GliomaPhase 2KARE003NCT00660283
A Phase II Study of Gliadel, Concomitant Temozolomide and Radiation, Followed By Dose Dense Therapy With Temozolomide For Newly Diagnosed Malignant High Grade Glioma
A Phase 2 study testing Temozolomide in people with Glioma, run by Kentuckiana Cancer Institute at 1 site in United States.
Trial summary
To determine the safety and efficacy of surgical resection with Gliadel® 3.85% wafer implantation, followed by concomitant limited field radiation therapy and temozolomide, followed by dose dense temozolomide in subjects undergoing initial surgery for newly-diagnosed high grade glioma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioma
- What is being tested?
- Temozolomide
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects, men and women, must be between ages 18 and 75 years.
- Subjects must have radiographic evidence on cranial magnetic resonance imaging (MRI) of a single, contrast-enhancing unilateral supratentorial cerebral tumor (see Section 8.4).
- 3 Surgery is recommended within 4 weeks of the baseline MRI scan.
- 4. Subjects must have a Karnofsky Performance Score of 60 or higher.
- 5. Subjects must have signed an Institutional Review Board (IRB)-approved informed consent prior to any non-standard of care study procedure or no later than the start of dose dense temozolomide.
- 6. Subjects must have a pathological diagnosis of a high grade (IV) malignant glioma.
- 7. Subjects, both men and women, must be willing to avoid pregnancy for up to 2 years after wafer implantation surgery and be counseled regarding the unknown, and potentially harmful, risks to the embryo or fetus from participation in this study.
Who cannot join
- Subjects who have had prior cytoreductive surgery for high-grade glioma. Subjects who have had a diagnostic stereotactic biopsy are eligible.
- Subjects with more than one focus of tumor or tumor crossing the midline as assessed by coronal cranial MRI scan.
- Concomitant significant life-threatening disease from which the subject could reasonably be expected to die within the first 12 months of the study.
- Known hypersensitivity reactions to temozolomide, nitrosoureas or any other components of the Gliadel® wafer.
- Prior CNS radiotherapy.
- Subjects who have received any prior chemotherapy for this malignant glioma prior to the baseline evaluation or subjects who are currently being treated with chemotherapeutic agents.
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- Subjects with fewer than 100,000 platelets per mm3 or fewer than 3.500 leukocytes per mm3.
- Liver function tests greater than or equal to 2.5 times the upper limit of normal (transaminases (SGOT, SGPT), total bilirubin, alkaline phosphatase).
- Serum creatinine equal to or greater than 1.5 times the upper limit of normal, blood urea nitrogen (BUN) equal to or greater than 2.5 times the upper limit of normal.
- Pregnancy, or lactating females or females of childbearing potential not using adequate contraception.
- Participation in any other investigational protocol in the prior twelve months for any type of malignancy.
- Psychological, familial, sociological or geographical conditions which do not permit adequate medical follow-up and compliance with the study protocol.
- Inadequately controlled hypertension (blood pressure systolic > 150 mmHg or diastolic > 100 mmHg).
- Unstable angina or history of myocardial infarction within six months prior to enrollment.
- Evidence of bleeding, diathesis, or coagulopathy. Chronic full-dose anticoagulation with warfarin is not permitted though subjects may be on low molecular weight heparin or fondaparinux.
- Serious non-healing wound, ulcer, or bone fracture.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kentuckiana Cancer Institute
Louisville, Kentucky, 40202
About this study
To determine the safety and efficacy of surgical resection with Gliadel® 3.85% wafer implantation, followed by concomitant limited field radiation therapy and temozolomide, followed by dose dense temozolomide in subjects undergoing initial surgery for newly-diagnosed high grade glioma.
- Conditions
- Glioma
- Being tested
- Temozolomide
- Keywords
- GBM, Newly, diagnosed, malignant, high grade
- Medical subject headings
- Glioma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
(Stage I Treatment) Postoperative concomitant limited-field radiation therapy with daily temozolomide (75 mg/m2) must begin between 14 and 28 days from surgery.
