Tipifarnib, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma
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|ClinicalTrials.gov Identifier: NCT00049387|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma||Drug: tipifarnib Drug: temozolomide Radiation: radiation therapy||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of R115777 With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||June 2007|
Experimental: Treatment (tipifarnib, temozolomide, radiation therapy)
See Detailed Description
Radiation: radiation therapy
Undergo partial brain radiation therapy
- MTD of tipifarnib [ Time Frame: Week 10 ]Safety variables will be summarized by descriptive statistics. Adverse events that occur will be reported for each dose level and described in terms of incidence and severity. Laboratory data will be presented by dose level at each observation time. Values outside of normal limits will be identified and their frequency calculated. Parameters will be described based on the CTCAE severity grading. Distribution by CTCAE severity grade (when applicable) and clinical relevance will be given.
- Incidence of adverse events [ Time Frame: Up to 5 years ]Safety variables will be summarized by descriptive statistics. Adverse events that occur will be reported for each dose level and described in terms of incidence and severity. Laboratory data will be presented by dose level at each observation time. Values outside of normal limits will be identified and their frequency calculated. Parameters will be described based on the CTCAE severity grading. Distribution by CTCAE severity grade (when applicable) and clinical relevance will be given.
- Antitumor activity [ Time Frame: Up to 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049387
|United States, Maryland|
|Adult Brain Tumor Consortium|
|Baltimore, Maryland, United States, 21231-1000|
|Principal Investigator:||Timothy Cloughesy||National Cancer Institute (NCI)|