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Protocol No.1344GCCPrincipal InvestigatorKwok, Young
PhaseNA (Cancer Control)
Age GroupAdult
TitlePILOT STUDY OF COMBINED OPTUNE, BEVACIZUMAB, AND HYPOFRACTIONATED STEREOTACTIC IRRADIATION FOR BEVACIZUMAB-NAIIVE, RECURRENT GLIOBLASTOMA
DescriptionThis protocol is designed to generate and provide preliminary data to determine the safety and efficacy of combination therapy for recurrent GBM.
TreatmentDrug +Device
Key EligibilityInclusion Criteria:

1. Patients with recurrent or progressive glioblastoma or other grade IV malignant glioma (i.e. glioblastoma, gliosarcoma, small cell glioblastoma, etc.) who have failed prior radiation but who have not progressed/recurred on bevacizumab. Patients will be eligible if the original histology was lower-grade glioma and subsequent diagnosis of glioblastoma or gliosarcoma is made.

2. Patients with any number of recurrences are allowed

3. Brain MRI with contrast demonstrates an enhancing tumor less than or equal to 8 cm in largest diameter within 30 days prior to registration.

4. History and physical including neurological exam, height, weight, cranial skin exam, and Karnofsky performance status greater than or equal to 70% within 30 days prior to registration.

5. Age greater than or equal to 22 years old.

6. Patients must have laboratory values done within 14 days prior to
registration

7. Minimum interval since completion of radiation treatment is 12 weeks.

8. History of CNS radiotherapy: radiation of 60 Gy in 30 fractions, 59.4 Gy in 1.8 Gy fractions, 75 Gy in 30 fractions or equivalent or lower doses

9. Minimum interval since last major surgery (e.g. intra-thoracic, intraabdominal
or intra-pelvic), open biopsy, or significant traumatic injury is 4 weeks prior to registration. Minimum interval since minor procedures,percutaneous biopsies or placement of vascular access device is 1 week prior to registration. Patients must have recovered from side effects of such procedure or injury prior to registration

10. Minimum interval since last investigational agent and/or prior cytotoxic drug therapy (patient must have also recovered from the toxic effects of any prior therapy):
• 3 weeks since last non-cytotoxic therapy.
• 3 weeks must have elapsed since the completion of a non-nitrosourea-containing chemotherapy regimen.
• 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen.

11. Patients must have signed an approved informed consent.

12. Patients with the potential for pregnancy or impregnating their partner must agree to practice effective contraceptive methods to avoid conception while on study and for 6 months after study completion.

13. Female patients of child-bearing potential must have a negative pregnancy test within 14 days prior to study registration.

14. Patients with history of prior invasive malignancy (except non-melanomatous skin cancer and glioblastoma diagnosis) must have been disease free for a minimum of 1 year.

15. Patients must be maintained on a stable or decreasing corticosteroid regimen from the time of their baseline scan until registration.

16. Patients on full-dose anticoagulants (e.g., warfarin or LMW heparin) must meet both of the following criteria:
• No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices).
• In-range INR (maxless than or equal to 3) on a stable dose of oral anticoagulant for greater than 1 month or on a stable dose of low molecular weight heparin.


*For more information on Exclusion Criteria please, call study site contact.
Applicable Disease SitesBrain and Nervous System
Therapies InvolvedRadiotherapy
Drugs InvolvedAvastin (Bevacizumab)
Bevacizumab
StatusOpen
Treatment TypeTreatment
ContactGreenebaum Cancer Center Caroline Poff, MS, R.N. Phone:410-369-5264
Pager:
Email:CAROLINE.POFF@umm.edu
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