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Randomized Phase 2 With CpG-ODN in Malignant Glioblastoma

This study has been completed.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris Identifier:
First received: September 14, 2005
Last updated: December 12, 2012
Last verified: September 2005
The purpose of this study is to determine whether the immunostimulating agent CpG-ODN is effective in the treatment of glioblastoma

Condition Intervention Phase
Drug: CpG-ODN
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Multicentric Randomized Phase 2. Immunotherapy With CpG-ODN in Malignant Glioblastoma

Resource links provided by NLM:

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Survival [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 2 years ]
  • Tolerance [ Time Frame: 2 years ]

Enrollment: 80
Study Start Date: September 2005
Study Completion Date: October 2010
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
Experimental: CpG-ODN Drug: CpG-ODN


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Glioblastoma
  • Karnofsky Performance Status ≥ 60%

Exclusion Criteria:

  • Severe or uncontrolled systemic disease
  • Active auto-immune disease
  • Uncontrolled epilepsia
  • Platelets < 100 000/mm3 ; or Neutrophils <500 /mm3 ; or lymphocytes <300/ mm3
  Contacts and Locations
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Please refer to this study by its identifier: NCT00190424

Hopital Salpetriere
Paris, France, 75013
Hopital Lariboisiere
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Alexandre CARPENTIER, MD, PhD Hopital Lariboisiere, Päris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00190424     History of Changes
Other Study ID Numbers: P050305
Study First Received: September 14, 2005
Last Updated: December 12, 2012

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs processed this record on May 23, 2017