Glioma
Conditions
Keywords
High Grade, Malignant, GBM
Brief 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 and bevacizumab in subjects undergoing initial surgery for newly-diagnosed high grade glioma.
Interventions
Between 14 and 28 days after surgery, all subjects will begin a standard course of post-operative limited field radiation therapy to the tumor site and a surrounding margin with concomitant temozolomide at a daily dose of 75 mg/m2 (7 days/week). No later than 45 days after date of completion of radiation therapy, all subjects will begin dose dense temozolomide at dose of 150 mg/m2 on Days 1-7 and 15-21 of a 28 day cycle with concomitant bevacizumab 10mg/kg administered intravenously every other week.
Sponsors
Eisai Inc.
Kentuckiana Cancer Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Surgery is recommended within 4 weeks of the baseline MRI scan. * Subjects must have a Karnofsky Performance Score of 60 or higher. * 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 and bevacizumab.. * Subjects must have a pathological diagnosis of a high grade (IV) malignant glioma. * 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and efficacy of concomitant limited field radiation therapy and temozolomide, followed by dose dense temozolomide and bevacizumab in subjects undergoing initial surgery for newly-diagnosed high grade glioma. | First 5 subjects after 6 months. |
Countries
United States
Contacts
Primary ContactLeslie Haysley
Backup ContactJulie Kauzlarich
Outcome results
None listed