Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251797
Status:
COMPLETED
Last Update Posted:
2010-01-07
First Post:
2005-11-08
Brief Title:
A Phase I Trial Using Combination Irinotecan and Thalidomide for Recurrent CNS Tumors
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
A Phase I Trial Using Combination Irinotecan and Thalidomide for Recurrent CNS Tumors
Status:
COMPLETED
Status Verified Date:
2008-10
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:
The study will try to answer these questions
1 What is the highest dose of thalidomide brain cancer patients can receive safely in combination with irinotecan
2 How well does this combination work to shrink brain tumors and how long do responses to treatment last
3 What side effects does the combination of drugs cause
4 How does treatment affect patients quality of life how they feel and what activities they are able to do
1 What is the highest dose of thalidomide brain cancer patients can receive safely in combination with irinotecan
2 How well does this combination work to shrink brain tumors and how long do responses to treatment last
3 What side effects does the combination of drugs cause
4 How does treatment affect patients quality of life how they feel and what activities they are able to do
Detailed Description:
This is a Phase I study which means these trials are generally comparatively small and are used to determine toxicity and maximum dose Currently there are no standard treatments for Recurrent CNS Tumors In this study approximately 14 patients with Recurrent CNS Tumors will receive treatment with irinotecan an intravenous drug and thalidomide a drug taken by mouth Both have been approved by the Federal Food and Drug Administration as treatments for cancer but they have not been tested together for brain cancer
The study will try to answer these questions
1 What is the highest dose of thalidomide brain cancer patients can receive safely in combination with irinotecan
2 How well does this combination work to shrink brain tumors and how long do responses to treatment last
3 What side effects does the combination of drugs cause
4 How does treatment affect patients quality of life how they feel and what activities they are able to do
The study will try to answer these questions
1 What is the highest dose of thalidomide brain cancer patients can receive safely in combination with irinotecan
2 How well does this combination work to shrink brain tumors and how long do responses to treatment last
3 What side effects does the combination of drugs cause
4 How does treatment affect patients quality of life how they feel and what activities they are able to do
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