Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002880
Status:
COMPLETED
Last Update Posted:
2016-06-28
First Post:
1999-11-01
Brief Title:
Etoposide in Treating Patients With Relapsed Non-Hodgkins Lymphoma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
PHASE II STUDY OF ORAL ETOPOSIDE WITH PHARMACODYNAMIC MODELING IN RELAPSED NON-HODGKINS LYMPHOMA IWF GRADES A-H
Status:
COMPLETED
Status Verified Date:
2016-06
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of etoposide in treating patients with relapsed non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of etoposide in treating patients with relapsed non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Evaluate the response rate and response duration in patients with relapsed non-Hodgkins lymphoma when treated with daily oral etoposide II Describe the toxic effects of daily oral etoposide in these patients III Monitor etoposide trough levels and determine whether etoposide concentrations correlate with age response and toxicity
OUTLINE Patients receive oral etoposide daily for 21 days Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity Patients in complete or partial remission receive 2 courses past best response minimum 6 courses Patients with stable disease after 3 courses may be removed from study Patients are followed every 6 months for 2 years then annually for survival
PROJECTED ACCRUAL Approximately 97 patients will be accrued for this study over 2 years
OUTLINE Patients receive oral etoposide daily for 21 days Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity Patients in complete or partial remission receive 2 courses past best response minimum 6 courses Patients with stable disease after 3 courses may be removed from study Patients are followed every 6 months for 2 years then annually for survival
PROJECTED ACCRUAL Approximately 97 patients will be accrued for this study over 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 |
|---|---|---|---|
| CDR0000065180 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CLB-9650 | None | None | None |