Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001270
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Feasibility Study of Interleukin 1-Alpha With Ifosfamide CBDCA and Etoposide With Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Feasibility Study of Interleukin 1-Alpha With Ifosfamide CBDCA and Etoposide With Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma
Status:
COMPLETED
Status Verified Date:
1999-05
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 is a phase III study of interleukin-1 G-CSF and high dose ICE chemotherapy with autologous bone marrow transplant in patients with relapsed breast testicular and lymphoid cancers The initial goal of this study was to define the toxicity of interleukin-1 administered for 7 days prior to ICE chemotherapy A total of 22 patients have been treated with IL-1 and ICE and results showed a more rapid engraftment 45 days with IL-1 A second cohort of 18 patients also received G-CSF and engraftment was further shortened in some subgroups Overall the median time to engraftment was 16 days with both IL-1 and G-CSF Accrual will continue to further define the toxicity and efficacy of this regimen
Detailed Description:
This is a phase III study of interleukin-1 G-CSF and high dose ICE chemotherapy with autologous bone marrow transplant in patients with relapsed breast testicular and lymphoid cancers The initial goal of this study was to define the toxicity of interleukin-1 administered for 7 days prior to ICE chemotherapy A total of 22 patients have been treated with IL-1 and ICE and results showed a more rapid engraftment 45 days with IL-1 A second cohort of 18 patients also received G-CSF and engraftment was further shortened in some subgroups Overall the median time to engraftment was 16 days with both IL-1 and G-CSF Accrual will continue to further define the toxicity and efficacy of this regimen
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 |
|---|---|---|---|
| 91-C-0156 | None | None | None |