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NCT00190424 Clinical Trial

Randomized Phase 2 With CpG-ODN in Malignant Glioblastoma

Glioblastoma Clinical Trial

Official title:
Multicentric Randomized Phase 2. Immunotherapy With CpG-ODN in Malignant Glioblastoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00190424
Other study ID # P050305
Secondary ID ISOPS 3
Status Completed
Phase Phase 2
First received September 14, 2005
Last updated December 12, 2012
Start date September 2005
Est. completion date October 2010

Study information
Verified date September 2005
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date October 2010
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• CpG-ODN

Locations
Country Name City State
France Hopital Lariboisiere Paris
France Hopital Salpetriere Paris

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival 2 years No
Secondary Progression-free survival 2 years No
Secondary Tolerance 2 years No
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