Gliadel Wafer, Temozolomide and Radiation Therapy for Newly Diagnosed GBM - Full Text View

Sponsored by:	Methodist Healthcare
Information provided by:	Methodist Healthcare
ClinicalTrials.gov Identifier:	NCT00548938

Purpose

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.

Condition	Intervention	Phase
Glioblastoma Multiforme High-Grade Glioma	Drug: Gliadel wafer Drug: Temozolomide Radiation: External Beam Radiation Therapy	Phase II

MedlinePlus related topics: Radiation Therapy Surgery

Drug Information available for: Temozolomide Carmustine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
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

Further study details as provided by Methodist Healthcare:

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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Median, one year and overall survival rate. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Implanted at surgery

During External Beam Radiation

60 Gy

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.

Eligibility

Ages Eligible for Study:	18 Years to 72 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548938

Contacts

Contact: Allen K Sills, MD

(901) 259-5340

asills@semmes-murphey.com

Locations

United States, Tennessee
Methodist University Hospital	Recruiting
Memphis, Tennessee, United States, 38104
Contact: Allen Redmond, RN, BSN 901-259-5314 aredmond@semmes-murphey.com
Principal Investigator: Allen K Sills, MD

Sponsors and Collaborators

Methodist Healthcare

Investigators

Principal Investigator:

Allen K Sills, MD

Methodist University Hospital

More Information

No publications provided

Responsible Party:	Methodist Healthcare ( Allen Sills, MD )
Study ID Numbers:	MHIRB #2007-040
Study First Received:	October 23, 2007
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00548938 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Methodist Healthcare:

Brain Tumor
GBM
Glioblastoma Multiforme
Giladel
Temozolomide

Study placed in the following topic categories:

Glioblastoma
Astrocytoma
Carmustine
Temozolomide
Brain Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal

Neuroepithelioma
Glioma
Glioblastoma Multiforme
Antineoplastic Agents, Alkylating
Alkylating Agents
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Glioblastoma
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Astrocytoma
Antineoplastic Agents
Neoplasms, Nerve Tissue
Carmustine
Temozolomide
Pharmacologic Actions

Neuroectodermal Tumors
Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Glioma
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009