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Randomized Phase 2 With CpG-ODN in Malignant Glioblastoma

NCT ID: NCT00190424

Last Updated: 2012-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2010-10-31

Brief Summary

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

Detailed Description

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Conditions

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Glioblastoma

Keywords

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Glioblastoma Immunotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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control

Group Type NO_INTERVENTION

No interventions assigned to this group

CpG-ODN

Group Type EXPERIMENTAL

CpG-ODN

Intervention Type DRUG

Interventions

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CpG-ODN

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexandre CARPENTIER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hopital Lariboisiere, Päris

Locations

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Hopital Salpetriere

Paris, Paris, France

Site Status

Hopital Lariboisiere

Paris, Paris, France

Site Status

Countries

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France

Other Identifiers

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ISOPS 3

Identifier Type: -

Identifier Source: secondary_id

P050305

Identifier Type: -

Identifier Source: org_study_id