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Trial of TG4023 Combined With Flucytosine in Liver Tumors

Information source: Transgene
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatocellular Carcinoma

Intervention: MVA-FCU1, flucytosine (Biological)

Phase: Phase 1

Status: Recruiting

Sponsored by: Transgene

Overall contact:
Jean Emmanuel Kurtz, MD, Phone: 33.388 12 84 36, Email: J-Emmanuel.KURTZ@chru-strasbourg.fr

Summary

This trial is a phase I, open-label, dose-escalating study of the safety or percutaneous intra-tumoral injection of TG4023 (MVA-FCU1) combined with systemic administration of 5-fluorocytosine in patients with primary or secondary hepatic tumors.

Clinical Details

Official title: A Phase I, Open-label, Dose-escalating Study of the Safety or Percutaneous Intra-tumoral Injection of TG4023 (MVA-FCU1) Combined With Systemic Administration of 5-fluorocytosine in Patients With Primary or Secondary Hepatic Tumors.

Study design: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maximal tolerated dose

Secondary outcome: Tumor response of injected and non-injected lesions Viral dissemination Proof of concept: 5-FU concentration in plasma and in tumors

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with advanced disease without any other standard of care treatment options:

- hepatic metastases of colorectal cancer (CRC) or of other cancers

- Hepatocellular carcinoma (HCC)

- At least one unresectable target tumor located in the liver, measuring 2-5 cm and

accessible to IT administration of TG4023 and amenable to radiological measurement using RECIST,

- Weight ≤ 100 kg,

- Patients with stable disease, who have to discontinue chemotherapy because of

intolerance,

- ECOG performance status ≤ 2,

- Life expectancy ≥ 3 months,

- Hematology:

- Absolute neutrophil count > 1,500/mm3,

- Hemoglobin > 9g/dL,

- Platelet count > 100,000/mm3,

- Prothrombin time international normalized ratio (INR) ≤ 2; partial

thromboplastin time ≤ 1. 66 times upper limit of normal (ULN),

- Biochemistry:

- Total bilirubin ≤ 3 x ULN,

- Aspartate amino-transferase (AST), alanine amino-transferase (ALT), alkaline

phosphatase

- 5. 0 x ULN,

- Creatinin clearance ≥ 40 mL/min,

- Total albumin ≥ 30 g/L,

- Anti-vitamin K anticoagulants should have been switched for low-molecular weight

heparin prior to TG4023 injection,

- Signed, written Independent Ethics Committee (IEC)-approved informed consent.

Exclusion Criteria:

- Child-Pugh stage C hepatic insufficiency,

- Impaired renal function (creatinin clearance < 40 mL/min),

- Known deficiency in dihydropyrimidine dehydrogenase (DPD) or total DPD deficiency

diagnosed at baseline in those patients not previously treated with 5-FU-related compounds,

- Ascites,

- Brain metastases,

- Significant impairment of gastro-intestinal (GI) tract absorption capacity, such as

total gastrectomy, gastric mucosal atrophy, extensive intestinal resections or malabsorption disease will not be treated by oral 5-FC,

- History of bleeding disorders,

- Pregnant or breast-feeding women,

- Human Immunodeficiency Virus (HIV) positive,

- Chronic use of immunodepressants within 4 weeks prior to TG4023 injection or

immune-depressed patients,

- Hypersensitivity to 5-FC,

- Hypersensitivity to egg proteins,

- Concomitant or previous chemotherapy or targeted therapy within 4 weeks prior to

TG4023 injection and last treatment with bevacizumab (Avastin®) within 2 months prior to TG4023 injection,

- Concomitant treatment with anti-inflammatory drugs: systemic cortico-steroids and

non-steroidal anti-inflammatory drugs (NSAIDs),

- Prior gene therapy,

- Prior participation in any other research protocol involving an IMP within 2 months

prior to TG4023 injection,

- Major surgery within 6 weeks of TG4023 injection,

Locations and Contacts

Jean Emmanuel Kurtz, MD, Phone: 33.388 12 84 36, Email: J-Emmanuel.KURTZ@chru-strasbourg.fr

Hôpitaux Civils de Colmar, Colmar 68000, France; Not yet recruiting
Fares Husseini, MD, Phone: +33.(0)389 12 41 04, Email: fares.husseini@ch-colmar.rss.fr
Fares Husseini, MD, Principal Investigator

Institut Paoli Calmette,, Marseille 13000, France; Not yet recruiting
Marc Giovannini, MD, Phone: +33.(0)491 22 37 40, Email: giovanninim@wanadoo.fr
Marc Giovannini, MD, Principal Investigator
Erwan Bories, MD, Sub-Investigator

Hôpitaux Civils de Lyon,, Pierre Benite 69495, France; Not yet recruiting
Véronique Trillet-Lenoir, MD, Phone: +33.(0)478 86 43 15, Email: veronique.trillet-lenoir@chu-lyon.fr
Cécile Fournel-Federico, MD, Sub-Investigator

Centre René Gauducheau, Saint Herblain 44800, France; Not yet recruiting
Jaafar Bennouna, MD, Phone: +33.(0)240 67 99 00, Email: j-bennouna@fnclcc.fr
Jaafar Bennouna, MD, Principal Investigator

Hôpitaux Universitaires de Strasbourg, Strasbourg 67000, France; Recruiting
J Emmanuel Kurtz, MD, Phone: +33.(0)388 12 84 36, Email: J-Emmanuel.KURTZ@chru-strasbourg.fr
J Emmanuel Kurtz, MD, Principal Investigator
Patrick Dufour, MD, Sub-Investigator

Institut Claudius Regaud, Toulouse 31000, France; Not yet recruiting
Jean-Pierre Delord, MD, Phone: +33.(0)561 42 41 14, Email: Delord.Jean-Pierre@claudiusregaud.fr
Jean-Pierre Delord, MD, Principal Investigator

Additional Information

Related publications:

Erbs P, Findeli A, Kintz J, Cordier P, Hoffmann C, Geist M, Balloul JM. Modified vaccinia virus Ankara as a vector for suicide gene therapy. Cancer Gene Ther. 2008 Jan;15(1):18-28. Epub 2007 Nov 9.

Starting date: September 2009
Last updated: September 17, 2009

Page last updated: October 04, 2010

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