Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000807
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposis Sarcoma After Systemic Chemotherapy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposis Sarcoma After Systemic Chemotherapy
Status:
COMPLETED
Status Verified Date:
2021-10
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:
To assess the toxicity tumor response rate and effect on quality of life of daily low-dose etoposide administered for 7 consecutive days every other week in patients with AIDS-related Kaposis sarcoma that has relapsed or progressed after systemic chemotherapy
Etoposide may be at least as or even more effective and less myelotoxic when given in low doses over prolonged periods of time
Etoposide may be at least as or even more effective and less myelotoxic when given in low doses over prolonged periods of time
Detailed Description:
Etoposide may be at least as or even more effective and less myelotoxic when given in low doses over prolonged periods of time
Patients receive low-dose oral etoposide on days 1 through 7 of every 2-week cycle Patients who achieve a complete or partial response after two cycles and have no toxicity greater than grade 2 may have their dose escalated for subsequent cycles If there are no responses to therapy among the first 14 evaluable patients the study will close if there is at least one objective response to therapy among the first 14 evaluable patients enrollment will continue until all 41 patients are enrolled Patients continue therapy until maximal tumor response either stable disease or complete response is achieved or disease progression occurs
Patients receive low-dose oral etoposide on days 1 through 7 of every 2-week cycle Patients who achieve a complete or partial response after two cycles and have no toxicity greater than grade 2 may have their dose escalated for subsequent cycles If there are no responses to therapy among the first 14 evaluable patients the study will close if there is at least one objective response to therapy among the first 14 evaluable patients enrollment will continue until all 41 patients are enrolled Patients continue therapy until maximal tumor response either stable disease or complete response is achieved or disease progression occurs
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11245 | REGISTRY | DAIDS ES Registry Number | None |