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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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 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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborators: Keryx / AOI Pharmaceuticals, Inc.; Schering-Plough
• Treatments: Dacarbazine; O(6)-benzylguanine; Temozolomide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.