Ph I 5-day Temozolomide + O6-BG in Treatment of Pts w Recurrent / Progressive GBM

Completed · Phase 1

Conditions studied: Glioblastoma, Gliosarcoma

In brief

Primary objectives To determine maxi tolerated dose of Temodar® in combo w O6-benzylguanine administered for 5 consecutive days in pts w progressive/recurrent GBM To characterize toxicity associated w Temodar® in combo w O6-BG administered for 5 consecutive days in pts w progressive/recurrent GBM To determine Neulasta®-supported MTD defined as the MTD of Temodar® in combo with O6-BG administered for 5 days while receiving Neulasta® once per treatment cycle between days 7 \& 14 in pts w progressive/recurrent GBM To obtain preliminary response rates of Temodar® in combo w O6-BG administered for 5 consecutive days in pts w progressive/recurrent GBM

Key facts

Study ID

NCT00612989

Run by

Duke University

People needed

42

Starts

2005-02-01

Expected to finish

2008-07-01

Last updated by the study team

2014-07-16

Who can join

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

You may qualify if…

• Pts have histologically proven supratentorial GBM
• Pts have recurrent/progressive MG. If pt received stereotactic radiosurgery / brachytherapy as part of their prior therapy, then histologic confirmation of recurrence/metabolic imaging consistent w recurrent tumor is recommended but not mandated
• There must be measurable disease on contrast-enhanced magnetic resonance imaging study / CT scan performed <2wks of study drug administration
• Interval of >12 wks between completion of XRT \& enrollment on protocol
• Interval of >4 wks between prior chemo \& enrollment on protocol unless there is unequivocal evidence of tumor progression
• Interval of >2 wks between prior surgical resection \& enrollment on protocol unless there is unequivocal evidence of tumor progression
• Age >18 yrs
• KPS >70 percent
• Following baseline study will be required <1wk of study drug administration: serum creatinine < 1.5 x ULN \& Hematologic Status
• Following baseline studies will be required <1wk of study drug administration: absolute neutrophil count >2000 cells/microliter; platelet count >125,000 cells/microliter
• Following baseline studies will be required <1 wk of study drug administration: serum SGOT \& total bilirubin < 2.5 x ULN
• Signed informed consent, approved by IRB, will be obtained prior to initiating treatment
• Pts w Reproductive Potential: Pts must agree to practice effective birth control measures while on study \& for 2 months after completing therapy

You may not qualify if…

• Pregnant/breast feeding women/ women/men w reproductive potential not practicing adequate contraception. Therapy may be associated w potential toxicity to fetus/child that exceeds mini risks necessary to meet health needs of mother
• Prior treatment w O6-BG + Temozolomide in combo
• Active infection requiring intravenous antibiotics
• Known diagnosis of HIV infection
• Pts w history of another primary malignancy that is currently clinically significant/currently requires active intervention
• Pts unwilling/unable to comply w protocol due to serious medical/psychiatric condition
• Pts who have received investigational drugs <2 wks prior to start on study drug/have not recovered from side effects of such therapy.

Where it is running

• Duke University Health System — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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