Radiation Boost for Newly Diagnosed Glioblastoma Multiforme

Stopped early · Phase 1/Phase 2

Conditions studied: Glioblastoma Multiforme

In brief

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.

Key facts

Study ID

NCT00376103

Run by

Methodist Healthcare - Memphis

People needed

3

Starts

2006-08-01

Last updated by the study team

2009-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Methodist University Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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