Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098865
Status:
COMPLETED
Last Update Posted:
2014-10-07
First Post:
2004-12-08
Brief Title:
Thalidomide and Temozolomide in Relapsed or Progressive CNS Disease or Neuroblastoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Pilot Study Of Thalidomide With Temozolomide In Patients With Relapsed Or Progressive Brain Tumors Or Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2014-09
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 Thalidomide may stop the growth of tumor cells by stopping blood flow to the tumor Drugs used in chemotherapy such as temozolomide work in different ways to stop tumor cells from dividing so they stop growing or die Combining thalidomide with temozolomide may kill more tumor cells
PURPOSE This phase II trial is studying the effectiveness of combining thalidomide with temozolomide in treating young patients who have relapsed or progressive brain tumors or recurrent neuroblastoma
PURPOSE This phase II trial is studying the effectiveness of combining thalidomide with temozolomide in treating young patients who have relapsed or progressive brain tumors or recurrent neuroblastoma
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility of thalidomide and temozolomide in pediatric patients with relapsed or progressive poor prognosis brain tumors or recurrent neuroblastomas
Secondary
Determine preliminarily evidence of biologic activity of this regimen in these patients
Determine the toxic effects of this regimen in these patients
STATISTICAL DESIGN The primary data analysis will estimate the percentage of patients who can complete 6 months of therapy in the mixed population With a target accrual of 20 patients the 90 confidence for the true feasibility rate will be no wider than 40
Primary
Determine the feasibility of thalidomide and temozolomide in pediatric patients with relapsed or progressive poor prognosis brain tumors or recurrent neuroblastomas
Secondary
Determine preliminarily evidence of biologic activity of this regimen in these patients
Determine the toxic effects of this regimen in these patients
STATISTICAL DESIGN The primary data analysis will estimate the percentage of patients who can complete 6 months of therapy in the mixed population With a target accrual of 20 patients the 90 confidence for the true feasibility rate will be no wider than 40
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 |
|---|---|---|---|
| CDR0000396780 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA006516 |
| P30CA006516 | NIH | None | None |