Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012116
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2001-03-03
Brief Title:
Temozolomide in Treating Patients With Solid Tumors That Have Spread to the Brain
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Temozolomide For Patients With Cerebral Metastases Who Have Failed Radiation Therapy
Status:
COMPLETED
Status Verified Date:
2012-07
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of temozolomide in treating patients who have advanced solid tumors that have spread to the brain
PURPOSE Phase II trial to study the effectiveness of temozolomide in treating patients who have advanced solid tumors that have spread to the brain
Detailed Description:
OBJECTIVES I Assess the response rate of patients with cerebral metastases who have failed or refused standard therapy when treated with temozolomide II Assess the safety and tolerability of this drug in these patients III Determine the quality of life of patients treated with this drug IV Determine the response rate of systemic disease outside the central nervous system in patients treated with this drug
OUTLINE Patients receive oral temozolomide daily for 6 weeks Treatment repeats every 10 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity Quality of life is assessed on day 1 of each 10-week course Patients are followed for 30 days
PROJECTED ACCRUAL A total of 18-48 patients will be accrued for this study within 2 years
OUTLINE Patients receive oral temozolomide daily for 6 weeks Treatment repeats every 10 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity Quality of life is assessed on day 1 of each 10-week course Patients are followed for 30 days
PROJECTED ACCRUAL A total of 18-48 patients will be accrued for this study within 2 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G01-1919 | None | None | None |
| UCLA-0004059 | None | None | None |
| SPRI-UCLA-0004059 | None | None | None |