Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000987
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of Chemotherapy Plus Azidothymidine in the Treatment of Kaposis Sarcoma in Patients With AIDS
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Study of Combination Chemotherapy Adriamycin Bleomycin and Vincristine and Azidothymidine 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 study the safety and maximum tolerated dose MTD of combined chemotherapy when it is administered to patients with advanced Kaposis sarcoma together with one of two different doses of zidovudine AZT
The combination of AZT and chemotherapy may be effective in treating the tumor as well as preventing the life-threatening infections when used for patients with AIDS and Kaposis sarcoma The MTD of combined chemotherapy is being determined so that the information will be available for future studies when the relative effectiveness of the two doses of AZT has been learned
The combination of AZT and chemotherapy may be effective in treating the tumor as well as preventing the life-threatening infections when used for patients with AIDS and Kaposis sarcoma The MTD of combined chemotherapy is being determined so that the information will be available for future studies when the relative effectiveness of the two doses of AZT has been learned
Detailed Description:
The combination of AZT and chemotherapy may be effective in treating the tumor as well as preventing the life-threatening infections when used for patients with AIDS and Kaposis sarcoma The MTD of combined chemotherapy is being determined so that the information will be available for future studies when the relative effectiveness of the two doses of AZT has been learned
AMENDED AZT by mouth If the treatment is well tolerated subsequent groups of patients are started on increasing doses of doxorubicin combined with the same dose of bleomycin and vincristine After determination of the MTD of chemotherapy in combination with AZT the 2nd phase begins in which AZT is given and the first group of patients is given bleomycin and vincristine only If this combination is well tolerated then the subsequent groups are started on increasing doses of doxorubicin with the same dose of bleomycin vincristine and AZT The MTD of chemotherapy in combination with AZT is then determined Patients achieving maximum response to the tumor are maintained on AZT alone This is an outpatient study and patients are seen every 2 weeks for evaluation with a physical examination every month Original design The combination of chemotherapy and AZT is given to groups of four patients each the first group beginning with bleomycin and vincristine without the addition of doxorubicin The chemotherapy is given intravenously every 2 weeks This is combined first with AZT by mouth
AMENDED AZT by mouth If the treatment is well tolerated subsequent groups of patients are started on increasing doses of doxorubicin combined with the same dose of bleomycin and vincristine After determination of the MTD of chemotherapy in combination with AZT the 2nd phase begins in which AZT is given and the first group of patients is given bleomycin and vincristine only If this combination is well tolerated then the subsequent groups are started on increasing doses of doxorubicin with the same dose of bleomycin vincristine and AZT The MTD of chemotherapy in combination with AZT is then determined Patients achieving maximum response to the tumor are maintained on AZT alone This is an outpatient study and patients are seen every 2 weeks for evaluation with a physical examination every month Original design The combination of chemotherapy and AZT is given to groups of four patients each the first group beginning with bleomycin and vincristine without the addition of doxorubicin The chemotherapy is given intravenously every 2 weeks This is combined first with AZT by mouth
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 |
|---|---|---|---|
| 11049 | REGISTRY | DAIDS ES Registry Number | None |