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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00548938
Other study ID # MHIRB #2007-040
Secondary ID
Status Terminated
Phase Phase 2
First received October 23, 2007
Last updated September 17, 2009
Start date October 2007
Est. completion date October 2010

Study information

Verified date September 2009
Source Methodist Healthcare
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and efficacy of the combination of Gliadel wafers plus surgery and limited field radiation therapy with concomitant temozolomide followed by temozolomide given at an extended dose schedule (metronomic schedule) in patients undergoing initial surgery for newly-diagnosed high grade glioma.


Description:

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 + GliadelĀ® 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.


Recruitment information / eligibility

Status Terminated
Enrollment 40
Est. completion date October 2010
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 72 Years
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Gliadel wafer
Implanted at surgery
Temozolomide
During External Beam Radiation
Radiation:
External Beam Radiation Therapy
60 Gy

Locations

Country Name City State
United States Methodist University Hospital Memphis Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Methodist Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 years No
Secondary Median, one year and overall survival rate. 2 years No
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