- (Stage II Treatment) temozolomide 150 mg/m2 to be given days 1-7 and 15-21 of a 28 day cycle to begin within 45 days of stop date of concomitant limited field radiation/daily temozolomide (Stage I treatment) up to a maximum of 12 cycles.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy of concomitant limited field radiation therapy and temozolomide, followed by dose dense temozolomide in subjects undergoing initial surgery for newly-diagnosed high grade glioma.
Measured: 1st five subjects at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kentuckiana Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Investigators
- Renato V LaRocca, MD, Principal investigator, Kentuckiana Cancer Instititue
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660283
- Sponsor's protocol ID
- KARE003
- Other IDs
- KARE 003
- Acronym
- KARE003
- Status last verified
- Jan 2010
- First submitted
- 14 Apr 2008
- Last updated
- 20 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Gliadel, Concomitant Temozolomide and Radiation, Followed By Dose Dense Therapy With Temozolomide For Newly Diagnosed Malignant High Grade Glioma
- ClinicalTrials.gov ID
- NCT00660283
- Acronym / sponsor ID
- KARE003 / KARE003
- Conditions
- Glioma
- Keywords
- GBM, Newly, diagnosed, malignant, high grade
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kentuckiana Cancer InstituteUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 17 Apr 2008 (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 surgical resection with Gliadel® 3.85% wafer implantation, followed by concomitant limited field radiation therapy and temozolomide, followed by dose dense temozolomide in subjects undergoing initial surgery for newly-diagnosed 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 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects, men and women, must be between ages 18 and 75 years.
- Subjects must have radiographic evidence on cranial magnetic resonance imaging (MRI) of a single, contrast-enhancing unilateral supratentorial cerebral tumor (see Section 8.4).
- 3 Surgery is recommended within 4 weeks of the baseline MRI scan.
- 4. Subjects must have a Karnofsky Performance Score of 60 or higher.
- 5. Subjects must have signed an Institutional Review Board (IRB)-approved informed consent prior to any non-standard of care study procedure or no later than the start of dose dense temozolomide.
Key exclusion criteria (16 listed)
- Subjects who have had prior cytoreductive surgery for high-grade glioma. Subjects who have had a diagnostic stereotactic biopsy are eligible.
- Subjects with more than one focus of tumor or tumor crossing the midline as assessed by coronal cranial MRI scan.
- Concomitant significant life-threatening disease from which the subject could reasonably be expected to die within the first 12 months of the study.
- Known hypersensitivity reactions to temozolomide, nitrosoureas or any other components of the Gliadel® wafer.
- Prior CNS radiotherapy.
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 |
|---|---|---|
| Temozolomide(Stage I Treatment) Postoperative concomitant limited-field radiation therapy with daily temozolomide (75 mg/m2) must begin between 14 and 28 days from surgery. 7. (Stage II Treatment) temozolomide 150 mg/m2 to be given days 1-7 and 15-21 of a 28 day cycle to begin within 45 days of stop date of concomitant limited field radiation/daily temozolomide (Stage I treatment) up to a maximum of 12 cycles. | Drug | – |
Primary outcome
Safety and efficacy of concomitant limited field radiation therapy and temozolomide, followed by dose dense temozolomide in subjects undergoing initial surgery for newly-diagnosed high grade glioma.
Time frame: 1st five subjects at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2010.
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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 principal investigator
Kentuckiana Cancer Instititue
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 Temozolomide in people with 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 7 inclusion and 16 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 20 Jan 2010. 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?
Safety and efficacy of concomitant limited field radiation therapy and temozolomide, followed by dose dense temozolomide in subjects undergoing initial surgery for newly-diagnosed high grade glioma. (time frame: 1st five subjects at 6 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 20 Jan 2010.