Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease
- Conditions
- HIV InfectionsHodgkin's Disease
- Registration Number
- NCT00000626
- 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 Hodgkin's disease; to observe the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with Hodgkin's 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 Hodgkin's 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 Hodgkin's 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
St. Louis ConnectCare, Infectious Diseases Clinic
🇺🇸Saint Louis, Missouri, United States
SUNY - Buffalo, Erie County Medical Ctr.
🇺🇸Buffalo, New York, United States
The Ohio State Univ. AIDS CRS
🇺🇸Columbus, Ohio, United States
Washington U CRS
🇺🇸Saint Louis, Missouri, United States
Alabama Therapeutics CRS
🇺🇸Birmingham, Alabama, United States
Northwestern University CRS
🇺🇸Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
USC CRS
🇺🇸Los Angeles, California, United States