Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090909
Status:
COMPLETED
Last Update Posted:
2013-01-08
First Post:
2004-09-07
Brief Title:
Gemcitabine Cisplatin and Dexamethasone in Treating Patients With Relapsed or Refractory Hodgkins Lymphoma
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Study Of Gemcitabine Cisplatin and Dexamethasone In Patients With Relapsed Or Refractory Hodgkin Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-01
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 such as gemcitabine cisplatin and dexamethasone work in different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells
PURPOSE This phase II trial is studying how well giving gemcitabine and cisplatin together with dexamethasone works in treating patients with relapsed or refractory Hodgkins lymphoma
PURPOSE This phase II trial is studying how well giving gemcitabine and cisplatin together with dexamethasone works in treating patients with relapsed or refractory Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the response rate and maximum response in patients with relapsed or refractory Hodgkins lymphoma treated with gemcitabine cisplatin and dexamethasone
Determine time to progression in patients treated with this regimen who are not undergoing stem cell transplantation
Determine the toxicity of this regimen in these patients
OUTLINE This is an open-label study
Patients receive gemcitabine IV over 1 hour on days 1 and 8 cisplatin IV over 3 hours on day 1 and oral dexamethasone twice daily on days 1-4 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed until disease progression
PROJECTED ACCRUAL A total of 18-35 patients will be accrued for this study
Determine the response rate and maximum response in patients with relapsed or refractory Hodgkins lymphoma treated with gemcitabine cisplatin and dexamethasone
Determine time to progression in patients treated with this regimen who are not undergoing stem cell transplantation
Determine the toxicity of this regimen in these patients
OUTLINE This is an open-label study
Patients receive gemcitabine IV over 1 hour on days 1 and 8 cisplatin IV over 3 hours on day 1 and oral dexamethasone twice daily on days 1-4 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed until disease progression
PROJECTED ACCRUAL A total of 18-35 patients will be accrued for this study
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 |
|---|---|---|---|
| LILLY-B9E-US-X394 | None | None | None |
| UCLA-030402301 | None | None | None |