Louisville, Kentucky 40202


Purpose:

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.


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.


NCT ID:

NCT00660621


Primary Contact:

Principal Investigator
Renato V. LaRocca, MD
Kentuckiana Cancer Instititue

Leslie Haysley
Phone: 502-561-8200 ext. 248
Email: lhaysley@kci.us


Backup Contact:

Email: jkauzlarich@kci.us
Julie Kauzlarich
Phone: 502-561-8200 ext. 286


Location Contact:

Louisville, Kentucky 40202
United States

Roxann R. Smalley, JD
Phone: 502-561-8200
Email: rsmalley@kci.us

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 22, 2018

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