Radiation Boost for Newly Diagnosed Glioblastoma Multiforme

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 a combination of surgical resection, brachytherapy and external beam radiation with concomitant temozolomide, followed by adjuvant temozolomide.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Methodist Healthcare
• Treatments: Dacarbazine; Temozolomide

Criteria

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