Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000660
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposis Sarcoma
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposis Sarcoma
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 define the toxicity and maximum-tolerated dose of weekly oral etoposide VP-16 in patients with AIDS-related Kaposis sarcoma to determine the clinical pharmacology of orally administered VP-16 in AIDS patients A secondary objective is to obtain preliminary data for determining the effect of oral VP-16 on Kaposis sarcoma
VP-16 is an antitumor agent Previous problems with VP-16 include the route of administration and the toxicities VP-16 has been given intravenously for 3 consecutive days in a 21-day cycle for lung cancer and testicular cancer VP-16 has also been used in lymphoma therapy Oral VP-16 would eliminate the need for an intravenous catheter and so a patient could avoid the pain inconvenience and potential complications associated with medications administered intravenously The relative ease of outpatient administration and the potentially significant antitumor activity of oral VP-16 motivates this study The possibility of weekly drug administration is the other focus of this study
VP-16 is an antitumor agent Previous problems with VP-16 include the route of administration and the toxicities VP-16 has been given intravenously for 3 consecutive days in a 21-day cycle for lung cancer and testicular cancer VP-16 has also been used in lymphoma therapy Oral VP-16 would eliminate the need for an intravenous catheter and so a patient could avoid the pain inconvenience and potential complications associated with medications administered intravenously The relative ease of outpatient administration and the potentially significant antitumor activity of oral VP-16 motivates this study The possibility of weekly drug administration is the other focus of this study
Detailed Description:
VP-16 is an antitumor agent Previous problems with VP-16 include the route of administration and the toxicities VP-16 has been given intravenously for 3 consecutive days in a 21-day cycle for lung cancer and testicular cancer VP-16 has also been used in lymphoma therapy Oral VP-16 would eliminate the need for an intravenous catheter and so a patient could avoid the pain inconvenience and potential complications associated with medications administered intravenously The relative ease of outpatient administration and the potentially significant antitumor activity of oral VP-16 motivates this study The possibility of weekly drug administration is the other focus of this study
Four patients are entered at each dose level starting with level 1 Patients are not entered into the next higher dose level until at least two patients at the previous dose level have completed at least 3 weeks of therapy with grade 2 or less maximum tolerated dose-defining toxicities Treatment is repeated weekly for 52 weeks until either a grade 3 or 4 toxicity occurs or until a patient shows a complete response or progressive disease Patients with a complete response are continued on drug for 4 additional weeks from the time that complete response is first documented Patients with progressive disease are withdrawn from study Patients with partial response or stable disease continue until either unacceptable toxicity occurs or a complete response or progression of disease is reached
Four patients are entered at each dose level starting with level 1 Patients are not entered into the next higher dose level until at least two patients at the previous dose level have completed at least 3 weeks of therapy with grade 2 or less maximum tolerated dose-defining toxicities Treatment is repeated weekly for 52 weeks until either a grade 3 or 4 toxicity occurs or until a patient shows a complete response or progressive disease Patients with a complete response are continued on drug for 4 additional weeks from the time that complete response is first documented Patients with progressive disease are withdrawn from study Patients with partial response or stable disease continue until either unacceptable toxicity occurs or a complete response or progression of disease is reached
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 |
|---|---|---|---|
| 11085 | REGISTRY | DAIDS ES Registry Number | None |