Gliadel Wafer, Temozolomide and Radiation Therapy for Newly Diagnosed GBM

NCT00548938 | Terminated Phase 2 DMC

• 1 other identifier: MHIRB #2007-040
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma Multiforme; High-Grade Glioma

Keywords

Brain Tumor; GBM; Glioblastoma Multiforme; Giladel; Temozolomide

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Median, one year and overall survival rate.

  2 years

Interventions

Gliadel wafer DRUG

Implanted at surgery

Temozolomide DRUG

During External Beam Radiation

External Beam Radiation Therapy RADIATION

60 Gy

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Methodist Healthcare: lead

Study Sites (1)

Methodist University Hospital

Memphis, Tennessee, 38104, United States

Location

MeSH Terms

Conditions

Glioblastoma; Glioma; Brain Neoplasms

Interventions

Carmustine; Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Dacarbazine; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Allen K Sills, MD

  Methodist University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 23, 2007
• First Posted: October 24, 2007
• Study Start: October 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2010
• Last Updated: September 18, 2009

Record last verified: 2009-09

Locations

US (1)