Clinical trial NCT00660621: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Glioma
Keywords: High Grade
Malignant
GBM
Lead sponsor: Kentuckiana Cancer Institute
Sponsor class: OTHER
Collaborators: name: Eisai Inc.
First posted: 2008-04-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: First 5 subjects after 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Kentuckiana Cancer Institute
state: Kentucky
Study officials:
affiliation: Kentuckiana Cancer Instititue
name: Renato V. LaRocca, MD
role: PRINCIPAL_INVESTIGATOR
References: