GlioblastomaPhase 2NCT00190424
Randomized Phase 2 With CpG-ODN in Malignant Glioblastoma
A Phase 2 study testing CpG-ODN in people with Glioblastoma, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
The purpose of this study is to determine whether the immunostimulating agent CpG-ODN is effective in the treatment of glioblastoma Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- CpG-ODN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2005to Oct 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Glioblastoma
- Karnofsky Performance Status ≥ 60%
Who cannot join
- Severe or uncontrolled systemic disease
- Active auto-immune disease
- Uncontrolled epilepsia
- Platelets < 100 000/mm3 ; or Neutrophils <500 /mm3 ; or lymphocytes <300/ mm3
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hopital Salpetriere
Paris, Paris, 75013
Hopital Lariboisiere
Paris, Paris, 75018
About this study
Official title: Multicentric Randomized Phase 2. Immunotherapy With CpG-ODN in Malignant Glioblastoma
The purpose of this study is to determine whether the immunostimulating agent CpG-ODN is effective in the treatment of glioblastoma
- Conditions
- Glioblastoma
- Being tested
- CpG-ODN
- Keywords
- Glioblastoma, Immunotherapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CpG-ODNDrug
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described |
| CpG-ODN | Experimental | Not described Receives: Drug: CpG-ODN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 2 years
Secondary outcomes (2)
Progression-free survival
Measured: 2 years
Tolerance
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionOct 2008
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre CARPENTIER, MD, PhD, Principal investigator, Hopital Lariboisiere, Päris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190424
- Sponsor's protocol ID
- P050305
- Other IDs
- ISOPS 3
- Status last verified
- Sep 2005
- First submitted
- 14 Sep 2005
- Last updated
- 13 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Randomized Phase 2. Immunotherapy With CpG-ODN in Malignant Glioblastoma
- ClinicalTrials.gov ID
- NCT00190424
- Acronym / sponsor ID
- P050305
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the immunostimulating agent CpG-ODN is effective in the treatment of glioblastoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | – |
| CpG-ODN | Experimental | Drug: CpG-ODN |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Glioblastoma
- Karnofsky Performance Status ≥ 60%
Key exclusion criteria (4 listed)
- Severe or uncontrolled systemic disease
- Active auto-immune disease
- Uncontrolled epilepsia
- Platelets < 100 000/mm3 ; or Neutrophils <500 /mm3 ; or lymphocytes <300/ mm3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CpG-ODN | Drug | CpG-ODN |
Primary outcome
Survival
Time frame: 2 years
2 secondary outcomes
Progression-free survival
Time frame: 2 years
Tolerance
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre CARPENTIER, MD, PhD principal investigator
Hopital Lariboisiere, Päris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CpG-ODN in people with Glioblastoma, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2012.