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Randomized Phase 2 With CpG-ODN in Malignant Glioblastoma

Primary Purpose

Glioblastoma

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

CpG-ODN

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring Glioblastoma, Immunotherapy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hopital Salpetriere
Hopital Lariboisiere

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control

CpG-ODN

Arm Description

Outcomes

Primary Outcome Measures

Survival

Secondary Outcome Measures

Progression-free survival

Tolerance

Full Information

NCT ID

NCT00190424

First Posted

September 14, 2005

Last Updated

December 12, 2012

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT00190424

Brief Title

Randomized Phase 2 With CpG-ODN in Malignant Glioblastoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma

Keywords

Glioblastoma, Immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control

Arm Type

No Intervention

Arm Title

CpG-ODN

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

CpG-ODN

Primary Outcome Measure Information:

Title

Survival

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Progression-free survival

Time Frame

2 years

Title

Tolerance

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexandre CARPENTIER, MD, PhD

Organizational Affiliation

Hopital Lariboisiere, Päris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hopital Salpetriere

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Name

Hopital Lariboisiere

City

Paris

ZIP/Postal Code

75018

Country

France

12. IPD Sharing Statement

Learn more about this trial

Randomized Phase 2 With CpG-ODN in Malignant Glioblastoma

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