Randomized Phase 2 With CpG-ODN in Malignant Glioblastoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00190424
First received: September 14, 2005
Last updated: December 12, 2012
Last verified: September 2005

September 14, 2005
December 12, 2012
September 2005
October 2008   (final data collection date for primary outcome measure)
Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Survival
Complete list of historical versions of study NCT00190424 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Tolerance [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Progression-free survival
  • Tolerance
Not Provided
Not Provided
 
Randomized Phase 2 With CpG-ODN in Malignant Glioblastoma
Multicentric Randomized Phase 2. Immunotherapy With CpG-ODN in Malignant Glioblastoma

The purpose of this study is to determine whether the immunostimulating agent CpG-ODN is effective in the treatment of glioblastoma

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Glioblastoma
Drug: CpG-ODN
  • No Intervention: control
  • Experimental: CpG-ODN
    NO
    Intervention: Drug: CpG-ODN
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
October 2010
October 2008   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00190424
P050305, ISOPS 3
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Alexandre CARPENTIER, MD, PhD Hopital Lariboisiere, Päris
Assistance Publique - Hôpitaux de Paris
September 2005

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