Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease
Status:
Completed
Trial end date:
1999-02-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)