Trial of a Vaccination With Tumor Antigen-loaded Dendritic Cell-derived Exosomes (CSET 1437)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2010 by Gustave Roussy, Cancer Campus, Grand Paris
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT01159288
First received: July 8, 2010
Last updated: April 3, 2012
Last verified: July 2010

July 8, 2010
April 3, 2012
December 2009
December 2014   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01159288 on ClinicalTrials.gov Archive Site
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Trial of a Vaccination With Tumor Antigen-loaded Dendritic Cell-derived Exosomes
Phase II Trial of a Vaccination With Tumor Antigen-loaded Dendritic Cell-derived Exosomes on Patients With Unresectable Non Small Cell Lung Cancer Responding to Induction Chemotherapy

Lung cancer is the worldwide leading cause of cancer death. In France, with 28,000 new cases per year, lung cancer is the 4th in terms of incidence but remains the leading cause of cancer death. The 5-year survival of lung cancer, all stages and all types, is very low, estimated at 12% among men and 16% among women in France. In advanced unresectable non small cell lung cancer, standard treatment relies on platinum-based induction chemotherapy. The median progression-free survival (PFS) in patients responding or stabilized after 4 chemotherapy cycles ranges from 2 to 2.8 months. Gustave Roussy and Curie institutes have developed an immunotherapy involving metronomic cyclophosphamide (mCTX) followed by vaccinations with tumor antigen-loaded dendritic cell-derived exosomes (Dex). mCTX inhibits Treg functions restoring T and NK cell effector functions and Dex are able to activate the innate and adaptive immunity. Phase I trials showed the safety and feasibility of Dex vaccines but no induction of T cells could be monitored in patients. Since 2007, we validated a new process for isolation of second generation Dex with improved immune stimulatory capacities. We propose a maintenance immunotherapy in 47 advanced unresectable NSCLC patients responding or stabilized after induction chemotherapy with Dex-based treatment to improve PFS rate at 4 months in these patients.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non Small Cell Lung Cancer
Biological: Dex2
  • Metronomic dosage of Cyclophosphamide during 3 weeks (50mg/day orally) as reported 15, before specific treatment.
  • Induction immunotherapyIntradermal injections of Dex once a week during 4 consecutive weeks.(Peptides pulsed onto DC, sources of Dex: PRS pan-DR, MAGE-3 DP04, MAGE-1 A2, MAGE-3 A2, NY-ESO-1 A2 et MART-1 A2)
  • Continuation Immunotherapy: Intradermal injections of Dex every two weeks during 6 weeks.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
47
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • advanced unresectable non small cell lung cancer
  • responding or stabilizer after induction chemotherapy
Both
18 Years to 70 Years
No
Contact: Benjamin BESSE, MD 33 1 42114322 benjamin.besse@igr.fr
Contact: Nathalie CHAPUT, MD 33 1 42115005 nathalie.chaput@igr.fr
France
 
NCT01159288
IGR Dex2
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Gustave Roussy, Cancer Campus, Grand Paris
Gustave Roussy, Cancer Campus, Grand Paris
Not Provided
Not Provided
Gustave Roussy, Cancer Campus, Grand Paris
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP