Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003113
Status:
TERMINATED
Last Update Posted:
2011-01-17
First Post:
1999-11-01
Brief Title:
Oral Combination Chemotherapy in Treating Elderly Patients With Intermediate or High-Grade Non-Hodgkins Lymphomas
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Oral Combination Chemotherapy in Conjunction With G-CSF in the Treatment of Elderly Patients With Intermediate and High Grade Non-Hodgkins Lymphoma
Status:
TERMINATED
Status Verified Date:
2011-01
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug and giving the drugs in different ways may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of oral combination chemotherapy and G-CSF in elderly patients with intermediate- or high-grade non-Hodgkins lymphomas
PURPOSE Phase II trial to study the effectiveness of oral combination chemotherapy and G-CSF in elderly patients with intermediate- or high-grade non-Hodgkins lymphomas
Detailed Description:
OBJECTIVES
Assess the feasibility and toxicity of oral combination chemotherapy with granulocyte colony-stimulating factor in elderly patients with intermediate and high grade non-Hodgkins lymphoma
Determine the objective response rate response duration and survival in this patient population
OUTLINE All patients receive one cycle of oral chemotherapy 6 weeks in duration Etoposide is given on days 1-3 and cyclophosphamide and procarbazine are given on days 22-31 of each cycle Lomustine is given on day 1 of cycles 1 and 3 only Filgrastim granulocyte colony-stimulating factor G-CSF is given subcutaneously on days 5-21 and 33-42 of each cycle
Patients who have disease progression after one cycle of therapy or at any time thereafter are taken off the study Patients with a complete response after 1 cycle of therapy receive 2 additional cycles of chemotherapy and are observed off treatment Patients with a partial response PR also receive 2 additional cycles of chemotherapy Following the third cycle of chemotherapy if residual disease is confined to 1 or 2 nodal sites patients receive radiation therapy All other patients with a PR are treated at investigators discretion
Patients are followed every 3 months until death
PROJECTED ACCRUAL A maximum of 32 patients will be accrued for this study
Assess the feasibility and toxicity of oral combination chemotherapy with granulocyte colony-stimulating factor in elderly patients with intermediate and high grade non-Hodgkins lymphoma
Determine the objective response rate response duration and survival in this patient population
OUTLINE All patients receive one cycle of oral chemotherapy 6 weeks in duration Etoposide is given on days 1-3 and cyclophosphamide and procarbazine are given on days 22-31 of each cycle Lomustine is given on day 1 of cycles 1 and 3 only Filgrastim granulocyte colony-stimulating factor G-CSF is given subcutaneously on days 5-21 and 33-42 of each cycle
Patients who have disease progression after one cycle of therapy or at any time thereafter are taken off the study Patients with a complete response after 1 cycle of therapy receive 2 additional cycles of chemotherapy and are observed off treatment Patients with a partial response PR also receive 2 additional cycles of chemotherapy Following the third cycle of chemotherapy if residual disease is confined to 1 or 2 nodal sites patients receive radiation therapy All other patients with a PR are treated at investigators discretion
Patients are followed every 3 months until death
PROJECTED ACCRUAL A maximum of 32 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 |
|---|---|---|---|
| P30CA043703 | NIH | None | None |
| CWRU-4496 | OTHER | None | None |
| AMC-1C-93 | None | None | None |
| NCI-G97-1350 | Other Identifier | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |