Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase I/II Study of Pyrazoloacridine (PZA) in Adults With Newly Diagnosed Glioblastoma Multiforme
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor
cells. Combining chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of pyrazoloacridine followed by
radiation therapy in treating adults who have newly diagnosed supratentorial glioblastoma
multiforme.
OBJECTIVES:
- Determine the maximum tolerated dose, toxicity, and pharmacokinetics of
pyrazoloacridine in adults with newly diagnosed, supratentorial glioblastoma multiforme
treated with pyrazoloacridine followed by radiotherapy.
- Determine the response rate, duration of disease free survival, and survival of
patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to
type of anticonvulsant (hepatic metabolic enzyme inducers vs hepatic metabolic enzyme
moderate inducers or noninducers).
Patients receive pyrazoloacridine (PZA) IV over 3 hours on day 1. Treatment repeats every 3
weeks for a maximum of 4 courses in the absence of disease progression or unacceptable
toxicity. Following completion of PZA treatment, patients undergo cranial irradiation 5 days
a week for 6 weeks.
Cohorts of 3 patients receive escalating doses of PZA until the maximum tolerated dose (MTD)
is determined. Additional patients receive PZA at the MTD.
Patients are followed monthly for survival.
PROJECTED ACCRUAL: A minimum of 3 patients will be accrued for phase I and a total of 18-35
patients will be accrued for phase II of this study.
;
Primary Purpose: Treatment
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