Glioblastoma MultiformePhase 1/2NCT00984438
Surgery With Implantable Biodegradable Carmustine (BCNU) Wafer Followed by Chemo for Patients With Recurrent Glioblastoma Multiforme
A Phase 1/2 study testing BCNU Wafer, Irinotecan and Bevacizumab in people with Glioblastoma Multiforme, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this research study is to try and identify a more effective treatment plan to improve survival rates for patients with a recurrent Glioblastoma Multiforme (GBM) brain tumor that can be removed by brain surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- BCNU Wafer, Irinotecan and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jun 2010
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically proven diagnosis of GBM in the past with MRI findings compatible with disease recurrence. Multifocal disease is permitted.
- Must have had prior treatment with standard doses of Temodar
- KPS >50; ECOG <3
- Predicted life expectancy of > 3 months
- Study entry must be within 5 weeks of surgical resection
Who cannot join
- Prior exposure to VEGF inhibitors or Irinotecan
- Intracranial bleed as defined by CT or MRI less than 6 months prior to entry
- GI bleed less than 6 months prior to entry
- Uncontrolled concurrent illness that would limit compliance with study requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Trial for Patients With Recurrent Resectable Glioblastoma Multiforme Using Surgery With Implantable BCNU Polymer Followed by Post-operative Irinotecan and Bevacizumab
The purpose of this research study is to try and identify a more effective treatment plan to improve survival rates for patients with a recurrent Glioblastoma Multiforme (GBM) brain tumor that can be removed by brain surgery.
The study will record what effects (good and bad) the combination of surgery with chemotherapy wafers inserted in the spot where the patient's tumor was during your surgery and post-operative chemotherapy has on the patient and their survival rate over the next 12 months.
- Conditions
- Glioblastoma Multiforme
- Being tested
- BCNU Wafer, Irinotecan, Bevacizumab
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCNU WaferDrug
Also called Gliadel Wafer
Implantable during surgical resection into the tumor bed
IrinotecanDrug
Also called CPT-11
IV every 2 weeks for up to one year
BevacizumabDrug
Also called Avastin
IV every 2 weeks for up to one year
| Study group | Role | What they receive |
|---|---|---|
| BCNU wafter followed by chemotherapy | Experimental | Surgical Implantable BCNU wafer followed by Chemotherapy with Irinotecan and Bevacizumab for up to one year Receives: Drug: BCNU Wafer; Drug: Irinotecan; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess disease free survival
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: No accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Sponsor
- Investigators
- Margie Gerena-Lewis, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984438
- Sponsor's protocol ID
- 08081101
- Status last verified
- Jun 2013
- First submitted
- 24 Sep 2009
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial for Patients With Recurrent Resectable Glioblastoma Multiforme Using Surgery With Implantable BCNU Polymer Followed by Post-operative Irinotecan and Bevacizumab
- ClinicalTrials.gov ID
- NCT00984438
- Acronym / sponsor ID
- 08081101
- Conditions
- Glioblastoma Multiforme
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 25 Sep 2009 (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 research study is to try and identify a more effective treatment plan to improve survival rates for patients with a recurrent Glioblastoma Multiforme (GBM) brain tumor that can be removed by brain surgery.
The study will record what effects (good and bad) the combination of surgery with chemotherapy wafers inserted in the spot where the patient's tumor was during your surgery and post-operative chemotherapy has on the patient and their survival rate over the next 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCNU wafter followed by chemotherapy | Experimental | Drug: BCNU Wafer, Drug: Irinotecan, Drug: BevacizumabSurgical Implantable BCNU wafer followed by Chemotherapy with Irinotecan and Bevacizumab for up to one year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histopathologically proven diagnosis of GBM in the past with MRI findings compatible with disease recurrence. Multifocal disease is permitted.
- Must have had prior treatment with standard doses of Temodar
- KPS >50; ECOG <3
- Predicted life expectancy of > 3 months
- Study entry must be within 5 weeks of surgical resection
Key exclusion criteria (4 listed)
- Prior exposure to VEGF inhibitors or Irinotecan
- Intracranial bleed as defined by CT or MRI less than 6 months prior to entry
- GI bleed less than 6 months prior to entry
- Uncontrolled concurrent illness that would limit compliance with study requirements
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 |
|---|---|---|
| BCNU WaferAlso: Gliadel WaferImplantable during surgical resection into the tumor bed | Drug | BCNU wafter followed by chemotherapy |
| IrinotecanAlso: CPT-11IV every 2 weeks for up to one year | Drug | BCNU wafter followed by chemotherapy |
| BevacizumabAlso: AvastinIV every 2 weeks for up to one year | Drug | BCNU wafter followed by chemotherapy |
Primary outcome
To assess disease free survival
Time frame: 6 and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
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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.
Margie Gerena-Lewis, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BCNU Wafer, Irinotecan and Bevacizumab in people with Glioblastoma Multiforme, run by University of Cincinnati at 1 site in United States.
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 5 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: withdrawn, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
To assess disease free survival (time frame: 6 and 12 months). 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 25 Nov 2019.