Study #SWOG S0816
A Phase II Trial of Response-Adapted Therapy of Stage III/IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging
Michelle A. Fanale
The goal of this clinical research study is to find out if switching from a standard chemotherapy combination to a more intensive experimental combination, based on imaging scans, will improve response to treatment in patients with Hodgkin lymphoma (HL). The safety of this experimental chemotherapy combination will also be studied.
Treatment Location: N/A
The co-primary objectives are: 1a. To estimate the 2-year progression-free survival (PFS) in human immunodeficiency virus (HIV)-negative patients with advanced stage Hodgkin Lymphoma (HL) treated with response-adapted therapy based on FDG-PET imaging after 2 cycles of adriamycin, bleomycin, vinblastine, and dacarbazine (ABVD). 1b. To estimate the 2-year PFS in the subset of HIV-negative patients with advanced stage HL who are PET-positive after 2 cycles of ABVD and are subsequently treated with escalated dose BEACOPP (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, and Prednisone). Secondary objectives include: 1. To estimate the 2-year overall survival (OS) for HIV-negative patients treated with response- adapted therapy. 2. To estimate the response rate (complete and partial) for HIV-negative patients treated with response- adapted therapy. 3. To evaluate the toxicity of this response-adapted regimen. 4. To document the feasibility of centralized, real-time review of 2-Deoxy-2- [18F]fluoro-D-Glucose positron emission tomography FDG-PET imaging for U.S. cooperative group studies. 5. To prospectively evaluate the overall response rate, complete response rate, PFS, and OS of a cohort of HIV-positive patients with HL treated with response-adapted therapy. The use of cycle-2 PET scanning in HIV infection will be done to provide preliminary data for this strategy in HIV-infected patients. 6. To prospectively identify serum and tissue biomarkers associated with progression-free and overall survival of patients with HL treated with response-adapted therapy. Biologic features meriting specific investigation include the degree of tumor cell infiltration with Tregulatory cells, the FOXP3/Granzyme B ratio, and the expression of micro architectural level (MAL) or Bcl-2 in biopsy samples, and Thymus and Activation Regulated Chemokine (TARC) levels in serum specimens. 7.To prospectively evaluate HIV viral load and CD4 cells in the cohort of HIV-positive patients with HL treated with response-adapted therapy.
IRB Review and Approval Date: 12/03/2009
Recruitment Status: Closed
Projected Accrual: N/A
Information and next steps
Michelle A. Fanale
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