Gene Therapy of Pancreatic Ductal Adenocarcinoma

NCT01274455 | Completed Phase 1

• 1 other identifier: 0401401
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Near 85% of patients with pancreatic adenocarcinoma are diagnosed with a locally advanced and/or metastatic unresectable tumor. In these patients chemotherapy (such as gemcitabine) is given as a palliative therapy. Aim of the present study is to evaluate the feasibility, tolerance and antitumor effect of repeated intratumoral injection of a gene therapy product (with antitumor and chemo sensitizing effects) combined with gemcitabine in patients with unresectable pancreatic carcinoma.

Conditions

Pancreatic Adenocarcinoma

Keywords

Gene therapy; pancreatic carcinoma; gemcitabine; endoscopic ultrasound

Outcome Measures

Primary Outcomes (1)

• Feasability and security : Number of Participants with Adverse Events

  Feasibility, security (pancreas and general) of intratumor injections of the gene therapy product (CYL-02 plasmid DNA pre-complexed to PEI encoding sst2 dck::umk) administered under endoscopic ultrasound guidance and followed by gemcitabine treatment at standard doses.

  60 days

Secondary Outcomes (1)

• Antitumoral effect: secondary resecability, transgenes diffusion

  60 days

Study Arms (1)

Therapy

EXPERIMENTAL

Genetic: Gene Therapy product CYL-02 = plasmid DNA pre-complexed to linear polyethylenimine encoding sst2 + dck::umk genes

Interventions

Gene Therapy product CYL-02 = plasmid DNA pre-complexed to linear polyethylenimine encoding sst2 + dck::umk genes GENETIC

Intratumoral injection of the gene therapy product CYL-02 (2,5 ml within the primary tumor under endoscopic ultrasound guidance an under propofol anaesthesia). The intratumor injection of CYL-02 is followed by three IV infusions of Gemcitabine (1000 mg/m2) at 48 hours and then every two weeks. A second Intratumoral injection of the gene therapy product CYL-02 is performed at a same dosage and volume 30 days after the first administration followed by Three infusions of gemcitabine (1000 mg/m2) according the same rhythm (48 hours and every week) and dose.

Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with a pancreatic adenocarcinoma histologically proven and/or a solid pancreatic mass associated with on or multiple metastatis from pancreatic origin (histologically proven)
• Patient with a non resectable pancreatic adenocarcinoma (on preoperative CT-scan and/or endoscopic ultrasound evaluation)
• Pancreatic tumor that could be evaluated by endoscopic ultrasound (no digestive stenosis, no gastrectomy)
• Patient with no contraindication to général anaesthesia.
• Karnofsky index \>= 70%
• Written informed consent given

You may not qualify if:

• Patient unable to read or understand information/consent formula or unable to decide alone for his participation to the trial
• Patient under tutelage
• Pregnant woman or able to procreate without contraception.
• Patient with pancreatic cystic tumor or pancreatic pseudocyst.
• Patient with pancreatic tumor different from adenocarcinoma (endocrine, metastasis).
• Patient contraindication to Gemzar® :
• Hypersensitivity to Gemcitabine.
• Decision of radiotherapy
• Granulocytes \< 1000/mm3
• Thrombocytes \< 100 000/mm3
• Patient not efficiently treated for jaundice (biliary stent or bypass) if present at time of diagnosis
• Contraindication for fine needle aspiration biopsy under endoscopic ultrasound (hemostasis trouble).

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Clinical Research Center, Toulouse: collaborator
• CAYLA-INVIVOGEN: collaborator

Study Sites (1)

Toulouse Universitary Hospital (Rangueil), Department of Gastroenterology At Rangueil Hospital

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Louis BUSCAIL, MD,PhD

  University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2010
• First Posted: January 11, 2011
• Study Start: December 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 14, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)