Status:
TERMINATED
Radiation Boost for Newly Diagnosed Glioblastoma Multiforme
Lead Sponsor:
Methodist Healthcare
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
The study design is multi-centered and non-randomized. Patients with newly diagnosed GBM undergoing initial surgical resection will be candidates for this study. Eligible patients will undergo surgica...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00376103
Start Date
August 1 2006
Last Update
September 18 2009
Active Locations (1)
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1
Methodist University Hospital
Memphis, Tennessee, United States, 38104