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Trial of a Vaccination With Tumor Antigen-loaded Dendritic Cell-derived Exosomes

NCT01159288 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2018-03-29

No results posted yet for this study

Summary

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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

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.

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-19
Primary Completion
2015-12-19
Completion
2015-12-19

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01159288 on ClinicalTrials.gov