Clinical trial · Interventional
Gliadel Wafer, Temozolomide and Radiation Therapy for Newly Diagnosed GBM
A Phase II Study of Gliadel, Concomitant Temozolomide and Radiation, Followed by Metronomic Therapy With Temozolomide for Newly Diagnosed Malignant High Grade Glioma
NCT00548938CI-TRIAL-00002649terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Principal Investigator has left the institution
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
| High-Grade Glioma | High-Grade Glioma, NOS | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External Beam Radiation Therapy | Radiation | — | UNRESOLVED |
| Gliadel wafer | Drug | Carmustine | ALIAS |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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.
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- Median, one year and overall survival rate.
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 72 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.