Randomized Phase 2 With CpG-ODN in Malignant Glioblastoma

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 2

Conditions: Glioblastoma

Treatments: Drug: CpG-ODN

Study type: Interventional

Funder types: Other

Identifiers

NCT00190424

P050305

ISOPS 3

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

control

No Intervention group

CpG-ODN

Experimental group

Treatment:

Drug: CpG-ODN