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Randomized Phase 2 With CpG-ODN in Malignant Glioblastoma

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ClinicalTrials.gov Identifier: NCT00190424
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : December 13, 2012
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: CpG-ODN Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Multicentric Randomized Phase 2. Immunotherapy With CpG-ODN in Malignant Glioblastoma
Study Start Date : September 2005
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: control
Experimental: CpG-ODN Drug: CpG-ODN



Primary Outcome Measures :
  1. Survival [ Time Frame: 2 years ]

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


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00190424


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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00190424     History of Changes
Other Study ID Numbers: P050305
ISOPS 3
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: December 13, 2012
Last Verified: September 2005

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Glioblastoma
Immunotherapy

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
CPG-oligonucleotide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs