Adult Glioblastoma Clinical Trial
Official title:
Phase I Trial of R115777 With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
This phase I trial is studying the side effects and best dose of tipifarnib when given together with temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma multiforme or gliosarcoma. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining tipifarnib, temozolomide, and radiation therapy may kill more tumor cells.
PRIMARY OBJECTIVES:
I. Establish MTD for R115777 in combination with Temozolomide with radiation in patients not
on EIAEDs.
II. To define the safety of R115777 in combination with Temozolomide with radiation in this
patient population.
III. To assess for evidence of antitumor activity in this patient population.
OUTLINE: This is a multicenter, dose-escalation study of tipifarnib. Patients are stratified
according to concurrent use of enzyme-inducing antiepileptic drugs (yes [closed to accrual
as of 3/15/05] vs no).
COMBINATION THERAPY: Patients receive oral tipifarnib twice daily on days 1-21. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity. Within
5-9 days after beginning tipifarnib, patients receive oral temozolomide once daily for 6
weeks and concurrently undergo partial brain radiotherapy daily 5 days a week for 6 weeks.
After completion of radiotherapy, patients proceed to adjuvant therapy.
Cohorts of 3-6 patients receive escalating doses of tipifarnib until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 10 patients are
treated at the MTD.
ADJUVANT THERAPY: Patients continue to receive tipifarnib as above. With the initiation of
the next planned course of tipifarnib, patients receive oral temozolomide on days 1-5.
Treatment repeats every 28 days for 12 courses OR 1 year (whichever is longer) in the
absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients with progressive disease are followed at 10
weeks and then every 4 months. Patients who complete therapy are followed every 2 months for
1 year, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months
thereafter until disease progression.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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