Newly Diagnosed Supratentorial Malignant GliomaPhase 2NCT00283543
Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma
A Phase 2 study testing Gliadel Wafer, Temozolomide and Limited field radiation in people with Newly Diagnosed Supratentorial Malignant Glioma, run by Kentuckiana Cancer Institute at 1 site in United States.
Trial summary
To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and radiation with Temozolomide Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Newly Diagnosed Supratentorial Malignant Glioma
- What is being tested?
- Gliadel Wafer, Temozolomide and Limited field radiation
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Apr 2008
- 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 18 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MRI showing unilateral supratentorial cerebral tumor
- surgical tx within 4 weeks of baseline MRI
- KPS 60% or higher
- moderate to high grade malignant glioma
Who cannot join
- prior cytoreductive surgery for moderate or high grade glioma
- prior CNS radiotherapy
- prior chemo for this glioma
- more than one focus of tumor or tumor crossing the midline per MRI
- life expectancy less than 12 months
- sensitivity to temozolomide, nitrosoureas, or Gliadel wafer
Trial locations and contacts
1 site in 1 country.
United States1 site
Kentuckiana Cancer Institute
Louisville, Kentucky, 40202
About this study
Official title: A Phase II Study of Radiation With Concomitant and Then Sequential Temozolomide in Patients With Newly Diagnosed Supratentorial Malignant Glioma Who Have Undergone Surgery With Gliadel Wafer Insertion
To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and radiation with Temozolomide
Read the detailed description
A phase II study of radiation with concomitant and then sequential Temozolomide in patients with newly diagnosed supratentorial malignant glioma who have undergone surgery with Gliadel wafer insertion. To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and limited field radiation therapy with concomitant Temozolomide followed by Temozolomide alone in patients undergoing initial surgery for newly diagnosed unifocal moderate to high grade glioma.
- Being tested
- Gliadel Wafer, Temozolomide, Limited field radiation
- Keywords
- Glioma, Gliadel Wafer
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gliadel WaferDrug
TemozolomideDrug
Limited field radiationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and efficacy of Gliadel 3.85% wafers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2006 (estimated)
- Study startSep 2002
- Study completionApr 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Supratentorial Malignant GliomaStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kentuckiana Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Investigators
- Renato V. LaRocca, MD, Study director, Kentuckiana Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283543
- Sponsor's protocol ID
- 1068016
- Other IDs
- 128-02
- Status last verified
- Oct 2007
- First submitted
- 26 Jan 2006
- Last updated
- 31 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Radiation With Concomitant and Then Sequential Temozolomide in Patients With Newly Diagnosed Supratentorial Malignant Glioma Who Have Undergone Surgery With Gliadel Wafer Insertion
- ClinicalTrials.gov ID
- NCT00283543
- Acronym / sponsor ID
- 1068016
- Keywords
- Glioma, Gliadel Wafer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kentuckiana Cancer InstituteUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- Sep 2002
- Study completion
- Apr 2008 (estimated)
- First posted
- 30 Jan 2006 (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.
To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and radiation with Temozolomide
Detailed description
A phase II study of radiation with concomitant and then sequential Temozolomide in patients with newly diagnosed supratentorial malignant glioma who have undergone surgery with Gliadel wafer insertion. To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and limited field radiation therapy with concomitant Temozolomide followed by Temozolomide alone in patients undergoing initial surgery for newly diagnosed unifocal moderate to high grade glioma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- MRI showing unilateral supratentorial cerebral tumor
- surgical tx within 4 weeks of baseline MRI
- KPS 60% or higher
- moderate to high grade malignant glioma
Key exclusion criteria (6 listed)
- prior cytoreductive surgery for moderate or high grade glioma
- prior CNS radiotherapy
- prior chemo for this glioma
- more than one focus of tumor or tumor crossing the midline per MRI
- life expectancy less than 12 months
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 |
|---|---|---|
| Gliadel Wafer | Drug | – |
| Temozolomide | Drug | – |
| Limited field radiation | Procedure or surgery | – |
Primary outcome
To determine the safety and efficacy of Gliadel 3.85% wafers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2007.
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Active, not recruiting
Optune for Children With High-Grade Glioma or Ependymoma, and Optune With Radiation Therapy for Children With DIPG
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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.
Renato V. LaRocca, MD study director
Kentuckiana Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gliadel Wafer, Temozolomide and Limited field radiation in people with Newly Diagnosed Supratentorial Malignant Glioma, run by Kentuckiana Cancer Institute 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 Oct 2007. 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 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?
Results are not available in the source record.
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 determine the safety and efficacy of Gliadel 3.85% wafers. 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 31 Oct 2007.