Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072514
Status:
COMPLETED
Last Update Posted:
2017-06-29
First Post:
2003-11-04
Brief Title:
Gemcitabine Hydrochloride Carboplatin Dexamethasone and Rituximab in Treating Patients With Previously Treated Lymphoid Malignancies
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase II Study Evaluating the Efficacy of Gemcitabine Carboplatin and Dexamethasone and Rituximab for Previously Treated Lymphoid Malignancies
Status:
COMPLETED
Status Verified Date:
2017-05
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 pilot phase II trial studies the side effects and how well giving gemcitabine hydrochloride carboplatin dexamethasone and rituximab together works in treating patients with previously treated lymphoid malignancies Drugs used in chemotherapy such as gemcitabine hydrochloride carboplatin and dexamethasone work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as rituximab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them Giving more than one drug combination chemotherapy and giving monoclonal antibody therapy with chemotherapy may kill more cancer cells
Detailed Description:
OBJECTIVES
I To determine the feasibility and safety of GemcitabineCarboplatinDexamethasone with or without Rituximab in previously treated lymphoid malignancies rituximab will only be evaluated in CD20 positive malignancies
II To determine the efficacy of the above regimen
III To determine the ability to proceed to blood stem peripheral blood collection following the above regimens the impact of above regimen on stem cell reserve
IV To determine remission duration
All patients are treated with gemcitbine carboplatin and dexamethasone Patients with CD20 lymphomas also receive rituximab
After completion of study treatment patients are followed up at 3-4 weeks and then every 6 months for 5 years
I To determine the feasibility and safety of GemcitabineCarboplatinDexamethasone with or without Rituximab in previously treated lymphoid malignancies rituximab will only be evaluated in CD20 positive malignancies
II To determine the efficacy of the above regimen
III To determine the ability to proceed to blood stem peripheral blood collection following the above regimens the impact of above regimen on stem cell reserve
IV To determine remission duration
All patients are treated with gemcitbine carboplatin and dexamethasone Patients with CD20 lymphomas also receive rituximab
After completion of study treatment patients are followed up at 3-4 weeks and then every 6 months for 5 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-2011-00035 | REGISTRY | CTRP Clinical Trial Reporting Program | None |