Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003754
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Thalidomide and Cyclophosphamide in Treating Children With Recurrent or Refractory Childhood Cancers
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Study of Thalidomide and Cyclophosphamide in Patients With Recurrent or Refractory Malignancies
Status:
COMPLETED
Status Verified Date:
2013-06
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 kill tumor cells by stopping the growth of new blood vessels to the tumor Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining thalidomide with chemotherapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining thalidomide and cyclophosphamide in treating children who have recurrent or refractory childhood cancers
PURPOSE Phase II trial to study the effectiveness of combining thalidomide and cyclophosphamide in treating children who have recurrent or refractory childhood cancers
Detailed Description:
OBJECTIVES I Determine the efficacy and toxic effects of thalidomide and cyclophosphamide in patients with recurrent or refractory pediatric malignancies
OUTLINE Patients receive oral thalidomide 4 times daily Cyclophosphamide is administered IV over 1 hour once every 4 weeks beginning on the same day as thalidomide Treatment continues in the absence of unacceptable toxicity or disease progression Tumor response is assessed every 3 months
PROJECTED ACCRUAL A total of 45-80 patients will be accrued for this study within 2 years
OUTLINE Patients receive oral thalidomide 4 times daily Cyclophosphamide is administered IV over 1 hour once every 4 weeks beginning on the same day as thalidomide Treatment continues in the absence of unacceptable toxicity or disease progression Tumor response is assessed every 3 months
PROJECTED ACCRUAL A total of 45-80 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-G99-1498 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066878 | REGISTRY | None | None |
| MSKCC-98088A4 | None | None | None |