Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000954
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study of Chemotherapy Plus ddI or ddC in the Treatment of AIDS-Related 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 III Study of Combination Chemotherapy Adriamycin Bleomycin - Vincristine and Dideoxyinosine ddI or Dideoxycytidine ddC in the Treatment of AIDS-Related 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 determine the toxicity and response to treatment with cytotoxic chemotherapy using doxorubicin Adriamycin bleomycin and vincristine DBV for advanced AIDS-related Kaposis sarcoma in combination with either didanosine ddI or zalcitabine dideoxycytidine ddC
AIDS patients with extensive Kaposis sarcoma require treatment with effective cytotoxic agents to reduce the tumor burden and they also require treatment with other possibly effective antiretroviral agents such as ddI or ddC to ameliorate delay the development of opportunistic infections
AIDS patients with extensive Kaposis sarcoma require treatment with effective cytotoxic agents to reduce the tumor burden and they also require treatment with other possibly effective antiretroviral agents such as ddI or ddC to ameliorate delay the development of opportunistic infections
Detailed Description:
AIDS patients with extensive Kaposis sarcoma require treatment with effective cytotoxic agents to reduce the tumor burden and they also require treatment with other possibly effective antiretroviral agents such as ddI or ddC to ameliorate delay the development of opportunistic infections
In Phase I eligible patients with advanced Kaposis sarcoma are randomly assigned to either ddI or ddC in combination with DBV chemotherapy On the average patients receive 12-44 weeks of combined chemotherapy and antiretroviral therapy If vincristine is deleted from Phase I because of excess neurotoxicity it will not be administered as part of the combination chemotherapy if that treatment is continued in the Phase II study The Phase II trial proceeds when at least six cycles 12 weeks of DBV have been completed by six patients enrolled in Phase I and an overall evaluation of tolerance to each combination treatment plan has been completed Study medication is administered as in Phase I with the possible deletion of vincristine All patients who complete DBV chemotherapy with complete or partial response or stable disease will continue to receive the originally assigned investigational antiretroviral drug ddC or ddI for an additional 24 weeks
In Phase I eligible patients with advanced Kaposis sarcoma are randomly assigned to either ddI or ddC in combination with DBV chemotherapy On the average patients receive 12-44 weeks of combined chemotherapy and antiretroviral therapy If vincristine is deleted from Phase I because of excess neurotoxicity it will not be administered as part of the combination chemotherapy if that treatment is continued in the Phase II study The Phase II trial proceeds when at least six cycles 12 weeks of DBV have been completed by six patients enrolled in Phase I and an overall evaluation of tolerance to each combination treatment plan has been completed Study medication is administered as in Phase I with the possible deletion of vincristine All patients who complete DBV chemotherapy with complete or partial response or stable disease will continue to receive the originally assigned investigational antiretroviral drug ddC or ddI for an additional 24 weeks
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 |
|---|---|---|---|
| 11138 | REGISTRY | DAIDS ES Registry Number | None |