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


Phase 2
40 Years
N/A
Not Enrolling
Both
Glioblastoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Survival

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Alexandre CARPENTIER, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hopital Lariboisiere, Päris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

P050305

NCT ID:

NCT00190424

Start Date:

September 2005

Completion Date:

October 2010

Related Keywords:

  • Glioblastoma
  • Glioblastoma
  • Immunotherapy
  • Glioblastoma

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