search
Back to results

Gliadel Wafer, Temozolomide and Radiation Therapy for Newly Diagnosed GBM

Primary Purpose

Glioblastoma Multiforme, High-Grade Glioma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gliadel wafer
Temozolomide
External Beam Radiation Therapy
Sponsored by
Methodist Healthcare
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring Brain Tumor, GBM, Glioblastoma Multiforme, Giladel, Temozolomide

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Methodist University Hospital

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Median, one year and overall survival rate.

Full Information

First Posted
October 23, 2007
Last Updated
September 17, 2009
Sponsor
Methodist Healthcare
search

1. Study Identification

Unique Protocol Identification Number
NCT00548938
Brief Title
Gliadel Wafer, Temozolomide and Radiation Therapy for Newly Diagnosed GBM
Official Title
A Phase II Study of Gliadel, Concomitant Temozolomide and Radiation, Followed by Metronomic Therapy With Temozolomide for Newly Diagnosed Malignant High Grade Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Terminated
Why Stopped
Principal Investigator has left the institution
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
October 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Methodist Healthcare

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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 + 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme, High-Grade Glioma
Keywords
Brain Tumor, GBM, Glioblastoma Multiforme, Giladel, Temozolomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gliadel wafer
Intervention Description
Implanted at surgery
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
During External Beam Radiation
Intervention Type
Radiation
Intervention Name(s)
External Beam Radiation Therapy
Intervention Description
60 Gy
Primary Outcome Measure Information:
Title
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Median, one year and overall survival rate.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen K Sills, MD
Organizational Affiliation
Methodist University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Methodist University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Gliadel Wafer, Temozolomide and Radiation Therapy for Newly Diagnosed GBM

We'll reach out to this number within 24 hrs