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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

Phase 1/Phase 2
18 Years
Not Enrolling
Glioblastoma Multiforme

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Trial Information

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

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 surgical resection within 30 days of diagnosis.

Newly diagnosed patients with presumed diagnosis of GBM will undergo surgery for maximal
resection. After frozen section diagnosis of GBM is confirmed, the GliaSite® will be placed
into the tumor cavity.

After the patient recovers from surgery, radiation therapy (60 Gy to 1 cm) is delivered via
the GliaSite®. Radiation therapy with the GliaSite® will be initiated within 21 days after
surgery. Concomitant temozolomide (75 mg/m2/d) is started 2 days prior to radiation therapy
with the GliaSite® and continued for a total of 7 days.

Within 21 days following radiation therapy with the GliaSite®, external beam radiation
therapy (60 Gy in 30 fractions) will be initiated. Concomitant temozolomide (75 mg/m2/d)
will start on day 1 of external beam radiation therapy and continue through the external
beam radiation therapy interval, ending with the last day of radiation.

Four weeks (+/- 2 days) after completion of external beam radiation therapy, temozolomide
(150 mg/m2/d) for 5 days every 28 days will be initiated for one cycle.

At the start of cycle 2, the dose will be escalated to 200 mg/m2/d, if the CTC
non-hematological toxicity for cycle 1 is Grade < 2 (except for alopecia, nausea and

This will continue for up to a total of 12 cycles, unless disease progression or severe
myelosuppression is noted.

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

- Balloon surface within 1 cm of critical structure (brain stem, midbrain, optic
chiasm) on baseline MRI scan

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Treatment-related toxicity.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Allen K Sills, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Methodist University Hospital


United States: Institutional Review Board

Study ID:

MHIRB 2006-032



Start Date:

August 2006

Completion Date:

Related Keywords:

  • Glioblastoma Multiforme
  • Brain Tumor
  • GBM
  • Glioblastoma Multiforme
  • Glioblastoma
  • Brachytherapy
  • Temozolomide
  • Temodar
  • Glioblastoma



Methodist University HospitalMemphis, Tennessee  38104