Status:
UNKNOWN
A Phase II Study Of Gliadel, Concomitant Temozolomide And Radiation, Followed By Dose Dense Therapy With Temozolomide Plus Bevacizumab For Newly Diagnosed Malignant High Grade Glioma
Lead Sponsor:
Kentuckiana Cancer Institute
Collaborating Sponsors:
Eisai Inc.
Conditions:
Glioma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 temo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00660621
Start Date
April 1 2008
End Date
December 1 2010
Last Update
January 20 2010
Active Locations (1)
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1
Kentuckiana Cancer Institute
Louisville, Kentucky, United States, 40202