib and intra-arterial radiotherapy. The 131I-lipiodol is a good candidate but presents disadvantages: it requires hospitalization in a radionuclide therapy room for one week. Therefore, it is necessary to find new radioactive labellings for lipiodol. In this objective, 188Re-SSS lipiodol, a new radioactive labeled stable complex has been developed. It has a short half-life and a tiny amount of gamma radiation compared to 131I-lipiodol, so it allows to reduce hospitalization in a protected room from 8 days to only one day.

The aim of this study is to determine the Maximum Tolerated Dose and thus the recommended activity of 188Re-SSS lipiodol by intra-arterial injection in patients with HCC.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Hepatic Intra-Arterial Administration of 188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas
Study Start Date : May 2010
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rhenium Lipiodol
Hepatic Intra-Arterial Administration of radio-active lipiodol.
Drug: 188Re-SSS Lipiodol
Hepatic Intra-Arterial Administration of radio-active lipiodol.




Primary Outcome Measures :
  1. Maximal tolerated dose [ Time Frame: Injection each week during 4 weeks and at month 2 ]
    Toxicity CTC grade ≥ 3 with CTCAE version 4.


Secondary Outcome Measures :
  1. Bio-availability [ Time Frame: 1, 6, 24 et 48 hours after treatment injection ]
    Measurement by gamma-scintigraphy and by measurement of radio-activity in urinary, faecal and blood samples.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult over 18,
  • WHO performance status ≤ 2,
  • Hepatocellular carcinoma histologically or cytologically proven, or association of liver tumor with chronic hepatopathy and AFP > 400 ng/ml, or tumorous hepatic formation considered as hypervascularised by at least 2 methods of imaging in cirrhotic patient, Non operable, non resectable, non transplantable, non accessible to percutaneous treatment tumor,
  • Measurable tumor, uni- or multinodular, taking up less than 50% of hepatic volume,
  • Stage A to C of the BCLC classification (or stage 0 to 4 of the CLIP) with:

    • No thrombosis of the portal vein, therapeutic escape or intolerance causing the end of the treatment or contraindication to sorafenib
    • If thrombosis of the portal vein, therapeutic escape to Lipiocis,
  • Possibility of treatment by intra-arterial radiotherapy over a decision of a Multidisciplinary Committee,
  • Written informed consent

Exclusion Criteria:

  • Patient with a stage ≥ 3 toxicity of the CTCAE version 4
  • Stage D of the classification BCLC
  • Acute impairment of hepatic functions (Child-Pugh B9 or C)
  • Grade III Hepatocarcinoma of the Okuda classification
  • Encephalopathy with troubles even moderated of cognitive functions
  • Advanced chronic respiratory insufficiency
  • Creatinine clearance < 55 ml/min, polynuclear neutrophils < 1500 G/L, platelets < 50 G/L, prothrombin < 40% (INR > 2,3)
  • Contraindication to the intra-arterial administration
  • Patients who can't be followed up for psychological or geographic reasons
  • Patients dependant on another person for daily care
  • Urinary incontinence
  • Progressive cancer
  • Pregnant or breastfeeding woman, or not using adequate effective contraception method

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01126463


Contacts
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Contact: Oussama ZEKRI, PhD +33/299253132 o.zekri@rennes.fnclcc.fr

Locations
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France
Centre Eugene Marquis Recruiting
Rennes, France, 35000
Contact: Etienne GARIN, MD, PhD    +33/299253088    e.garin@rennes.fnclcc.fr   
Principal Investigator: Etienne GARIN, MD, PhD         
Sponsors and Collaborators
Center Eugene Marquis
Rennes University Hospital
Ecole Nationale Superieure de Chimie de Rennes
Investigators
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Principal Investigator: Etienne GARIN, MD, PhD Centre Eugene Marquis

Publications:
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Responsible Party: Center Eugene Marquis
ClinicalTrials.gov Identifier: NCT01126463     History of Changes
Other Study ID Numbers: LIP-RE-I
First Posted: May 19, 2010    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019

Keywords provided by Center Eugene Marquis:
Hepatocellular carcinomas
lipiodol
rhenium
Non operable Hepatocellular carcinomas

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Ethiodized Oil
Antineoplastic Agents