Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000626
Status:
COMPLETED
Last Update Posted:
2021-10-27
First Post:
1999-11-02
Brief Title:
Phase II Study of Filgrastim G-CSF Plus ABVD in the Treatment of HIV-Associated Hodgkins Disease
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase II Study of Filgrastim G-CSF Plus ABVD in the Treatment of HIV-Associated Hodgkins Disease
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 assess the toxicity of chemotherapy with ABVD doxorubicin bleomycin vinblastine dacarbazine when given with filgrastim granulocyte colony-stimulating factor G-CSF in patients with underlying HIV infection and Hodgkins disease to observe the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with Hodgkins disease
Secondary To determine the durability of tumor response to ABVD plus G-CSF over the 2-year study period to observe the incidence of bacterial and opportunistic infections in HIV-infected patients with Hodgkins disease receiving this regimen to document quality of life of patients receiving this regimen
Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy allowing more timely administration of chemotherapy and improved response
Secondary To determine the durability of tumor response to ABVD plus G-CSF over the 2-year study period to observe the incidence of bacterial and opportunistic infections in HIV-infected patients with Hodgkins disease receiving this regimen to document quality of life of patients receiving this regimen
Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy allowing more timely administration of chemotherapy and improved response
Detailed Description:
Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy allowing more timely administration of chemotherapy and improved response
Study drugs are administered in 28-day cycles to twenty-seven HIV-infected patients with Hodgkins disease ABVD doxorubicin bleomycin vinblastine dacarbazine is administered on days 1 and 15 of each cycle and G-CSF is given on days 2 through 14 and 16 through 28 of each cycle All patients receive four cycles of treatment and are then restaged Patients with a complete response CR following the initial four cycles receive two additional cycles of ABVD G-CSF Patients with a partial response following the initial four cycles receive two additional cycles of ABVD G-CSF and are again restaged those who have achieved a CR at that point then receive two more cycles while those without CR discontinue study therapy Patients with disease progression following the initial four cycles of therapy discontinue treatment on the study Concomitant PCP prophylaxis is administered
Study drugs are administered in 28-day cycles to twenty-seven HIV-infected patients with Hodgkins disease ABVD doxorubicin bleomycin vinblastine dacarbazine is administered on days 1 and 15 of each cycle and G-CSF is given on days 2 through 14 and 16 through 28 of each cycle All patients receive four cycles of treatment and are then restaged Patients with a complete response CR following the initial four cycles receive two additional cycles of ABVD G-CSF Patients with a partial response following the initial four cycles receive two additional cycles of ABVD G-CSF and are again restaged those who have achieved a CR at that point then receive two more cycles while those without CR discontinue study therapy Patients with disease progression following the initial four cycles of therapy discontinue treatment on the study Concomitant PCP prophylaxis is administered
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 |
|---|---|---|---|
| 11124 | REGISTRY | DAIDS ES Registry Number | None |