Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001059
Status:
COMPLETED
Last Update Posted:
2012-04-17
First Post:
1999-11-02
Brief Title:
Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine 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:
Comparison Study of Liposomal Doxorubicin With or Without Bleomycin and Vincristine for the Treatment of Advanced AIDS-Associated Kaposis Sarcoma
Status:
COMPLETED
Status Verified Date:
2012-04
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 evaluate the safety and efficacy of liposomal doxorubicin hydrochloride DOX-SL alone or in combination with bleomycin and vincristine in the long-term treatment of AIDS-related Kaposis sarcoma To determine whether the 3-drug combination enhances progression-free survival and quality of life
Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity Multi-agent therapy is considered to be more effective than single-agent therapy therefore DOX-SL will be combined with bleomycin and vincristine
Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity Multi-agent therapy is considered to be more effective than single-agent therapy therefore DOX-SL will be combined with bleomycin and vincristine
Detailed Description:
Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity Multi-agent therapy is considered to be more effective than single-agent therapy therefore DOX-SL will be combined with bleomycin and vincristine
Patients are randomized to receive intravenous DOX-SL alone or in combination with vincristinebleomycin every 2 weeks Filgrastim granulocyte colony-stimulating factor G-CSF may be given as needed for neutropenia
AS PER AMENDMENT 11796 Based on interim review data it is recommended that subjects receiving DOX-SL plus vincristinebleomycin have vincristinebleomycin discontinued and receive DOX-SL alone unless in the opinion of the treating physician they are benefitting from the DOX-SL plus vincristinebleomycin regimen
Patients are randomized to receive intravenous DOX-SL alone or in combination with vincristinebleomycin every 2 weeks Filgrastim granulocyte colony-stimulating factor G-CSF may be given as needed for neutropenia
AS PER AMENDMENT 11796 Based on interim review data it is recommended that subjects receiving DOX-SL plus vincristinebleomycin have vincristinebleomycin discontinued and receive DOX-SL alone unless in the opinion of the treating physician they are benefitting from the DOX-SL plus vincristinebleomycin regimen
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 |
|---|---|---|---|
| 11262 | REGISTRY | DAIDS ES Registry Number | None |