Phase II Trial of Temodar Plus O6-Benzylguanine (O6-BG) (NSC 637037) in the Treatment of Patients With Temodar-Resistant Malignant Glioma
2 separate strata accrued independently of each other: Stratum 1-patients with Glioblastoma
Multiforme (GBM). Stratum 2-patients with Anaplastic Glioma [anaplastic astrocytoma (AA),
anaplastic oligodendroglioma (AO), anaplastic mixed (AA and AO)] .
BG at 120mg/m2 administered intravenously over 1 hour followed immediately by 48-hour
infusion at 30mg/m2/24hrs. Temozolomide 472mg/m2 administered orally, in fasting state,
within 60 minutes of end of the 1-hour administration of BG infusion. Treatment cycles may
be repeated every 28 days following dose of Temodar from previous cycle.
Temodar has been well tolerated by both adults and children with most common toxicity being
mild myelosuppression. Other, less likely, potential toxicities include nausea and vomiting,
constipation, headache, alopecia, rash, burning sensation of skin, esophagitis, pain,
diarrhea, lethargy, hepatotoxicity, anorexia, fatigue and hyperglycemia. Hypersensitivity
reactions have not yet been noted with Temodar. As in the case with many anti-cancer drugs,
Temodar may be carcinogenic. BG toxicities include agitation, lethargy, nausea, vomiting,
rapid heart rate, elevated liver functions, & leukemia; but, not with BG as single agent.
Transient lymphopenia has been seen with BG as single agent.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Radiographic evidence of tumor response
David A. Reardon, MD
Duke University Health System
United States: Food and Drug Administration
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