Glioblastoma Multiforme Clinical Trial
Official title:
A Phase I/II Trial of Maximal Resection, Local Radiation Boost With Concomitant Temozolomide, Followed by External Radiation Therapy With Concomitant Temozolomide for the Treatment of Newly Diagnosed Glioblastoma Multiforme
Verified date | September 2009 |
Source | Methodist Healthcare |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to determine treatment related toxicity, tumor response, progression-free survival and quality of life of newly diagnosed Glioblastoma Multiforme (GBM) patients undergoing a combination of surgical resection, brachytherapy and external beam radiation with concomitant temozolomide, followed by adjuvant temozolomide.
Status | Terminated |
Enrollment | 3 |
Est. completion date | |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Newly diagnosed, unifocal, unilateral, supratentorial lesion seen on MRI and suspicious for Glioblastoma Multiforme - Subject must be a candidate for surgical resection of the tumor mass with feasible gross total resection - Age 18 years or older - Subject must be an appropriate candidate to receive brachytherapy and temozolomide per the GliaSite RTS and temozolomide IFU - The tumor must be histopathologically confirmed by intra-operative frozen section and by final pathology - Karnofsky Performance Status (KPS) => 70 - Negative pregnancy test if a female of childbearing age and not surgically sterilized - Male or female subject agrees to use acceptable birth control methods while receiving treatment (if not surgically sterile) - Life expectancy > 3 months - Adequate laboratory results: ANC => 1.5 x 109/L. Platelets => 100 x 109/L - Subject or legal representative must provide informed consent and HIPAA authorization prior to surgery Exclusion Criteria: - Prior use of temozolomide - Presence or history of severe hepatic or renal impairment - Subject cannot tolerate temozolomide therapy due to NPO status or intractable nausea and vomiting - Subject with prior intracranial malignancy - Major medical illness or psychiatric impairments that in the investigators opinion will prevent administration or completion of the protocol therapy - Subject has pacemaker or other MRI non-compatible metal in the body - Previous radiation to the head/neck or brain - Pregnant or lactating women - Patient has allergy to iodine and/or dacarbazine - Creatinine > 1.5x upper limits of normal (ULN), AST > 3x ULN - Chemotherapy within the last 6 months - Residual tumor >1 cm (in a single dimension) on baseline MRI scan (T1 post-gadolinium images) - Balloon surface within 1 cm of critical structure (brain stem, midbrain, optic chiasm) on baseline MRI scan |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Methodist University Hospital | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Methodist Healthcare |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment-related toxicity. | 1 year | No | |
Secondary | 6 month, 1 year and overall survival. | End of study | No | |
Secondary | Tumor progression. | End of study | No | |
Secondary | Progression-free survival. | End of study | No | |
Secondary | Quality of life. | End of study | No |
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