We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Randomized Phase 2 With CpG-ODN in Malignant Glioblastoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00190424
First Posted: September 19, 2005
Last Update Posted: December 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
The purpose of this study is to determine whether the immunostimulating agent CpG-ODN is effective in the treatment of glioblastoma

Condition Intervention Phase
Glioblastoma Drug: CpG-ODN Phase 2

Study Type: Interventional
Study Design: 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

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00190424     History of Changes
Other Study ID Numbers: P050305
ISOPS 3
First Submitted: September 14, 2005
First Posted: September 19, 2005
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