NCT00190424

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

December 13, 2012

Status Verified

September 1, 2005

Enrollment Period

3.1 years

First QC Date

September 14, 2005

Last Update Submit

December 12, 2012

Conditions

Glioblastoma

Keywords

GlioblastomaImmunotherapy

Outcome Measures

Primary Outcomes (1)

  • Survival

    2 years

Secondary Outcomes (2)

  • Progression-free survival

    2 years

  • Tolerance

    2 years

Study Arms (2)

control

NO INTERVENTION

CpG-ODN

EXPERIMENTAL
Drug: CpG-ODN

Interventions

CpG-ODNDRUG
CpG-ODN

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Glioblastoma
  • Karnofsky Performance Status ≥ 60%

You may not qualify if:

  • Severe or uncontrolled systemic disease
  • Active auto-immune disease
  • Uncontrolled epilepsia
  • Platelets \< 100 000/mm3 ; or Neutrophils \<500 /mm3 ; or lymphocytes \<300/ mm3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hopital Salpetriere

Paris, Paris, 75013, France

Location

Hopital Lariboisiere

Paris, Paris, 75018, France

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

CPG-oligonucleotide

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Alexandre CARPENTIER, MD, PhD

    Hopital Lariboisiere, Päris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 19, 2005

Study Start

September 1, 2005

Primary Completion

October 1, 2008

Study Completion

October 1, 2010

Last Updated

December 13, 2012

Record last verified: 2005-09

Locations

FR(2)