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Randomized Phase 2 With CpG-ODN in Malignant Glioblastoma

A

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

80 participants in 2 patient groups

control
No Intervention group
CpG-ODN
Experimental group
Treatment:
Drug: CpG-ODN

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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