Randomized Phase 2 With CpG-ODN in Malignant Glioblastoma

Phase 2

Completed

• Conditions: Glioblastoma
• Interventions: Drug: CpG-ODN

• Registration Number: NCT00190424
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2005-09
• Study Start: 2005-09
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-19
• Primary Completion: 2008-10
• Study Completion: 2010-10
• Last Update Submitted: 2012-12-12
• Last Update Posted: 2012-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CpG-ODN	CpG-ODN	-

Primary Outcome Measures

Name	Time	Method
Survival	2 years

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	2 years
Tolerance	2 years

Trial Locations

Locations (2)

Hopital Salpetriere; 🇫🇷 Paris, France

Hopital Lariboisiere; 🇫🇷 Paris, France