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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

Phase 2
18 Years
75 Years
Open (Enrolling)

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Trial Information

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

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Time Frame:

First 5 subjects after 6 months.

Safety Issue:


Principal Investigator

Renato V. LaRocca, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Kentuckiana Cancer Instititue


United States: Institutional Review Board

Study ID:




Start Date:

April 2008

Completion Date:

December 2010

Related Keywords:

  • Glioma
  • High Grade
  • Malignant
  • GBM
  • Glioma



Kentuckiana Cancer Institute Louisville, Kentucky  40202