A Phase II Study of Gliadel, Concomitant Temozolomide and Radiation, Followed by Metronomic Therapy With Temozolomide for Newly Diagnosed Malignant High Grade Glioma
18 Years
72 Years
Both
Glioblastoma Multiforme, High-Grade Glioma
Trial Information
A Phase II Study of Gliadel, Concomitant Temozolomide and Radiation, Followed by Metronomic Therapy With Temozolomide for Newly Diagnosed Malignant High Grade Glioma
The patient population in this Phase II clinical trial will be patients with newly diagnosed
high-grade glioma undergoing initial surgery. Patients will receive Surgery + Gliadel®
wafer implantation + Limited Field Radiation Therapy with concomitant daily temozolomide (75
mg/m2) followed by monthly temozolomide given at the same dose (75 mg/m2 per day for 21 days
each month.
Patients will have up to 8 wafers implanted into the tumor resection cavity (depending upon
its size) after maximal tumor resection. Between Study Days 14 and 45 all patients will
begin a standard course of post-operative limited field radiation therapy to the tumor site
and a surrounding margin. Temozolomide will be administered concomitantly with radiation at
a daily dose of 75 mg/m2 daily (7 days/week) and then beginning no later than 30 days
following completion of radiation therapy on a 75 mg/m2 daily dose given 21 days out of each
month for a total of up to 18 cycles.
Inclusion Criteria:
- Men and women, must be between ages 18-72
- Patients must have radiographic evidence on cranial magnetic resonance imaging (MRI)
of a single, contrast-enhancing unilateral supratentorial cerebral tumor suggestive
of high-grade glioma
- Surgical treatment within 4 weeks of the baseline MRI is indicated
- Karnofsky Performance Score of 60 or higher
- Patients must have a pathological diagnosis of high-grade (IV) malignant glioma
- Patients must be willing to use a barrier method of contraception if fertile or if of
childbearing potential for up to 2 years after wafer implantation and be counseled
regarding the unknown, and potentially harmful, risks to the embryo or fetus while
treated on this study
Exclusion Criteria:
- Patients who have had prior cytoreductive surgery for high-grade glioma (patients who
have had a diagnostic stereotactic biopsy are eligible)
- Patients 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 patient could
reasonably be expected to die within the first 12 months of the study
- Known hypersensitivity reactions to temozolomide, nitrosoureas or any components of
the Gliadel wafer
- Prior CNS radiotherapy
- Patients who have received any prior chemotherapy for malignant glioma prior to the
baseline evaluation or patients who are currently being treated with chemotherapeutic
agents
- Patients 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 employing
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the efficacy of Gliadel wafer + radiation + temozolomide in patients with newly diagnosed high grade glioma undergoing surgery as determined by time to disease progression.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Allen K Sills, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Methodist University Hospital
Authority:
United States: Institutional Review Board
Study ID:
MHIRB #2007-040
NCT ID:
NCT00548938
Start Date:
October 2007
Completion Date:
October 2010
Related Keywords:
- Glioblastoma Multiforme
- High-Grade Glioma
- Brain Tumor
- GBM
- Glioblastoma Multiforme
- Giladel
- Temozolomide
- Glioblastoma
- Glioma
Name | Location |
|---|---|
| Methodist University Hospital | Memphis, Tennessee 38104 |
