Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038493
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2002-05-31
Brief Title:
Temozolomide and SCH66336 for Recurrent Glioblastoma Multiforme
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Evaluation Temozolomide and Farnesyl Transferase Inhibitor SCH66336 for the Treatment of Recurrent and Progressive Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will combine the chemotherapy agent temozolomide with the investigational drug SCH66336 an agent which interferes with new cell growth Patients will be treated with oral temozolomide on days 1-5 and oral SCH66336 on days 8-28 every 28 days
Detailed Description:
Temozolomide at a dose of 150-200 mgm2 will be administered orally after fasting for one hour once a day for 5 consecutive days days 1 through 5 every 4 weeks plus up to 3 days The starting dose level of 200 mgm2 will be used for patients who have not previously received any chemotherapy or at 150 mgm2 for patients who have received previous chemotherapy
SCH66336 will be given orally with water in the morning and in the evening for three weeks Days 8 - 28 every 28 days plus up to 3 days 1 hour before or after morning and evening meals Patients will take 150 mg in the morning and 150 mg in the evening
Treatment courses may be repeated every 28 days following the first daily dose of Temozolomide for the previous course
SCH66336 will be given orally with water in the morning and in the evening for three weeks Days 8 - 28 every 28 days plus up to 3 days 1 hour before or after morning and evening meals Patients will take 150 mg in the morning and 150 mg in the evening
Treatment courses may be repeated every 28 days following the first daily dose of Temozolomide for the previous course
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None