Randomized Phase 2 With CpG-ODN in Malignant Glioblastoma | NCT00190424

Studies
Randomized Phase 2 With CpG-ODN in Malignant Glioblastoma

NCT00190424

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Dec 13, 2012Estimated

Enrollment

80Actual

Phase

Phase 2

Conditions

Glioblastoma

Interventions

CpG-ODN

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ISOPS 3

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2010Actual

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2012

Last Update Posted Date

Dec 13, 2012Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Label	Type	Description	Intervention Names
control	No Intervention
CpG-ODN	Experimental		Drug: CpG-ODN

Name	Type	Description	Arm Group Labels	Other Names
CpG-ODN	Drug		CpG-ODN

Measure	Description	Time Frame
Survival		2 years

Measure	Description	Time Frame
Progression-free survival		2 years
Tolerance		2 years

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexandre CARPENTIER, MD, PhD	Hopital Lariboisiere, Päris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Salpetriere		Paris	Paris	75013	France
Hopital Lariboisiere

Condition Browse Module

MeSH Terms

ID	Term
D005909	Glioblastoma

Ancestor Terms

ID	Term
D001254	Astrocytoma
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C408982	CPG-oligonucleotide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided