Breast Cancer Clinical Trial
Official title:
Randomized, Double Blinded, Placebo-Controlled Trial of Antibacterial Prophylaxis for the Prevention of Bacterial Infections in the Post-Engraftment Phase After Allogeneic Hematopoeitic Stem Cell Transplantation
RATIONALE: A donor stem cell transplant can lower the body's immune system, making it
difficult to fight off infection. Giving antibiotics, such as moxifloxacin, may help prevent
bacterial infections in patients who have recently undergone donor stem cell transplant. It
is not yet known whether moxifloxacin is more effective than a placebo in preventing
bacterial infections in patients who have recently undergone donor stem cell transplant.
PURPOSE: This randomized phase III trial is studying moxifloxacin to see how well it works
compared with a placebo in preventing bacterial infections in patients who have recently
undergone donor stem cell transplant.
OBJECTIVES:
Primary
- Assess the safety and tolerability of giving prophylactic moxifloxacin hydrochloride
during the post-engraftment phase in patients who have undergone allogeneic stem cell
transplantation. (Pilot study)
- Compare the efficacy, in terms of reducing the incidence of clinically and
microbiologically documented bacterial infections, in patients who have undergone
allogeneic stem cell transplantation treated with prophylactic moxifloxacin
hydrochloride vs placebo during the post-engraftment phase. (Phase III)
Secondary
- Determine the incidence of clinically and microbiologically documented bacterial
infections in these patients. (Pilot study)
- Assess the impact of moxifloxacin hydrochloride on the incidence of bacteremia in these
patients. (Phase III)
- Compare the percentage of time on systemic antibiotics and days hospitalized in
patients treated with these regimens. (Phase III)
- Compare the incidence of veno-occlusive disease of the liver in patients treated with
these regimens. (Phase III)
- Compare the incidence and severity of graft-versus-host disease in patients treated
with these regimens. (Phase III)
- Compare the infection-related mortality and overall mortality of patients treated with
these regimens.
OUTLINE: This is a pilot study followed by a randomized, double-blind, placebo-controlled,
multicenter phase III study. Patients are stratified according to gender and race (white vs.
non-white). The first 20 patients are assigned to the pilot study.
Patients assigned to the pilot study receive oral moxifloxacin hydrochloride once daily
beginning after neutrophil recovery (ANC > 1,500/mm³) from allogeneic stem cell
transplantation (ASCT) and continuing until day 100 post-transplantation in the absence of
disease progression or unacceptable toxicity. Subsequent patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients receive oral moxifloxacin hydrochloride once daily beginning after
neutrophil recovery (ANC > 1,500/mm³) from ASCT and continuing until day 100
post-transplantation.
- Arm II: Patients receive oral placebo once daily beginning after neutrophil recovery
(ANC > 1,500/mm³) from ASCT and continuing until day 100 post-transplantation.
In both arms, treatment continues in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed at day 120 post-transplantation.
PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study.
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