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

• Status: Unknown status
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kentuckiana Cancer Institute
• Collaborator: Eisai Inc.
• Treatments: Bevacizumab; Dacarbazine; Temozolomide

Criteria

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.