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Protocol No.1224GCCPrincipal InvestigatorKwok, Young
PhasePhase II (Cancer Control)
Age GroupAdult
TitlePhase II Trial of Low-Dose Whole Brain Radiotherapy with Concurrent Temozolomide and Adjuvant Temozolomide in Patients with Newly-Diagnosed Glioblastoma Multiforme
DescriptionTo determine the feasibility and safety of low-dose whole brain radiation therapy (WBRT) when given concurrently to the standard TMZ and focal partial brain RT.
-To determine the efficacy of WBRT with concurrent TMZ as measured by decreased distant disease recurrence rate.

TreatmentRadiation Therapy and Chemotherapy (Temozolomide)
Key EligibilityCriteria for Eligibility:

1. Histologically proven diagnosis of glioblastoma or gliosarcoma (WHO grade IV).

2. History and physical with neurological examination, steroid documentation, height, and weight within 14 days of registration.

3. A diagnostic contrast-enhanced MRI (or CT) of the brain must be performed preoperatively and postoperatively prior to the initiation of radiotherapy. The postoperative scan must be performed within 28 days prior to registration.

4. Karnofsky performance status greater than or equal to 70 or ECOG performance status less than or equal to 2.

5. Age greater than or equal to 18.

6. CBC/differential obtained within 14 days prior to registration, with adequate bone marrow function.

7. Adequate renal function within 14 days prior to registration.

8. Adequate hepatic function within 14 days prior to registration.

9. Systolic blood pressure less than or equal to 160 mg Hg or diastolic pressure less than or equal to 90 mg Hg within 14 days prior to registration.

10. Patient must provide study specific informed consent prior to study entry.

11. For women of child-bearing potential, negative serum pregnancy test within 14 days prior to registration.

12. Women of childbearing potential and male participants must practice adequate contraception.

"Please contact Study Site Coordinator, for more information."
Applicable Disease SitesBrain and Nervous System
Therapies InvolvedRadiotherapy
Drugs InvolvedTemozolomide
Treatment TypeTreatment
ContactGreenebaum Comprehensive Cancer Center: Caroline Poff, MS, R.N. Phone:410-369-5264
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