Status:
COMPLETED
Ph I 5-day Temozolomide + O6-BG in Treatment of Pts w Recurrent / Progressive GBM
Lead Sponsor:
Duke University
Collaborating Sponsors:
Schering-Plough
Keryx / AOI Pharmaceuticals, Inc.
Conditions:
Glioblastoma
Gliosarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
1 primary objective is to determine maximum tolerated dose of Temodar in combo w O6-benzylguanine administered for 5 consecutive days in pts w progressive/recurrent GBM. Another primary objective is t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2008
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00612989
Start Date
February 1 2005
End Date
July 1 2008
Last Update
July 16 2014
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710