Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001114
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Interferon Alfa-2B Plus Didanosine in Patients With Kaposis Sarcoma
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Phase II Trial to Determine the Safety Tolerance and Efficacy of Two Doses of Interferon Alfa-2b Combined With Didanosine in Patients With 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:
Primary To evaluate the safety toxicity and antitumor activity of two doses of interferon alfa-2b IFN-alpha combined with a fixed dose of didanosine ddI in patients with Kaposis sarcoma associated with HIV infection
Secondary To evaluate the effects of combined IFN-alpha and ddI treatment on HIV expression and markers of immune function
Previous studies have shown that IFN-alpha can induce regression of Kaposis sarcoma and suppression of HIV in some patients Although various trials using IFN-alpha in combination with the nucleoside analogue zidovudine have demonstrated a high degree of antitumor activity and evidence of HIV suppression the overlapping toxicity primarily neutropenia of these two agents has proven dose-limiting The toxicity profile of ddI suggests that this drug may be better tolerated than zidovudine when combined with IFN-alpha
Secondary To evaluate the effects of combined IFN-alpha and ddI treatment on HIV expression and markers of immune function
Previous studies have shown that IFN-alpha can induce regression of Kaposis sarcoma and suppression of HIV in some patients Although various trials using IFN-alpha in combination with the nucleoside analogue zidovudine have demonstrated a high degree of antitumor activity and evidence of HIV suppression the overlapping toxicity primarily neutropenia of these two agents has proven dose-limiting The toxicity profile of ddI suggests that this drug may be better tolerated than zidovudine when combined with IFN-alpha
Detailed Description:
Previous studies have shown that IFN-alpha can induce regression of Kaposis sarcoma and suppression of HIV in some patients Although various trials using IFN-alpha in combination with the nucleoside analogue zidovudine have demonstrated a high degree of antitumor activity and evidence of HIV suppression the overlapping toxicity primarily neutropenia of these two agents has proven dose-limiting The toxicity profile of ddI suggests that this drug may be better tolerated than zidovudine when combined with IFN-alpha
Up to 90 patients are randomized to receive either low or high doses of IFN-alpha 1 or 10 million Unitsday in combination with a fixed dose of ddI Fourteen patients are initially entered at each dose level If no objective antitumor responses are observed among the first 14 patients at a given dose no further patients are entered on that treatment arm If one or more antitumor responses are seen at a given dose up to 45 patients may be entered on that treatment arm Patients must complete at least 4 weeks of study therapy to be considered evaluable for tumor response Treatment is continued until tumor progression or unacceptable toxicity occurs PER AMENDMENT 91996 NOTE - After 16 weeks of treatment subjects may receive any FDA approved antiretroviral drug regimen in addition to or in place of ddI
Up to 90 patients are randomized to receive either low or high doses of IFN-alpha 1 or 10 million Unitsday in combination with a fixed dose of ddI Fourteen patients are initially entered at each dose level If no objective antitumor responses are observed among the first 14 patients at a given dose no further patients are entered on that treatment arm If one or more antitumor responses are seen at a given dose up to 45 patients may be entered on that treatment arm Patients must complete at least 4 weeks of study therapy to be considered evaluable for tumor response Treatment is continued until tumor progression or unacceptable toxicity occurs PER AMENDMENT 91996 NOTE - After 16 weeks of treatment subjects may receive any FDA approved antiretroviral drug regimen in addition to or in place of ddI
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 |
|---|---|---|---|
| 11183 | REGISTRY | DAIDS ES Registry Number | None |